EW10-EC02 Endoscopy Support Program
FUJIFILM CorporationThe EW10-EC02 Endoscopy Support Program is an AI-driven software tool designed to support endoscopists by detecting colon polyps and adenomas in real time during standard colonoscopy exams. It processes real-time endoscopic video images from White Light Imaging and Linked Color Imaging to highlight potential lesions, helping clinicians improve diagnosis and patient outcomes without replacing clinical judgment.
Intended Use
A computer-assisted reading tool designed to aid endoscopists in detecting colonic mucosal lesions (such as polyps and adenomas) in real time during standard endoscopy examinations with WLI and LCI imaging.
Technology
AI-based computer-aided diagnosis software that analyzes real-time colonoscopy video images using deep learning algorithms to detect polyps and adenomas, compatible with WLI and LCI endoscopic imaging.
Performance
The device underwent extensive software verification and validation, non-clinical standalone testing on large datasets of colonoscopy videos showing high sensitivity (>95%) for lesion detection in both WLI and LCI modes, minimal video delay, and a clinical multicenter randomized controlled trial with over 1000 subjects that demonstrated improved adenoma per colonoscopy rates and safety comparable to conventional colonoscopy.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
3/17/2023
9 months - 2
FDA Approval
12/15/2023
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