Beyond the 510(k): The regulation of novel moderate-risk medical devices, intellectual property considerations, and innovation incentives in the FDA's De Novo pathway.

Moderate-risk medical devices constitute 99% of those that have been regulated by the U.S. Food and Drug Administration (FDA) since it gained authority to regulate medical technology nearly five decades ago. This article presents an analysis of the interaction between the 510(k) process -the historically dominant path to market for most medical devices- and the De Novo pathway, a more recent alternative that targets more novel devices, including those involving new technologies, diagnostics, hardware, and software. The De Novo pathway holds significant potential for innovators seeking to define new categories of medical devices, as it represents a less burdensome approach than would have otherwise been needed historically. Moreover, it supports the FDA in its effort to modernize the long-established 510(k) pathway by promoting the availability of up-to-date device "predicates" upon which subsequent device applications can be based, reflecting positive spillovers that are likely to encourage manufacturers to adopt current state-of-the-art technologies and modern standards of safety and effectiveness. We analyze the of characteristics all the De Novo classification requests to date, including the submission type, trends, FDA review times, and device types. After characterizing how the De Novo process has been used over time, we discuss its unique challenges and opportunities with respect to medical device software and AI-enabled devices, including considerations for intellectual property, innovation, and competition economics.

New Plastic Crack-Tip Opening Displacement Tool Based on Digital Image Correlation for Estimating the Fatigue-Crack-Growth Law on 316L Stainless Steel.

This work presents a new approach for studying crack growth resulting from fatigue, which utilizes the plastic contribution of crack-tip opening displacement (CTODp). CTODp is used to predict austenitic stainless-steel crack propagation. Unlike linear elastic fracture mechanics analysis, the method presented here is also helpful for tasks other than small-scale yielding. The approach was based on correlating full-field displacement information with post-processing digital images. This work describes a detailed post-processing protocol that can be used to calculate CTODp. The results for steel compact-tension specimens were especially promising. Of note, there was a linear relationship between the propagation rate of fatigue cracks and the CTODp range.

Therapeutic Approaches in Lysosomal Storage Diseases.

Lysosomal Storage Diseases are multisystemic disorders determined by genetic variants, which affect the proteins involved in lysosomal function and cellular metabolism. Different therapeutic approaches, which are based on the physiologic mechanisms that regulate lysosomal function, have been proposed for these diseases. Currently, enzyme replacement therapy, gene therapy, or small molecules have been approved or are under clinical development to treat lysosomal storage disorders. The present article reviews the main therapeutic strategies that have been proposed so far, highlighting possible limitations and future perspectives.

Estimation of the Plastic Zone in Fatigue via Micro-Indentation.

Accurate knowledge of the plastic zone of fatigue cracks is a very direct and effective way to quantify the damage of components subjected to cyclic loads. In this work, we propose an ultra-fine experimental characterisation of the plastic zone based on Vickers micro-indentations. The methodology is applied to different compact tension (CT) specimens made of aluminium alloy 2024-T351 subjected to increasing stress intensity factors. The experimental work and sensitivity analysis showed that polishing the surface to #3 µm surface finish and applying a 25 g-force load for 15 s produced the best results in terms of resolution and quality of the data. The methodology allowed the size and shape of both the cyclic and the monotonic plastic zones to be visualised through 2D contour maps. Comparison with Westergaard's analytical model indicates that the methodology, in general, overestimates the plastic zone. Comparison with S355 low carbon steel suggests that the methodology works best for alloys exhibiting a high strain hardening ratio.

Study of Recycling Potential of FFP2 Face Masks and Characterization of the Plastic Mix-Material Obtained. A Way of Reducing Waste in Times of Covid-19.

The purpose of this study is to investigate how to recycle FFP2 face masks used during Covid-19 pandemic without using previous sorting process and to characterize the properties of the material obtained. The way of splitting and processing the mixture of materials was studied as well as the final properties such as chemical, thermal and mechanical characteristics. The resulting recycled material is a blend of polymers with such mechanical and thermal properties that could be used as an alternative to recycled PP (polypropylene). Avoidance of previous sorting process gives the face mask recycling a new and simplified way of preventing this material to be disposed in environment and an opportunity of second life for the polymers they are made of. With this work we lay the basis to reduce the plastic pollution related with the recommended use of face masks during Covid-19 pandemic.

Vertical Dimension of Occlusion: A comparative study between Anthropometric and Knebelman's craniometric methods.

The masticatory system changes as time passes. The vertical dimension of occlusion (VDO) undergoes alterations due to temporomandibular joint disorders which in turn may be caused by related muscle modifications or pathological tooth wear. There are many methods to measure VDO. Among these, the anthropometric method and Knebelman's craniometric method have been shown to be the most closely related to facial biotype. The aim of this study was to compare data recorded with those two methods. A descriptive cross-sectional study was performed with a total 200 patients. A vernier caliper was used to measure facial landmarks. Results were analyzed using paired t-test, setting the level of significance at p<0.05. There was no significant difference between the two methods but Knebelman's method had less variability. Results suggest that Knebelman's method should provide more reliability for determining VDO in all the facial biotypes studied.

El sistema masticatorio cambia con el paso del tiempo. La dimensión vertical oclusal sufre alteraciones que se atribuyen a trastornos temporomandibulares a su vez causados por modificaciones en la musculatura relacionada o al desgaste patológico de las piezas dentarias. Existen muchos métodos para medir la dimensión vertical, entre los cuales el método antropométrico y el método craneométrico de Knebelman mostraron ser los más vinculados con el biotipo facial. El objetivo de este estudio fue comparar datos registrados con ambos métodos. La comparación fue realizada mediante un estudio de diseño transversal descriptivo con un total de 200 pacientes, usando un calibrador vernier para realizar mediciones entre puntos faciales establecidos. Los resultados fueron analizados por medio de la prueba de t de Student para datos emparejados estableciendo el nivel de significación en P<0,05. No se encontró diferencia significativa entre los métodos, pero el método de Knebelman mostró generar menos variabilidad en sus medidas. Este último método parece proporcionar más confiabilidad para su aplicación en la determinación de la dimensión vertical oclusal en todos los biotipos faciales estudiados.

Vertical Dimension of Occlusion: A comparative study between Anthropometric and Knebelman's craniometric methods / Dimensión vertical oclusal: un estudio comparativo entre el método antropométrico y el método craneométrico de Knebelman

ABSTRACT The masticatory system changes as time passes. The vertical dimension of occlusion (VDO) undergoes alterations due to temporomandibular joint disorders which in turn may be caused by related muscle modifications or pathological tooth wear. There are many methods to measure VDO. Among these, the anthropometric method and Knebelman's craniometric method have been shown to be the most closely related to facial biotype. The aim of this study was to compare data recorded with those two methods. A descriptive cross-sectional study was performed with a total 200 patients. A vernier caliper was used to measure facial landmarks. Results were analyzed using paired t-test, setting the level of significance at p<0.05. There was no significant difference between the two methods but Knebelman's method had less variability. Results suggest that Knebelman's method should provide more reliability for determining VDO in all the facial biotypes studied.

RESUMEN El sistema masticatorio cambia con el paso del tiempo. La dimensión vertical oclusal sufre alteraciones que se atribuyen a trastornos temporomandibulares a su vez causados por modificaciones en la musculatura relacionada o al desgaste patológico de las piezas dentarias. Existen muchos métodos para medir la dimensión vertical, entre los cuales el método antropométrico y el método craneométrico de Knebelman mostraron ser los más vinculados con el biotipo facial. El objetivo de este estudio fue comparar datos registrados con ambos métodos. La comparación fue realizada mediante un estudio de diseño transversal descriptivo con un total de 200 pacientes, usando un calibrador vernier para realizar mediciones entre puntos faciales establecidos. Los resultados fueron analizados por medio de la prueba de t de Student para datos emparejados estableciendo el nivel de significación en P<0,05. No se encontró diferencia significativa entre los métodos, pero el método de Knebelman mostró generar menos variabilidad en sus medidas. Este último método parece proporcionar más confiabilidad para su aplicación en la determinación de la dimensión vertical oclusal en todos los biotipos faciales estudiados.

Una respuesta ética en la atención a residencias de ancianos en la pandemia Covid-19 / An ethical response in the care of nursing homes in the covid-19 pandemic

La llegada de la pandemia COVID-19 puso en evidencia el riesgo de una posible falta de atención de los ancianos de las residencias de mayores. Aportamos la experiencia de un equipo multidisciplinar con profesionales voluntarios de diferentes especialidades que realizó una labor de apoyo a los profesionales sanitarios de las residencias. Este equipo se implementó desde las gerencias de atención primaria y de atención especializada. La sistemática de trabajo se inspiraba en el de hospitalización a domicilio e incluía la atención directa de los pacientes más complejos y el asesoramiento en las medidas de prevención, aislamiento e higiene dentro de la residencia. De este modo fue posible que los ancianos de las residencias con sospecha o diagnóstico de COVID-19 recibieran una atención adecuada por parte de un equipo interdisciplinar, que se descargara parte de la presión de los profesionales de las residencias y que los familiares percibieran que no existía abandono terapéutico. El compromiso desde diversos niveles asistenciales en una labor coordinada ha conseguido evitar que una población vulnerable pudiera quedar desatendido durante la pandemia

With the arrival of the COVID-19 pandemic, the risk of a possible lack of care for the elderly in nursing homes became evident. We summarize the experience of a multidisciplinary team with volunteer professionals from different specialties who carried out support for healthcare professionals in nursing homes. This team was implemented from both Primary and Specialty Care managements. Its work paradigm was proposed by our home hospitalization team, which included direct care of the most complex patients and general counselling on isolation, hygiene and preventive measures within the nursing homes. Thanks to this support, the elderly population placed there, with suspected or diagnosed COVID-19, received adequate care from an interdisciplinary team, which led part of the pressure to be released from their professional workers, and many family members were aware that there was no neglect of the elderly. Commitment from various levels of care in a coordinated effort has prevented a vulnerable population from being left unattended during the pandemic

Aspectos socio demográficos y calidad de vida en salud Bucal, del personal del municipio de Azogues - Ecuador / Socio-demographic aspects and quality of life in oral health of the staff of the municipality of Azogues - Ecuador

Objetivo: Asociar los aspectos socio demográficos y la calidad de vida en salud bucal del personal del Municipio de Azogues - Ecuador. Material y métodos: La presente constituye una investigación transversal, descriptiva, observacional misma que investigó a 185 adultos, aplicándoles una encuesta para determinar aspectos relacionadas a datos personales, determinantes sociales y uso de servicio odontológico. Seguido se indagó sobre el impacto de la salud bucal en la calidad de vida utilizando el cuestionario validado Ohip -14Sp. Se efectúo análisis univariado y bivariado. Para el estudio bivariado se utilizó el Odds Ratio (OR) para asociar los factores mencionados con la calidad de vida relacionada a la salud bucal (CVRSB). Se contó con un nivel de confianza del 95% y un p<0,05. Resultados: No se encontró asociación estadísticamente significativa al evaluar todas las variables con CVRSB; el grupo con la mayor prevalencia de impactos según el nivel de instrucción fueron Universitarios con un 46%; según el ingreso mensual, los de ingreso mensual menor a $1000 con un 66%; de acuerdo a la denominación laboral los trabajadores con un 53%; de acuerdo al motivo de consulta, fueron otras causas 39%. Sin embargo, a pesar de que no hay una asociación significativa, se puede apreciar que el sexo masculino fue el más impactado. Conclusiones: Las determinantes sociales y CVRSB no estuvieron asociados. Las dimensiones limitación funcional, dolor físico y obstáculos fueron las más frecuentes.

Objective: To associate the socio-demographic aspects and the quality of life in oral health of the personnel of the Municipality of Azogues - Ecuador. Material and methods: This is a transversal, descriptive, observational research that investigated 185 adults, applying a survey to determine aspects related to personal data, social determinants and use of dental service. Afterwards, the impact of oral health on the quality of life was investigated using the Ohip-14Sp validated questionnaire. Univariate and bivariate analyzes were carried out. For the bivariate study, the Odds Ratio (OR) was used to associate the aforementioned factors with the quality of life related to oral health (HRQOL). There was a confidence level of 95% and p <0.05. Results: No statistically significant association was found when evaluating all variables with CVRSB; The group with the highest prevalence of impacts according to the level of education were University students with 46%; according to the monthly income, the monthly income less than $ 1000 with 66%, according to the labor denomination the workers with 53%; according to the reason for consultation, other causes were 39%. However, although there is no significant association, it can be seen that the male sex was the most impacted. Conclusions: The social determinants and CVRSB were not associated. The dimensions of functional limitation, physical pain and obstacles were the most frequent.

Need for orthodontic treatment in a sample of Ecuadorian adolescents from Cojitambo, 2017

Aim: To determine the need for orthodontic treatment in Ecuadorian adolescents aged 13 to 18 years in Cojitambo, 2017. Materials and methods: A cross-sectional and descriptive study was made including 140 adolescents aged 13 to 18 years, 50% males. For determining the prevalence of malocclusion, a visual clinical examination was performed to obtain the data required using the Dental Aesthetic Index (DAI). Results: 37.14% of the adolescents presented a minor malocclusion (without the need for treatment), 20% a definitivemalocclusion (need for elective treatment), 30% a severe malocclusion (highly desirable treatment) and 12.86% a very severe malocclusion (mandatory treatment). No statistically significant differences were found by sex (p =0.53) or by age (p =0.05). Conclusion: There is a higher prevalence of adolescents who had a normal occlusion without the need of orthodontic treatment and the ones with the lowest prevalence were adolescents with very severe malocclusion that needed compulsory treatment, without differences by sex or age

Dental anxiety in the municipal personnnel of Biblián, Ecuador, 2018

The aim of this study was to determine the degree of dental anxiety in the staff of the Municipality of Biblián, Ecuador. A cross-sectional study was carried out using the modified Corah dental anxiety scale in its Spanish version. A total of 159 employees, 72.3% men and 27.7% women, were included. The most prevalent level of dental anxiety was mild or none (37.1%), followed by moderate anxiety (35.6%), and severe anxiety or phobia (13.8%). The most prevalent degree of anxiety in men was mild or null (28.9%), and in women this was moderate at 8.8%. In relation to age, the group aged 31 to 50 years had the highest prevalence of severe dental anxiety or phobia (9.4%). The staff of the Municipality of Biblián presented a high prevalence of mild or no anxiety

Impact of dental self-perception on the quality of life of students at the Catholic University of Cuenca, Azogues in 2018

Dental aesthetics is an important factor since it represents a determinant and influential physical stereotype on the individual in different age groups. Young people are particularly vulnerable due to the influence of social media. Thus, there is a greater collective interest in improving the appearance of their smiles, allowing them to improve their interpersonal relationships. Currently, there are several indices to assess quality of life and dental aesthetics. The aim of this study was to evaluate the impact of dental self-perception on the quality of life of students at the Catholic University of Cuenca, Azogues, in 2018. The study included a sample of 189 students; the Aesthetic Oral Health Impact Profile (A-OHIP14) questionnaire was applied. Inferential statistics used chi-squared tests (p<0.05). No statistical significance was found between quality of life according to sex (p=0.246) or age (p=0.132). Regarding the domains, it was reported that psychological discomfort and physical pain has the highest scores (3.15-2.92), while they feeling disadvantaged and social disability had lower scores (1.5-1.56). Male students aged 18 to 21 showed the greatest impact of dental self-perception on quality of life associated with oral health.

Oral-health knowledge of Ecuadorian pregnant women

The aim of this study is to determine the level of knowledge in oral health of pregnant women who come to the Comprehensive Medical Center and Geriatric Gerontium of the IESS in Azogues-Ecuador. A cross-sectional study was carried out on 109 pregnant women from the first to the third trimester of pregnancy. A questionnaire was used to collect data, which was validated in the study by Castro et al. in Peru. The first part of the questionnaire includes questions of socio-demographic order, such as the trimester of pregnancy, level of education, urban or rural origin, and age. The second part includes 22 questions to assess the level of knowledge in various topics in oral health, such as preventive measures, understanding of oral diseases, dental care, and dental development. The responses to the second part were evaluated according to a numerical scale: 0 to 6 points were bad, 7 to 14 points were regular, and 15 to 22 points were good. The statistical analysis consisted of absolute and relative frequencies of the qualitative variables. A bivariate analysis was performed using the Chi Square test with a significance level of p <0.05. The knowledge in oral health of pregnant women was regular, reaching 82.56% in overall, 56.88% in preventive measures, 64.22% in understanding of oral diseases, 61.46% in dental care during pregnancy, and 60.55% in dental development. No differences were detected in the levels of knowledge according to the trimester of pregnancy (p = 0.38), educational level (p = 0.91), urban or rural origin (p = 0.25), or age (p = 0.98). The level of knowledge of oral health of pregnant women attending the Integral Geriatric Medical Center and Geronto IESS in Azogues-Ecuador is regular and is not associated with socio-demographic factors.