MAGENTIQ-COLO (ME-APDS)
Magentiq Eye LTDMAGENTIQ-COLO (ME-APDS) is a computer-aided detection system used alongside standard white-light colonoscopy videos to help endoscopists identify suspicious regions indicative of polyps. It processes live video frames using AI to highlight possible lesions during colonoscopy, aiming to improve detection rates and assist clinicians in real-time without replacing clinical judgement or histopathological diagnosis.
Intended Use
ME-APDS (Magentiq Eye’s Automatic Polyp Detection System) is intended to be used by endoscopists as an adjunct to the common video colonoscopy procedure (screening and surveillance), aiming to assist the endoscopist in identifying lesions during colonoscopy procedure by highlighting regions with visual characteristics consistent with different types of mucosal abnormalities that appear in the colonoscopy video during the procedure. Highlighted regions can be independently assessed by the endoscopist and appropriate action taken according to standard clinical practice. ME-APDS is trained to process video images which may contain regions consistent with polyps. ME-APDS is limited for use with standard white-light endoscopy imaging only. ME-APDS is intended to be used as an adjunct to endoscopy procedures and is not intended to replace histopathological sampling as means of diagnosis.
Technology
The device acquires digital video output from local endoscopy cameras and processes the video frames in real-time using deep machine learning and supporting algorithms to detect regions consistent with mucosal abnormalities like polyps. Detection results are presented by highlighting suspicious areas on the video on a separate screen. The technology is based on a Computer-Aided Polyp Detection (CADe) engine identical to the predicate device, with updates to hardware and compatible endoscopy systems but no changes to the AI algorithm.
Performance
The device underwent non-clinical testing including software validation, safety and EMC testing, and latency assessment showing median annotation delay of 133ms for FHD and 157ms for 4K video. Standalone performance testing on 212 unique colonoscopy videos with 702 polyps demonstrated high recall rates up to 99.7% for histology-verified polyps with an acceptable false positive rate. Clinical validation was previously conducted for the predicate device and is considered sufficient for this modified device. Overall, performance supports the device's safety and effectiveness.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
12/27/2024
28 days - 2
FDA Approval
1/24/2025
Other devices from Magentiq Eye LTD
- ME-APDS�; MAGENTIQ-COLO�2023 • 510K
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