GI Genius� Module 100 (GGM100.US); GI Genius� Module 200 (GGM200.US); ColonPRO� 4.0 (CPRO40.US)
Cosmo Artificial Intelligence - AI LtdThe GI Genius system by Cosmo Artificial Intelligence is an AI-powered tool that helps doctors detect colonic mucosal lesions, such as polyps and adenomas, in real time during routine white-light endoscopy exams. It enhances lesion detection by analyzing live endoscopy video and highlighting areas of interest on the gastrointestinal tract on the display, supporting clinicians in making accurate diagnoses during colonoscopy procedures.
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
The device includes AI-based software (ColonPRO™ 4.0) and hardware modules (GI Genius™ Module 100 and 200) that connect between the video processor and endoscopic display monitor. It uses advanced algorithms trained on colonoscopy images to detect polyps and lesions in real time, superimposing visual markers on the live video output to highlight detected lesions, accompanied by audio alerts. The new software version has improved detection performance due to retraining of the neural network and includes a new non-clinical Procedure Highlights function to support healthcare organizations' internal programs.
Performance
Performance testing included verification and validation of revised software meeting specified requirements, repetition of previous standalone performance tests from predicate device submission, and risk mitigation measures verification. The updated AI model demonstrated improved lesion detection sensitivity, true positive rate, and lower false positive rate compared to the predicate device. The subject device is substantially equivalent and performs better than the predicate device.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
12/15/2023
28 days - 2
FDA Approval
1/12/2024
Other devices from Cosmo Artificial Intelligence - AI Ltd
- GI Genius System 100 and GI Genius System 2002023 • 510K
- GI Genius2021 • 510K
- GI Genius2021 • DE NOVO
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