Gastroenterology and Artificial Intelligence: 4th Annual Global Artificial Intelligence Summit (On-Demand | August 2022-Regulations for Platform-based “Suites of AI Technology"

Video Transcription

Video Summary

Dr. Nicholas Patrick from the FDA discusses the regulations for platform-based suites in AI and technology in this video summary. He explains that medical devices are categorized from class 1 to class 3, with regulatory controls increasing from class 1 to class 3. Class 1 devices are low-risk and exempt from data requirements, while class 2 devices, such as endoscopes, require a pre-market notification or be substantially equivalent to a predicate device. Class 3 devices need to demonstrate reasonable assurance of safety and effectiveness. Dr. Patrick mentions the Gastrointestinal Lesion Software Detection System as an AI device in endoscopy that has been cleared under the de novo process. He also discusses the importance of clinical testing and standalone algorithm performance testing in assessing the effectiveness of AI algorithms. Dr. Patrick emphasizes the need for consistent numbers of cases across clinicians and matching patient populations in studies. He highlights the importance of benchmarking algorithm performance, considering variations in image acquisition and understanding the clinical relevance and usability of AI devices for endoscopy. This video was presented by Dr. Nicholas Patrick from the FDA.

Asset Subtitle

Nicholas Petrick, PhD

Keywords

FDA regulations

platform-based suites

AI technology

medical devices

class categorization