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This paper describes current issues regarding regulatory requirements in medical devices with a focus on data-driven / AI based approaches. It shows that the EU Medical Device Regulation (MDR) sets high requirements to assess product performance based on systematically collected data, whereas the collection of data is difficult in the EU. Contrary, it demonstrates that the FDA is currently very active in supporting the development of software based systems in the US with dedicated regulatory programs. In particular, it pursues more dynamic approaches for releasing software devices. The overall situation favors developments in the US. Thus, the paper surveys a program to support local entities on adapting AI technologies.
Validation of Continuously Learning AI/ML Systems in Medical Devices – A Scenario-based Analysis
(2020)
Vertebral motion reveals complex patterns, which are not yet understood in detail. This applies to vertebral kinematics in general but also to specific motion tasks like gait. For gait analysis, most of existing publications focus on averaging characteristics of recorded motion signals. Instead, this paper aims at analyzing intra- and inter-individual variation specifically and elaborating motion parameters, which are consistent during gait cycles of particular persons. For this purpose, a study design was utilized, which collected motion data from 11 asymptomatic test persons walking at different speed levels (2, 3, and 4 km/h). Acquisition of data was performed using surface topography. The motion signals were preprocessed in order to separate average vertebral orientations (neutral profiles) from basic gait cycles. Subsequently, a k-means clustering technique was applied to figure out, whether a discrimination of test persons was possible based on the preprocessed motion signals. The paper shows that each test sequence could be assigned to the particular test person without additional prior information. In particular, the neutral profiles appeared to be highly consistent intra-individually (across the gait cycles as well as speed levels), but substantially different between test persons. A full discrimination of test persons was achieved using the neutral profiles with respect to flexion/extension data. Based on this, these signals can be considered as individual characteristics for the particular test persons.
Keywords: Gait analysis; Human spine; Intra- and interindividual variation; Motion analysis; Rasterstereography; Surface topography; k-means algorithm.