GI Genius is an artificial intelligence-based software device designed to assist endoscopists during colonoscopy. It analyzes live video images from standard white-light endoscopy in real time and highlights abnormal colonic mucosal lesions such as polyps and adenomas to aid detection. By providing visual markers on the video display, it helps clinicians identify lesions that might be missed, improving detection rates and supporting clinical decision making.
Intended Use
The GI Genius System is a computer-assisted reading tool designed to aid endoscopists in detecting colonic mucosal lesions (such as polyps and adenomas) in real time during standard white-light endoscopy examinations of patients undergoing screening and surveillance endoscopic mucosal evaluations. The device is limited for use with standard white-light endoscopy imaging only and is not intended to replace clinical decision making.
Technology
GI Genius is an AI software device trained to process colonoscopy images to detect colorectal lesions including flat polyps. It is connected inline between endoscopic video processors and display monitors and overlays green square markers on detected lesions in real time. The device processes live video streams via advanced algorithms and neural networks, with an inference engine optimized for speed and energy efficiency. It supports various video processors (Fujifilm VP-7000, Olympus CV-180/190, Pentax EPK-i7000).
Performance
Non-clinical verification and validation included system and user-level software testing against requirements, risk management verifications, electrical safety and EMC testing, standalone performance testing comparing to predicate device, and non-inferiority testing of performance with new video processors. Performance improvements were demonstrated with increased lesion detection sensitivity and reduced false positives. The device was found substantially equivalent to the predicate cleared device.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
6/23/2021
1 month - 2
FDA Approval
7/23/2021
Other devices from Cosmo Artificial Intelligence - AI Ltd
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