OPP003 📄 Overview A SaMD designed as a mobile application that guides patients through personalized post-surgical rehabilitation exercises. It integrates computer vision or depth sensors (e.g., via smartphone/tablet camera) for real-time form correction and progress tracking. Gamification elements, rewards, social support features, and adaptive exercise pathways (based on AI analysis of performance) are used to maximize adherence, improve recovery outcomes, and provide remote monitoring capabilities for physical therapists. Key technologies: 👤 Target users: 👍 Benefits Significantly improved patient adherence to rehabilitation protocols • Faster and more complete recovery post-surgery • Reduced risk of re-injury and complications • Enhanced accessibility to high-quality rehab, especially in rural areas • Reduced burden on physical therapy clinics via remote monitoring Use bullets or new lines. 👎 Challenges Maintaining long-term patient motivation and engagement • Ensuring accuracy of computer vision in diverse home environments • Integration with existing physical therapy electronic health records • Demonstrating equivalence or superiority to in-person therapy for reimbursement • Addressing digital literacy and access for all patient demographics 📋 Regulatory & Validation Likely Class II SaMD as it provides therapeutic guidance and monitoring. • Requires clinical validation trials to prove effectiveness in improving rehabilitation outcomes. • Clear safety considerations, including guidance for when to seek immediate medical attention. • Cybersecurity for patient data and secure communication channels are mandatory.