ASGE Annual Postgraduate Course: Clinical Challenges and Real-Time Decision Making in GI Endoscopy (Live and Virtual) | May 2023-Regulations for Platform-based “Suites of AI Technology"

Video Transcription

Video Summary

The video features Dr. Nicholas Patrick from the FDA discussing regulations for platform-based suites in AI and technology, specifically focusing on regulating CADx devices for endoscopy. Dr. Patrick explains how medical devices are classified into different categories (class 1 to class 3) based on regulatory controls and the associated data requirements. Class 1 devices are low-risk and exempt from data requirements, while class 2 devices, including endoscopes, require a submission demonstrating substantial equivalence to an existing device. Class 3 devices, the highest risk, need to demonstrate safety and effectiveness independently. Dr. Patrick highlights the importance of clinical testing, including multi-reader, multi-case studies, to account for clinician variability. He also discusses the significance of standalone performance testing to benchmark algorithm performance and facilitate generalizability analysis. The video concludes with a summary of different categories of AI in endoscopy and the importance of considering acquisition compatibility and patient demographic in performance evaluations.<br /><br />No credits granted.

Asset Subtitle

Nicholas Petrick, PhD

Keywords

FDA

regulations

CADx devices

endoscopy

clinical testing