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

Video Transcription

Video Summary

Dr. Nicholas Patrick from the FDA discusses regulations for platform-based suites in AI and technology in this video presentation. He explains that medical devices are categorized into different classes, ranging from class 1 to class 3, with increasing regulatory controls. Class 1 devices are low-risk and exempt from data requirements, while class 2 devices, including endoscopes, require a 510K pre-market notification to demonstrate substantial equivalence to a predicate device. Class 3 devices, the highest risk devices, must demonstrate reasonable assurance of safety and effectiveness. Dr. Patrick focuses specifically on CADx devices for endoscopy, highlighting the need for clinical testing and non-clinical testing, such as standalone algorithm performance testing. He also emphasizes the importance of matching patient populations in clinical studies and considering compatibility for AI devices with different acquisition systems. Dr. Patrick provides examples of AI applications in endoscopy, such as computer-aided detection and computer-aided diagnosis, and mentions the potential for AI to assist clinicians in improving data acquisition. He explains the study designs for clinical testing, including multi-reader, multi-case studies, and outlines statistical analysis methods. In addition, he discusses performance evaluation parameters for standalone testing, such as object-based and frame-based assessments.

Asset Subtitle

Nicholas Petrick, PhD

Keywords

FDA regulations

platform-based suites

medical devices

CADx devices

clinical testing