EndoScreener
Chengdu Wision Medical Device Co., LTD.EndoScreener is a computer-assisted detection software that automatically identifies and highlights potential polyps during colonoscopy procedures. It processes the live video feed from the colonoscope and overlays blue boxes on suspected polyps, alerting the physician in real-time to improve polyp detection and assist clinical decision-making during colonoscopy in adults.
Intended Use
EndoScreener is intended as a stand-alone software for real-time automatic detection of polyps in colonoscopy video streams during the procedure, to be used by licensed endoscopists in adults with white light colonoscopy.
Technology
The device processes colonoscopy video streams in real-time using a customized deep learning AI model to detect colorectal polyps, outputting bounding boxes highlighting suspected polyps on the video image and optionally alerting physicians. It is similar in function to the predicate device GI Genius but uses distinct AI model customization.
Performance
The device's deep learning algorithm was validated on multiple datasets including 1,138 polyp patients with histological confirmation, showing expected sensitivity and specificity. Clinical performance was assessed in a multi-center randomized controlled trial with 223 patients, demonstrating significantly lower adenoma miss rates and higher adenomas per colonoscopy when using EndoScreener. The device caused no imaging degradation and minimal latency.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
4/30/2021
6 months - 2
FDA Approval
11/19/2021
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