CapsoView (CVV); CapsoCloud (CLD)
CapsoVision, Inc.CapsoView and CapsoCloud are software applications that use artificial intelligence to help doctors review video images from capsule endoscopes. The AI features help highlight potential abnormalities, identify digestive tract locations, and hide frames that cannot be interpreted, all with the goal of making the review process faster and easier for clinicians.
Intended Use
CapsoView is a software application for the download, transcode, and review of videos from CapsoCam Plus Capsule Endoscopes, and the generation of capsule endoscopy reports. CapsoCloud is a cloud-based software application for the review of videos from CapsoCam Plus Capsule Endoscopes, and the generation of capsule endoscopy reports. The software includes artificial intelligence (AI) tools for video analysis designed to aid clinicians in the review of small bowel capsule endoscopy images collected from adult and pediatric patients over two years of age, in whom the capsule endoscopy images were obtained for suspected small bowel bleeding.
Technology
The system integrates several AI algorithms within proprietary desktop (CapsoView) and cloud-based (CapsoCloud) software platforms, processing images from the CapsoCam Plus capsule. Features include 'AI Highlights'—which detects and marks images with suspected lesions, 'Suggested Landmarks'—segmenting the video by GI tract region, and 'Green Detection'—which detects obscured or uninterpretable images, all powered by machine learning algorithms trained on real-world clinical data.
Performance
Performance was demonstrated via standalone and clinical (reader) studies. Standalone assessment of the detection algorithms showed high sensitivity and specificity for lesion, debris, and landmark detection using independent, real-world datasets. A clinical reader study showed that use of the AI-assisted software significantly reduced reading time (by about 11 minutes on average) and improved or maintained detection sensitivity and diagnostic yield compared to conventional review without AI assistance.
Predicate Devices
No predicate devices specified
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