Qualitative SEM analysis of fracture surfaces for dental ceramics and polymers broken by flexural strength testing and crown compression.

PURPOSE: To perform qualitative analysis using scanning electron microscopy (SEM) of fracture surfaces for ceramic and polymeric dental materials broken via standardized flexural and crunch-the-crown (CTC) tests. MATERIALS AND METHODS: Zirconia, glass-ceramic, and polymeric (Trilor; TRI, Juvora; JUV, Pekkton; PEK) materials were loaded using crowns for CTC tests, discs (zirconia and glass-ceramics) for piston-on-3 ball tests, bars (polymer) for 3-point bend tests, and bars (zirconia, glass-ceramics) for 4-point bend tests. SEM was used to characterize the fracture surfaces and identify fracture surface features (e.g., origin, mist, hackle, and the direction of crack propagation [DCP]). Electron dispersive spectroscopy was used to identify the local chemistry. RESULTS: Fracture surface features were found to be less visually apparent for glass-ceramics than zirconia. For zirconia bars, fractures originated roughly midway between the corner and center for processing defects related to sintering. Fractures originated at the bottom corners of glass-ceramic bars (void or surface flaw) and PEK bars (surface flaw). TRI bar failures exposed glassy fibers. Fracture features were generally less discernable for discs compared to bars for zirconia and glass-ceramics. Ceramic crowns fractured into 2 to 3 pieces, with fractures originating at the occlusal surface and clear evidence for the DCP. Failures of TRI and JUV specimens (bars and crowns) were less catastrophic than for the ceramics, with exposed fibers (TRI) and surface cracks (JUV). PEK crown and bar fractures presented dimple (ductile) features formed due to microvoid coalescence followed by brittle crack propagation. CONCLUSIONS: The critical flaws responsible for failure initiation were a function of material composition and test configuration. Fractographic analysis can reveal problems associated with the manufacturing of materials, their handling, grinding and finishing/polishing procedures, the structural design and choice of material, and the quality of the final laboratory-delivered restoration.

An experimental study of flexural strength and hardness of zirconia and their relation to crown failure loads.

STATEMENT OF PROBLEM: Dental zirconia is often marketed and selected for restorative use based upon the biaxial flexural strength of prefabricated specimens (disks) without considering other mechanical and physical properties. PURPOSE: The purpose of this in vitro study was to test whether 4-point flexural strength, biaxial flexural strength, and/or hardness may correlate with failure loads for crowns made of different zirconia materials. MATERIAL AND METHODS: Three brands of zirconia (BruxZir, Cercon, and Katana) were used to fabricate anatomically contoured crowns, rectangular bars, and circular disks. The sample size was n=15 specimens per zirconia brand and specimen shape. The bars were tested for 4-point flexural strength by using the 4-point bending (4PB) test and Vickers hardness (VH), while the disks were tested for biaxial flexural strength by using a piston-on-3 ball (POB) test. Crowns were attached to resin abutments and compressed with a steel spherical indenter through a polyethylene sheet to assess the failure loads by using the "crunch the crown" (CTC) test. One-way ANOVA (α=.05) was used to test for statistically significant differences between groups, and Weibull analysis was used to assess the variability of the measured flexural strengths, failure load, and hardness. RESULTS: Statistical differences (P<.001) were found in comparing Cercon, BruxZir, and Katana ([4260 N=4186 N]>3195 N, respectively) with the CTC test and (396 MPa>[281 MPa=275 MPa], respectively) the 4PB test. No statistical differences (P=.084) were found among the zirconia brands (Cercon [384 MPa]=Bruxzir [359 MPa]=Katana [416 MPa]) for the POB test. No significant correlations (P>.05) were found between the 4PB, POB, or VH tests and the corresponding CTC test. The Weibull modulus varied for the different specimen geometries. CONCLUSIONS: The piston-on-3 ball, 4-point bending, and Vickers hardness test results were not correlated with the corresponding crunch-the-crown test.

A Project Course Sequence in Innovation and Commercialization of Medical Devices.

There exists a need for educational processes in which students gain experience with design and commercialization of medical devices. This manuscript describes the implementation of, and assessment results from, the first year offering of a project course sequence in Master of Engineering (MEng) in Design and Commercialization at our institution. The three-semester course sequence focused on developing and applying hands-on skills that contribute to product development to address medical device needs found within our university hospital and local community. The first semester integrated computer-aided drawing (CAD) as preparation for manufacturing of device-related components (hand machining, computer numeric control (CNC), three-dimensional (3D) printing, and plastics molding), followed by an introduction to microcontrollers (MCUs) and printed circuit boards (PCBs) for associated electronics and control systems. In the second semester, the students applied these skills on a unified project, working together to construct and test multiple weighing scales for wheelchair users. In the final semester, the students applied industrial design concepts to four distinct device designs, including user and context reassessment, human factors (functional and aesthetic) design refinement, and advanced visualization for commercialization. The assessment results are described, along with lessons learned and plans for enhancement of the course sequence.

Team-Based Development of Medical Devices: An Engineering-Business Collaborative.

There is a global shift in the teaching methodology of science and engineering toward multidisciplinary, team-based processes. To meet the demands of an evolving technical industry and lead the way in engineering education, innovative curricula are essential. This paper describes the development of multidisciplinary, team-based learning environments in undergraduate and graduate engineering curricula focused on medical device design. In these programs, students actively collaborate with clinicians, professional engineers, business professionals, and their peers to develop innovative solutions to real-world problems. In the undergraduate senior capstone courses, teams of biomedical engineering (BME) and business students have produced and delivered numerous functional prototypes to satisfied clients. Pursuit of commercialization of devices has led to intellectual property (IP) disclosures and patents. Assessments have indicated high levels of success in attainment of student learning outcomes and student satisfaction with their undergraduate design experience. To advance these projects toward commercialization and further promote innovative team-based learning, a Master of Engineering (MEng) in Design and Commercialization was recently launched. The MEng facilitates teams of graduate students in engineering, life sciences, and business who engage in innovation-commercialization (IC) projects and coursework that take innovative ideas through research and development (R&D) to create marketable devices. The activities are structured with students working together as a "virtual company," with targeted outcomes of commercialization (license agreements and new start-ups), competitive job placement, and/or career advancement.

Biomechanical Analysis of Screws Versus K-Wires for Lateral Humeral Condyle Fractures.

BACKGROUND: Good outcomes have been described for pediatric lateral condyle fractures treated by open reduction and fixation using either screws or Kirschner wires (K-wires). No studies have compared the biomechanical properties of the 2 fixation methods. We hypothesized that screw fixation would be more biomechanically stable than K-wire fixation. METHODS: Synthetic humerus models were used for biomechanical testing, following a previously published protocol. A miter saw was used to make an oblique cut to simulate a Milch type II fracture. Fractures were anatomically reduced and fixed with either 2 divergent 0.062-inch K-wires placed bicortically or a 4.0-mm lag screw placed obliquely (perpendicular to the fracture line). Specimens were then embedded in polymethyl methacrylate bone cement for testing. Mechanical testing using displacement control was performed applying compression or distraction from 0 to 1.5 mm at a rate of 0.5 mm/s for 10 cycles. The maximum force was calculated based on the maximum force averaged over the 10 cycles. Stiffness was calculated based on the slope of the force-displacement curve of the 10th cycle. A 2-sample t test was used to determine significant differences between the stiffness and maximum force comparing the K-wire and screw groups. A P-value of <0.05 was considered statistically significant. RESULTS: Stiffness and maximum force in tension testing were significantly greater with screw fixation compared with K-wire fixation. Testing in compression revealed statistically significant increased maximum force and a trend towards increased stiffness. CONCLUSION: Screw fixation in a synthetic bone model of pediatric lateral condyle fractures (Milch type II) provides increased biomechanical stability of the construct as compared with K-wires. CLINICAL RELEVANCE: If similar effects were seen in vivo, increased biomechanical stability with screw fixation could decrease the occurrence of complications such as loss of reduction and nonunion.

A course in medical device design & commercialization for medical students pursuing surgical fields.

BACKGROUND: The modern surgeon faces an ever-changing landscape of procedural innovation. The demands of present-day healthcare highlight the importance of successfully developing new medical devices and technologies. This effort requires multidisciplinary collaborations of professionals ranging from manufacturers and engineers to researchers and healthcare providers. Surgeons regularly interact with complex equipment and user interfaces without substantial formal education on their design and development. The objective of this study was to ascertain the impact of a 10-week BME course into a medical school curriculum on surgery-bound students' knowledge of product design and gauge their ability to develop an actual product to meet a real need in a surgical field. METHODS: A Medical Device Design and Commercialization co-enrolled elective course was offered to medical students at a single institution. Five students with an expressed surgical and procedural interest were enrolled. At the beginning of the course, they were tasked with developing a product to meet a clinical need they observed. At the conclusion of the course, students filled out a questionnaire about their level of comfort and knowledge of the material using a 5-point Likert scale. This survey was administered to a control group of medical students who did not take the course. RESULTS: The BME student cohort was able to successfully identify a post-operative need, develop a prototype of a novel device, and present their product to attending surgeons. A total of 35 survey entries were received: five from the experimental group and 30 from the comparison group. The experimental group scored higher than the comparison group for all survey questions and reached the level of statistical significance in 13 of the 15 questions (p < 0.05). Survey respondents reported similar degrees of knowledge and comfort in recognizing unmet needs in a hospital setting and formulating a comprehensive statement describing them. CONCLUSION: The principles of biomedical engineering are integral to advancing the field of surgery. Presently, a small cohort of medical students/residents successfully acquired and applied basic BME concepts in a relatively short period of time relative to other training paradigms. Our findings also suggest medical students recognize unmet needs in the hospital setting, and those who completed a BME course felt more able to take steps to meet those needs. Early integration of biomedical engineering principles in medical training may help produce more innovative and well-rounded surgeons.

A novel device to quantify the mechanical properties of electrospun nanofibers.

Mechanical deformation of cell-seeded electrospun matrices plays an important role in cell signaling. However, electrospun biomaterials have inherently complex geometries due to the random deposition of fibers during the electrospinning process. This confounds attempts at quantifying strains exerted on adherent cells during electrospun matrix deformation. We have developed a novel mechanical test platform that allows deposition and tensile testing of electrospun fibers in a highly parallel arrangement to simplify mechanical analysis of the fibers alone and with adherent cells. The device is capable of optically recording fiber strain in a cell culture environment. Here we report on the mechanical and viscoelastic properties of highly parallel electrospun poly(ε-caprolactone) fibers. Force-strain data derived from this device will drive the development of cellular mechanotransduction studies as well as the customization of electrospun matrices for specific engineered tissue applications.

Activation of the hypoxia-inducible factor-1alpha pathway accelerates bone regeneration.

The hypoxia-inducible factor-1alpha (HIF-1alpha) pathway is the central regulator of adaptive responses to low oxygen availability and is required for normal skeletal development. Here, we demonstrate that the HIF-1alpha pathway is activated during bone repair and can be manipulated genetically and pharmacologically to improve skeletal healing. Mice lacking pVHL in osteoblasts with constitutive HIF-1alpha activation in osteoblasts had markedly increased vascularity and produced more bone in response to distraction osteogenesis, whereas mice lacking HIF-1alpha in osteoblasts had impaired angiogenesis and bone healing. The increased vascularity and bone regeneration in the pVHL mutants were VEGF dependent and eliminated by concomitant administration of VEGF receptor antibodies. Small-molecule inhibitors of HIF prolyl hydroxylation stabilized HIF/VEGF production and increased angiogenesis in vitro. One of these molecules (DFO) administered in vivo into the distraction gap increased angiogenesis and markedly improved bone regeneration. These results identify the HIF-1alpha pathway as a critical mediator of neoangiogenesis required for skeletal regeneration and suggest the application of HIF activators as therapies to improve bone healing.

Fabrication and characterization of a thick, viable bi-layered stem cell-derived surrogate for future myocardial tissue regeneration.

Cardiac tissue surrogates show promise for restoring mechanical and electrical function in infarcted left ventricular (LV) myocardium. For these cardiac surrogates to be usefulin vivo, they are required to support synchronous and forceful contraction over the infarcted region. These design requirements necessitate a thickness sufficient to produce a useful contractile force, an area large enough to cover an infarcted region, and prevascularization to overcome diffusion limitations. Attempts to meet these requirements have been hampered by diffusion limits of oxygen and nutrients (100-200 µm) leading to necrotic regions. This study demonstrates a novel layer-by-layer (LbL) fabrication method used to produce tissue surrogates that meet these requirements and mimic normal myocardium in form and function. Thick (1.5-2 mm) LbL cardiac tissues created from human induced pluripotent stem cell-derived cardiomyocytes and endothelial cells were assessed,in vitro, over a 4-week period for viability (<5.6 ± 1.4% nectrotic cells), cell morphology, viscoelastic properties and functionality. Viscoelastic properties of the cardiac surrogates were determined via stress relaxation response modeling and compared to native murine LV tissue. Viscoelastic characterization showed that the generalized Maxwell model of order 4 described the samples well (0.7

3D printed mesh reinforcements enhance the mechanical properties of electrospun scaffolds.

BACKGROUND: There is substantial interest in electrospun scaffolds as substrates for tissue regeneration and repair due to their fibrous, extracellular matrix-like composition with interconnected porosity, cost-effective production, and scalability. However, a common limitation of these scaffolds is their inherently low mechanical strength and stiffness, restricting their use in some clinical applications. In this study we developed a novel technique for 3D printing a mesh reinforcement on electrospun scaffolds to improve their mechanical properties. METHODS: A poly (lactic acid) (PLA) mesh was 3D-printed directly onto electrospun scaffolds composed of a 40:60 ratio of poly(ε-caprolactone) (PCL) to gelatin, respectively. PLA grids were printed onto the electrospun scaffolds with either a 6 mm or 8 mm distance between the struts. Scanning electron microscopy was utilized to determine if the 3D printing process affected the archtitecture of the electrospun scaffold. Tensile testing was used to ascertain mechanical properties (strength, modulus, failure stress, ductility) of both unmodified and reinforced electrospun scaffolds. An in vivo bone graft model was used to assess biocompatibility. Specifically, reinforced scaffolds were used as a membrane cover for bone graft particles implanted into rat calvarial defects, and implant sites were examined histologically. RESULTS: We determined that the tensile strength and elastic modulus were markedly increased, and ductility reduced, by the addition of the PLA meshes to the electrospun scaffolds. Furthermore, the scaffolds maintained their matrix-like structure after being reinforced with the 3D printed PLA. There was no indication at the graft/tissue interface that the reinforced electrospun scaffolds elicited an immune or foreign body response upon implantation into rat cranial defects. CONCLUSION: 3D-printed mesh reinforcements offer a new tool for enhancing the mechanical strength of electrospun scaffolds while preserving the advantageous extracellular matrix-like architecture. The modification of electrospun scaffolds with 3D-printed reinforcements is expected to expand the range of clinical applications for which electrospun materials may be suitable.

Biomechanical response of the pubic symphysis in lateral pelvic impacts: a finite element study.

Automotive side impacts are a leading cause of injuries to the pubic symphysis, yet the mechanisms of those injuries have not been clearly established. Previous mechanical testing of isolated symphyses revealed increased joint laxity following drop tower lateral impacts to isolated pelvic bone structures, which suggested that the joints were damaged by excessive stresses and/or deformations during the impact tests. In the present study, a finite element (FE) model of a female pelvis including a previously validated symphysis sub-model was developed from computed tomography data. The full pelvis model was validated against measured force-time impact responses from drop tower experiments and then used to study the biomechanical response of the symphysis during the experimental impacts. The FE models predicted that the joint underwent a combination of lateral compression, posterior bending, anterior/posterior and superior/inferior shear that exceeded normal physiological levels prior to the onset of bony fractures. Large strains occurred concurrently within the pubic ligaments. Removal of the contralateral constraints to better approximate the boundary conditions of a seated motor vehicle occupant reduced cortical stresses and deformations of the pubic symphysis; however, ligament strains, compressive and shear stresses in the interpubic disc, as well as posterior bending of the joint structure remained as potential sources of joint damage during automotive side impacts.

Design and validation of a low cost, high-capacity weighing device for wheelchair users and bariatrics.

Accessible high-capacity weighing scales are scarce in healthcare facilities, in part due to high device cost and weight. This shortage impairs weight monitoring and health maintenance for people with disabilities and/or morbid obesity. We conducted this study to design and validate a lighter, lower cost, high-capacity accessible weighing device. A prototype featuring 360 kg (800 lbs) of weight capacity, a wheelchair-accessible ramp, and wireless data transmission was fabricated. Forty-five participants (20 standing, 20 manual wheelchair users, and five power wheelchair users) were weighed using the prototype and a calibrated scale. Participants were surveyed to assess perception of each weighing device and the weighing procedure. Weight measurements between devices demonstrated a strong linear correlation (R2 = 0.997) with absolute differences of 1.4 ± 2.0% (mean±SD). Participant preference ratings showed no difference between devices. The prototype weighed 11 kg (38%) less than the next lightest high-capacity commercial device found by author survey. The prototype's estimated commercial price range, $500-$600, is approximately half the price of the least expensive commercial device found by author survey. Such low cost weighing devices may improve access to weighing instrumentation, which may in turn help eliminate current health disparities. Future work is needed to determine the feasibility of market transition.

Navigation of a virtual exercise environment with Microsoft Kinect by people post-stroke or with cerebral palsy.

One approach to encourage and facilitate exercise is through interaction with virtual environments. The present study assessed the utility of Microsoft Kinect as an interface for choosing between multiple routes within a virtual environment through body gestures and voice commands. The approach was successfully tested on 12 individuals post-stroke and 15 individuals with cerebral palsy (CP). Participants rated their perception of difficulty in completing each gesture using a 5-point Likert scale questionnaire. The "most viable" gestures were defined as those with average success rates of 90% or higher and perception of difficulty ranging between easy and very easy. For those with CP, hand raises, hand extensions, and head nod gestures were found most viable. For those post-stroke, the most viable gestures were torso twists, head nods, as well as hand raises and hand extensions using the less impaired hand. Voice commands containing two syllables were viable (>85% successful) for those post-stroke; however, participants with CP were unable to complete any voice commands with a high success rate. This study demonstrated that Kinect may be useful for persons with mobility impairments to interface with virtual exercise environments, but the effectiveness of the various gestures depends upon the disability of the user.

Increased trabecular bone and improved biomechanics in an osteocalcin-null rat model created by CRISPR/Cas9 technology.

Osteocalcin, also known as bone γ-carboxyglutamate protein (Bglap), is expressed by osteoblasts and is commonly used as a clinical marker of bone turnover. A mouse model of osteocalcin deficiency has implicated osteocalcin as a mediator of changes to the skeleton, endocrine system, reproductive organs and central nervous system. However, differences between mouse and human osteocalcin at both the genome and protein levels have challenged the validity of extrapolating findings from the osteocalcin-deficient mouse model to human disease. The rat osteocalcin (Bglap) gene locus shares greater synteny with that of humans. To further examine the role of osteocalcin in disease, we created a rat model with complete loss of osteocalcin using the CRISPR/Cas9 system. Rat osteocalcin was modified by injection of CRISPR/Cas9 mRNA into the pronuclei of fertilized single cell Sprague-Dawley embryos, and animals were bred to homozygosity and compound heterozygosity for the mutant alleles. Dual-energy X-ray absorptiometry (DXA), glucose tolerance testing (GTT), insulin tolerance testing (ITT), microcomputed tomography (µCT), and a three-point break biomechanical assay were performed on the excised femurs at 5 months of age. Complete loss of osteocalcin resulted in bones with significantly increased trabecular thickness, density and volume. Cortical bone volume and density were not increased in null animals. The bones had improved functional quality as evidenced by an increase in failure load during the biomechanical stress assay. Differences in glucose homeostasis were observed between groups, but there were no differences in body weight or composition. This rat model of complete loss of osteocalcin provides a platform for further understanding the role of osteocalcin in disease, and it is a novel model of increased bone formation with potential utility in osteoporosis and osteoarthritis research.

Contact pressures in the flexed hip joint during lateral trochanteric loading.

Acetabular fractures are an especially problematic outcome of motor vehicle side impacts. While fracture type has been correlated with impact direction and femoral orientation, actual contact pressures in the hip joint have not been quantified for lateral loading conditions. In the present study, we used pressure sensitive film to measure contact areas and pressures in seven hip joints from four cadavers under quasi-static lateral loading through the greater trochanter. The aim was to quantify the interactions of the femoral head with the acetabulum associated with variations in femoral orientation. Three angles of hip flexion (80 degrees , 90 degrees , 100 degrees ) and hip abduction (-10 degrees , 0 degrees , 10 degrees ) were tested, producing nine test orientations for each joint. We observed that contact areas, pressures, and forces varied significantly with femoral orientation for the adducted hip. The principal locations of load transmission were in the anterior and posterior regions of the acetabulum. For the abducted femur, contact pressures were concentrated anteriorly, and with increased adduction, anterior contact pressures diminished while posterior and superior pressures increased. The movement of pressure sites was consistent with mechanisms of acetabular fractures described by Letournel and Judet and provides new data for validation of finite element models of the pelvis in side impact.

A hybrid zinc-calcium-silicate polyalkenoate bone cement.

A novel bone cement composed of sintered zinc-calcium-silicate phosphate and hybrid polyalkenoates has been developed. Synthesis and formulation of glass fillers, monomers and polymers as well as formulation of the cement were described. The effects of sintering, polymer content, glass powder/polymer liquid (P/L) ratio and comonomer on compressive strength (CS) and curing time (CT) were investigated. The effects of P/L ratio and comonomers on shrinkage as well as exotherm were also studied. Results show that the experimental cement was 61% higher in CS, 10% lower in diametral tensile strength, 35% lower in flexural strength, 62% less in exotherm, and 68% less in shrinkage, compared to conventional polymethylmethacrylate cement. With increasing polymer content and P/L ratio in the cement formulation CS of the cement increased but CT decreased. Curing time, shrinkage and exotherm of the cement decreased with increasing P/L ratio. It appears that this novel cement may be a potential candidate for orthopedic restoration if its biological performance is good and formulation is optimized.

Quasi-linear viscoelastic behavior of the human periodontal ligament.

Previous studies have not produced a comprehensive mathematical description of the nonlinear viscoelastic stress-strain behavior of the periodontal ligament (PDL). In the present study, the quasi-linear viscoelastic (QLV) model was applied to mechanical tests of the human PDL. Transverse sections of cadaveric premolars were subjected to relaxation tests and loading to failure perpendicular to the plane of section. Distinct and repeatable toe and linear regions of stress-strain behavior were observed. The amount of strain associated with the toe region differed as a function of anatomical location along the tooth root. Stress relaxation behavior was comparable for different anatomical locations. Model predicted peak tissue stresses for cyclic loading were within 11% of experimental values, demonstrating that the QLV approach provided an improved, accurate quantification of PDL mechanical response. The success of the QLV approach supports its usefulness in future efforts of experimental characterization of PDL mechanical behavior.

Bone mineral density correlates with fracture load in experimental side impacts of the pelvis.

Pelvic fractures resulting from automotive side impacts are associated with high mortality and morbidity, as well as substantial economic costs. Previous experimental studies have produced varying results regarding the tolerance of the pelvis to lateral force and compression. While bone mineral density (BMD) has been shown to correlate with fracture loads in the proximal femur, no such correlation has been established for the pelvis. Presently, we studied the relationships between total hip BMD and impact response parameters in lateral impacts of twelve isolated human pelves. The results indicated that total hip BMD significantly correlated with fracture force, Fmax, and maximum ring compression, Cmax, of the fractured pelves. These findings are evidence that BMD may be useful in assessing the risk of pelvic fracture in automotive side impacts. Poor correlation was observed between total hip BMD and maximum viscous response, (VC)max, energy at fracture, Epeak, and time to fracture, tpeak. Mean Fmax and calculated tolerances for Cmax and (VC)max were lower than those established in previous studies using full cadavers, likely a result of our removal of soft tissues from the pelves prior to impact.

A new cortical thickness mapping method with application to an in vivo finite element model.

Finite element modelling of musculoskeletal systems, with geometrical structures constructed from computed tomography (CT) scans, is a useful and powerful tool for biomechanical studies. The use of CT scans from living human subjects, however, is still limited. Accurate reconstruction of thin cortical bone structures from CT scans of living human subjects is especially problematic, due to low CT resolution that results from mandatory low radiation doses and/or involuntary movements of the subject. In this study, a new method for mapping cortical thickness is described. Using the method, cortical thickness measurements of a coxal (pelvis) bone obtained from CT scans of a cadaver were mapped to the coxal geometry as obtained through CT scans of a live human subject, resulting in accurate cortical thickness while maintaining geometric fidelity of the live subject. The mapping procedure includes shape-preserving parameterisation, mesh movement and interpolation of thickness using a search algorithm. The methodology is applicable to modelling of other bones where accurate cortical thickness is needed and for which such data exist.