Browsing by Author "Pinto, Joana F."
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- Feasibility of 3D body tracking from monocular 2D video feeds in musculoskeletal telerehabilitationPublication . Clemente, Carolina; Chambel, Gonçalo; Silva, Diogo C. F.; Montes, António Mesquita; Pinto, Joana F.; Silva, Hugo Plácido da; Mesquita Montes, António; Silva, Diogo C. F.Musculoskeletal conditions affect millions of people globally; however, conventional treatments pose challenges concerning price, accessibility, and convenience. Many telerehabilitation solutions offer an engaging alternative but rely on complex hardware for body tracking. This work explores the feasibility of a model for 3D Human Pose Estimation (HPE) from monocular 2D videos (MediaPipe Pose) in a physiotherapy context, by comparing its performance to ground truth measurements. MediaPipe Pose was investigated in eight exercises typically performed in musculoskeletal physiotherapy sessions, where the Range of Motion (ROM) of the human joints was the evaluated parameter. This model showed the best performance for shoulder abduction, shoulder press, elbow flexion, and squat exercises. Results have shown a MAPE ranging between 14.9% and 25.0%, Pearson’s coefficient ranging between 0.963 and 0.996, and cosine similarity ranging between 0.987 and 0.999. Some exercises (e.g., seated knee extension and shoulder flexion) posed challenges due to unusual poses, occlusions, and depth ambiguities, possibly related to a lack of training data. This study demonstrates the potential of HPE from monocular 2D videos, as a markerless, affordable, and accessible solution for musculoskeletal telerehabilitation approaches. Future work should focus on exploring variations of the 3D HPE models trained on physiotherapy-related datasets, such as the Fit3D dataset, and post-preprocessing techniques to enhance the model’s performance.
- Preparing the certification of software as a medical device: a european regulatory analysis and case study on the Clynx®PlatformPublication . Mesquita Montes, António; Pinto, Joana F.; Silva, Hugo P. da; Chambel, Gonçalo; Clemente, Carolina; Silva, Diogo C. F.; Montes, António M.; Simões, Daniela; Silva, Diogo C. F.The primary objective of this study is the preparation of the certification of the Clynx® Platform, a physiotherapy software, as a Class IIa medical device software in accordance with the regulatory framework outlined in Medical Device Regulation 2017/745 (MDR). The methodology involves a comprehensive analysis of European Union medical device regulations and guidelines, with a specific focus on the certification process essential for obtaining a Conformité Européenne (CE) marking for Class IIa medical device software. This section explores the intricate aspects of the certification process, emphasizing the compilation of Technical Documentation, the nuances of Clinical Evaluation, and the establishment of a Quality Management System. The approach aligns closely with the stipulations of MDR 2017/745. The study includes an industry case study featuring the Clynx® Platform, developed by Clynx® Health. Insights derived from the MDR are applied to categorize an in-development version of the software as a Class IIa medical device. The preparation of certification of this product involves the meticulous creation of Intended Use, Classification, General and Safety Performance Requirements, and Clinical Evaluation files, the presentation of an experimental protocol to validate the software’s technical performance for inclusion in the Clinical Evaluation, and a description of an Internal Audit performed on the Quality Management System. The certification of Class IIa medical device software necessitates the compilation of thorough Technical Documentation, including an extensive Clinical Evaluation, and the implementation of a robust Quality Management System. The certification process is conducted in collaboration with Notified Bodies, ensuring adherence to the stringent requirements set forth by the regulatory framework.