The Alliance provided its wound care perspective in response to the FDA's Request For Public Comment: Measuring and Evaluating Artificial Intelligence-enabled Medical Device Performance in the Real-World. The Alliance addressed both the transformative benefits of AI in wound care like automating wound image segmentation, measuring wound area and depth, and predicting healing trajectories, but emphasized that AI technologies should support and aid clinical decision-making, not replace it. Clinicians provide contextual interpretation, ensure outputs are clinically meaningful, and manage ambiguous scenarios that fall outside an algorithm’s learned patterns. Clinician review also serves as a critical safeguard for ethical decision-making and patient safety, the Alliance wrote, noting that the most effective real-world workflows should integrate both modalities. Read the Alliance's specific responses to questions posed by FDA in the comments below (accessible with member login). 

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