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A presentation by Prof. James East, Translational Gastroenterology Unit, Oxford, United Kingdom.
A presentation by Dr. Giulio Antonelli, Castelli Hospital, Rome, Italy.
By harnessing deep learning algorithms and real-time data, GI Genius™ supports physicians to detect and estimate possible histology of colorectal polyps through enhanced visualization in white light colonoscopy.9,10
RCT studies have demonstrated that GI Genius™ intelligent endoscopy module may contribute to a two-fold reduction in miss rate of colorectal neoplasia6 and potentially enhance Adenoma Detection Rate.
Efficacy of Real-Time Computer-Aided Detection of Colorectal Neoplasia in a Randomized Trial
Repici, A., Badalamenti, M., Maselli, R., et al.
Impact of Artificial Intelligence on Miss Rate of Colorectal Neoplasia
Wallace M. B., Sharma P., Bhandari P., et al.
The GI Genius™ intelligent endoscopy module offers a transformative solution — powered by artificial intelligence — to address the challenges of detecting colorectal cancer, early.
GI Genius™ is an artificial intelligence based medical device that has been trained to process colonoscopy images containing regions consistent with colorectal lesions like polyps, including those with flat (non-polypoid) morphology.
GI Genius™ is intended to be used by trained clinicians as an adjunct to white light colonoscopy for the purposes of highlighting regions suspected to have visual characteristics consistent with different types of mucosal abnormalities (e.g. colorectal polyps).
If characterization support is enabled, a polyp detected and highlighted by GI Genius™ is consistently framed in white light video colonoscopy, based on the visual characteristics of the detected polyp, GI Genius™ provides an estimate of the possible polyp histology.
GI Genius™ is intended to be used as an adjunct to colonoscopy procedures and is not intended to replace endoscopist assessment or histopathological sampling.
The whole colonoscopy video and the regions highlighted by GI Genius™ system must be independently assessed by the endoscopist, with all the available and obtainable information, without primarily relying on GI Genius™ system output.
GI Genius™ system does not prescribe any clinical management action regarding the detected and highlighted polyps. The endoscopist must take appropriate actions according to the standard clinical practice.
GI Genius™ system does not make any elaboration or alteration of the colonoscopy video streaming, it only overlays graphical markers.
If the device is used outside of Instructions For Use it could potentially lead to inappropriate diagnostic information being displayed to the user (e.g. to analyze images from an unintended patient population, on images acquired with incompatible imaging hardware or incompatible image acquisition parameters).
Incorrect detection or characterization of lesion(s) may lead to false positive or false negative which may result in incorrect patients management with possible adverse effects: Unnecessary treatment, unnecessary additional medical imaging and/ or unnecessary additional diagnostic workup such as biopsy, complications, including incorrect diagnosis and delay in disease management.
Device failure could lead to the absence of results, delay of results or incorrect results, which could likewise lead to inaccurate patient assessment.
In the event of unrecoverable failure please switch off and revert to Non AI enhanced colonoscopy.
* Information is from a Clinical Evaluation Report. CB-17-08 System. LQ20052607.