Methodology for Conducting Post-Marketing Surveillance of Software as a Medical Device Based on Artificial Intelligence Technologies.

The aim of the study was to develop a methodology for conducting post-registration clinical monitoring of software as a medical device based on artificial intelligence technologies (SaMD-AI). Materials and Methods: The methodology of post-registration clinical monitoring is based on the requirements of regulatory legal acts issued by the Board of the Eurasian Economic Commission. To comply with these requirements, the monitoring involves submission of the review of adverse events reports, the review of developers' routine reports on the safety and efficiency of SaMD-AI, and the assessment of the system for collecting and analyzing developers' post-registration data on the safety and efficiency of medical devices. The methodology was developed with regard to the recommendations of the International Medical Device Regulators Forum and the documents issued by the Food and Drug Administration (USA). Field-testing of this methodology was carried out using SaMD-AI designed for diagnostic imaging. Results: The post-registration monitoring of SaMD-AI consists of three key stages: collecting user feedback, technical monitoring and clinical validation. Technical monitoring involves routine evaluation of SaMD-AI output data quality to detect and remove flaws in a timely manner, and to secure the product stability. Major outcomes include an ordered list of technical flaws in SaMD-AI and their classification using evidence from diagnostic imaging studies. The application of this methodology resulted in a gradual reduction in the number of studies with flaws due to timely improvements in artificial intelligence algorithms: the number of flaws decreased to 5% in various aspects during subsequent testing. Clinical validation confirmed that SaMD-AI is capable of producing clinically meaningful outputs related to its intended use within the functionality determined by the developer. The testing procedure and the baseline testing framework were established during the field testing. Conclusion: The developed methodology will ensure the safety and efficiency of SaMD-AI taking into account its specifics as intangible medical devices. The methodology presented in this paper can be used by SaMD-AI developers to plan and carry out the post-registration clinical monitoring.

A simplified cluster model and a tool adapted for collaborative labeling of lung cancer CT scans.

BACKGROUND AND OBJECTIVE: Lung cancer is the most common type of cancer with a high mortality rate. Early detection using medical imaging is critically important for the long-term survival of the patients. Computer-aided diagnosis (CAD) tools can potentially reduce the number of incorrect interpretations of medical image data by radiologists. Datasets with adequate sample size, annotation, and truth are the dominant factors in developing and training effective CAD algorithms. The objective of this study was to produce a practical approach and a tool for the creation of medical image datasets. METHODS: The proposed model uses the modified maximum transverse diameter approach to mark a putative lung nodule. The modification involves the possibility to use a set of overlapping spheres of appropriate size to approximate the shape of the nodule. The algorithm embedded in the model also groups the marks made by different readers for the same lesion. We used the data of 536 randomly selected patients of Moscow outpatient clinics to create a dataset of standard-dose chest computed tomography (CT) scans utilizing the double-reading approach with arbitration. Six volunteer radiologists independently produced a report for each scan using the proposed model with the main focus on the detection of lesions with sizes ranging from 3 to 30 mm. After this, an arbitrator reviewed their marks and annotations. RESULTS: The maximum transverse diameter approach outperformed the alternative methods (3D box, ellipsoid, and complete outline construction) in a study of 10,000 computer-generated tumor models of different shapes in terms of accuracy and speed of nodule shape approximation. The markup and annotation of the CTLungCa-500 dataset revealed 72 studies containing no lung nodules. The remaining 464 CT scans contained 3151 lesions marked by at least one radiologist: 56%, 14%, and 29% of the lesions were malignant, benign, and non-nodular, respectively. 2887 lesions have the target size of 3-30 mm. Only 70 nodules were uniformly identified by all the six readers. An increase in the number of independent readers providing CT scans interpretations led to an accuracy increase associated with a decrease in agreement. The dataset markup process took three working weeks. CONCLUSIONS: The developed cluster model simplifies the collaborative and crowdsourced creation of image repositories and makes it time-efficient. Our proof-of-concept dataset provides a valuable source of annotated medical imaging data for training CAD algorithms aimed at early detection of lung nodules. The tool and the dataset are publicly available at https://github.com/Center-of-Diagnostics-and-Telemedicine/FAnTom.git and https://mosmed.ai/en/datasets/ct_lungcancer_500/, respectively.

Chest MRI of patients with COVID-19.

During the pandemic of novel coronavirus infection (COVID-19), computed tomography (CT) showed its effectiveness in diagnosis of coronavirus infection. However, ionizing radiation during CT studies causes concern for patients who require dynamic observation, as well as for examination of children and young people. For this retrospective study, we included 15 suspected for COVID-19 patients who were hospitalized in April 2020, Russia. There were 4 adults with positive polymerase chain reaction (PCR) test for COVID-19. All patients underwent magnetic resonance imaging (MRI) examinations using MR-LUND PROTOCOL: Single-shot Fast Spin Echo (SSFSE), LAVA 3D and IDEAL 3D, Echo-planar imaging (EPI) diffusion-weighted imaging (DWI) and Fast Spin Echo (FSE) T2 weighted imaging (T2WI). On T2WI changes were identified in 9 (60,0%) patients, on DWI - in 5 (33,3%) patients. In 5 (33,3%) patients lesions of the parenchyma were visualized on T2WI and DWI simultaneously. At the same time, 4 (26.7%) patients had changes in lung tissue only on T2WI. (P(McNemar) = 0,125; OR = 0,00 (95%); kappa = 0,500). In those patients who had CT scan, the changes were comparable to MRI. The results showed that in case of CT is not available, it is advisable to conduct a chest MRI for patients with suspected or confirmed COVID-19. Considering that T2WI is a fluid-sensitive sequence, if imaging for the lung infiltration is required, we can recommend the abbreviated MRI protocol consisting of T2 and T1 WI. These data may be applicable for interpreting other studies, such as thoracic spine MRI, detecting signs of viral pneumonia of asymptomatic patients. MRI can detect features of viral pneumonia.

[State and prospects of legal regulation of telemedicine consultation in the patient-specialist format in children's psychiatric practice]. / Sostoyanie normativno-pravovogo regulirovaniya telemeditsinskogo konsul'tirovaniya i ego sovershenstvovanie v formate «patsient ­ spetsialist¼ v detskoi psikhiatricheskoi praktike.

INTRODUCTION: Remote interaction of medical workers with patients and (or) their legal representatives (the patient-doctor model) contains a large number of unresolved organizational and legal issues. OBJECTIVE: Analysis of the peculiarities of the organization and legal regulation of telemedicine counseling in child psychiatric practice and the development of recommendations for improving the legal and regulatory framework for remote interaction in the patient-specialist format. MATERIAL AND METHODS: The article analyzes the legal and regulatory requirements governing the use of telemedicine technologies in the process of providing psychiatric care. The material for the analysis was the experience of 1129 telemedicine consultations (TMC) in the patient-doctor model in the period from December 2019 to July 2020. RESULTS: Proposals have been formulated to improve the regulatory framework for TMC in psychiatric practice: consideration of the possibility of remote psychiatric examination within the framework of primary TMC; conducting remote medical commissions; elimination of conflicting regulatory requirements governing primary TMC. CONCLUSION: Conducting repeated TMC seems to be optimal as an effective tool for improving the quality and availability of medical care.

[Artificial intelligence for diagnosis of vertebral compression fractures using a morphometric analysis model, based on convolutional neural networks].

BACKGROUND: Pathological low-energy (LE) vertebral compression fractures (VFs) are common complications of osteoporosis and predictors of subsequent LE fractures. In 84% of cases, VFs are not reported on chest CT (CCT), which calls for the development of an artificial intelligence-based (AI) assistant that would help radiology specialists to improve the diagnosis of osteoporosis complications and prevent new LE fractures. AIMS: To develop an AI model for automated diagnosis of compression fractures of the thoracic spine based on chest CT images. MATERIALS AND METHODS: Between September 2019 and May 2020 the authors performed a retrospective sampling study of ССТ images. The 160 of results were selected and anonymized. The data was labeled by seven readers. Using the morphometric analysis, the investigators received the following metric data: ventral, medial and dorsal dimensions. This was followed by a semiquantitative assessment of VFs degree. The data was used to develop the Comprise-G AI mode based on CNN, which subsequently measured the size of the vertebral bodies and then calculates the compression degree. The model was evaluated with the ROC curve analysis and by calculating sensitivity and specificity values. RESULTS: Formed data consist of 160 patients (a training group - 100 patients; a test group - 60 patients). The total of 2,066 vertebrae was annotated. When detecting Grade 2 and 3 maximum VFs in patients the Comprise-G model demonstrated sensitivity - 90,7%, specificity - 90,7%, AUC ROC - 0.974 on the 5-FOLD cross-validation data of the training dataset; on the test data - sensitivity - 83,2%, specificity - 90,0%, AUC ROC - 0.956; in vertebrae demonstrated sensitivity - 91,5%, specificity - 95,2%, AUC ROC - 0.981 on the cross-validation data; for the test data sensitivity - 79,3%, specificity - 98,7%, AUC ROC - 0.978. CONCLUSIONS: The Comprise-G model demonstrated high diagnostic capabilities in detecting the VFs on CCT images and can be recommended for further validation.