GI Genius™ intelligent endoscopy module 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 whitelight endoscopy examinations of patients undergoing screening and surveillance endoscopic mucosal evaluations. The GI Genius™ computer-assisted detection device is limited for use with standard white-light endoscopy imaging only. This device is not intended to replace clinical decision-making.
Contraindications and Warnings
GI Genius™ system is intended to be used as an adjunct to colonoscopy procedures and is not intended to replace endoscopist assessment or histopathological sampling. GI Genius™ system does not make any elaboration or alteration of the colonoscopy video streaming, it only overlays graphical markers.
- Danger: Do not use this system for any purpose other than its intended use.
- Danger: The system does not perform any diagnosis.
- Caution: The sale, distribution, and the use of the GI Genius™ system are restricted to prescription use in accordance with 21 CFR 801.109.
- Caution: The device is not intended to be used as a stand-alone diagnostic device.
- Caution: The device is not intended to characterize lesions in a manner that would potentially replace biopsy sampling.
- Caution: The device is not intended to replace clinical decision-making.
- Caution: The device is not intended to be used with equipment that was not tested against during validation activities.
- Caution: The device has not been studied in patients with Inflammatory Bowel Disease (IBD), history of CRC, or previous colonic resection. The device performance may be negatively impacted by mucosal irregularities such as background inflammation from certain underlying disease.
- Caution: Users should be aware, when using automated systems such as the GI Genius™ that provide assistance in identifying suspicious lesions, that a high level of reliance may be placed on the system output, potentially leading to user complacency and a bias towards accepting the system output results, rather than using the device as intended. The device is intended to provide adjunctive information to the endoscopist who performs endoscopic evaluations with an expected high level of clinical expertise. Placing too much reliance on the system in this way may lead to an unacceptably low level of procedural oversight ('situational awareness'), sub-par evaluation of the patient, and eventual endoscopist skill degradation, following which retraining may be necessary.
- Danger: Using incompatible equipment can result in patient injury or equipment damage and makes it impossible to obtain the expected functionality.