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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. It is limited for use with standard white-light endoscopy imaging only and not intended to replace clinical decision making.

Technology

The device utilizes AI-based software trained to process colonoscopy images, detecting colorectal lesions including flat polyps. It connects between the video processor and endoscopic display monitor, overlaying green square markers on detected lesions in real time, accompanied by a sound alert. The System 200 supports 4K UHD video processing by converting UHD input to HD for AI processing and then back to UHD output, while System 100 uses standard HD input. Optional footswitch and USB K-switch accessories allow the user to toggle detection overlays.

Performance

Performance testing included software verification and validation at system and user levels, risk mitigation verification, electrical safety and electromagnetic compatibility testing for hardware variants including the 4K video board, and non-inferiority testing of AI detection performance using UHD video against predicate device data. Usability studies validated new user interface components like the footswitch.

View FDA documentation

Predicate Devices

No predicate devices specified

Device Timeline

  • 1

    Submission

    4/21/2023

    28 days
  • 2

    FDA Approval

    5/19/2023

Other devices from Cosmo Artificial Intelligence - AI Ltd

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