PROACTIVE-AI: An Intelligent Dashboard for Assessing and Predicting of FDA-approved AI Software Performance in Real-World Clinical Scenarios

Abstract

Recent years have witnessed a surge in FDA approved AI tools for healthcare applications. While this growth offers considerable potential benefits for clinical practice, it also introduces substantial challenges related to ethics, regulation, and patient safety. These challenges are further compounded by previously documented gaps in the regulatory approval pathway. These gaps include inconsistent pre-market evaluation practices, over-reliance on retrospective studies, and the limited systematic post-market surveillance of AI devices in real-world clinical settings. Using publicly available FDA data, we developed therefore an interactive web-based dashboard for assessing and predicting the performance of FDA-approved AI software, called PROACTIVE-AI, for the purpose of pro-viding the user with a structured guidance on the anticipated performance of AI-enabled medical devices in real-world clinical settings. The dashboard supports exploratory analysis by diverse stakeholders via knowledge graph visualization and longitudinal trend monitoring of performance indicators, including device recalls and safety-related issues. In addition, PROACTIVE-AI incorporates an AI-aided post-market surveillance risk assessment calculator, derived from historical recall data, to identify device characteristics and con-textual factors associated with elevated deployment risk. Our findings using the PROACTIVE-AI dashboard highlight some of the important challenges related to real-world monitoring and accountability of deployed AI medical devices. Furthermore, it illustrates the potential value of such dashboard in narrowing the trust gap surrounding AI in healthcare by providing quantitative metrics of expected clinical performance and recall-related risk factors.