SKOUT Software
Iterative Scopes Inc.The SKOUT Software is an artificial intelligence (AI) based computer-aided detection tool designed to assist gastroenterologists during colonoscopies by identifying potential colorectal polyps in real time. It processes high-definition endoscopic video and highlights suspected polyps with visual markers on the video feed, helping clinicians detect polyps more effectively and support colorectal cancer screening and surveillance.
Intended Use
The SKOUT system is a software device designed to detect potential colorectal polyps in real time during colonoscopy examinations, providing colorectal polyp location information to assist qualified and trained gastroenterologists during colorectal cancer screening or surveillance.
Technology
SKOUT uses AI-based algorithms to analyze high-definition endoscopic video in real time, displaying blue rectangular markers around suspected polyps on the video feed. It includes hardware and software components integrated with endoscopy systems, a user interface showing detection and device status, and safety features such as disabling detection markers when a biopsy tool is in use.
Performance
Performance testing included software verification and validation, electrical safety, electromagnetic compatibility, non-clinical standalone algorithm performance on 79 videos with 94 polyps showing 97.87% true positive rate at object level, clinical testing via a multicenter, randomized controlled trial with 1,359 patients demonstrating a statistically significant increase in adenomas detected per colonoscopy with SKOUT, and human factors validation confirming safe intended use.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
11/22/2021
8 months - 2
FDA Approval
8/12/2022
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