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The SKOUT system is a software device designed to detect potential colorectal polyps in real time during colonoscopy examinations. It is indicated as a computer-aided detection tool providing colorectal polyps location information to assist qualified and trained gastroenterologists in identifying potential colorectal polyps during colonoscopy examinations in adult patients undergoing colorectal cancer screening or surveillance. The SKOUT system is only intended to assist the gastroenterologist in identifying suspected colorectal polyps and the gastroenterologist is responsible for reviewing SKOUT suspected polyp areas and confirming the presence or absence of a polyp based on their own medical judgment. SKOUT is not intended to replace a full patient evaluation, nor is it intended to be relied upon to make a primary interpretation of endoscopic procedures, medical diagnosis, or recommendations of treatment/course of action for patients. SKOUT is indicated for white light colonoscopy only.

The SKOUT® system is a software-based computer aided detection (CADe) system for the analysis of highdefinition endoscopic video during colonoscopy procedures. The SKOUT system is intended to aid gastroenterologists with the detection of potential colorectal polyps during colonoscopy by providing an informational visual aid on the endoscopic monitor using trained software that processes the endoscopic video in real time. Users will primarily interact with the SKOUT system by observing the software display, including the polyp detection box and device status indicator signal. Polyp Detection Notification: The SKOUT system has a main graphical user interface (GUI) feature of the polyp detection notification. The polyp detection notification is a two-dimensional blue rectanqular outline generated around any suspected polyps on the endoscopic video feed. If there is no polyp detected, the bounding box does not appear. SKOUT® system pauses polyp detection when an endoscopic tools are detected in the video feed to ensure that the bounding box does not hinder any surgical procedure, biopsy, or resection or this may also occur when lighting conditions are deemed to be inadequate. Device Status Indicator: The SKOUT system has an additional GUI feature that notifies users of the current device status (active or error): - a two-dimensional green box with letter (S) when the device is powered on and actively processing video. - o a two-dimensional grav box with letter (S) when a surgical tool is present. - a red (X) with an error message: when there is an error with the video processing function of the SKOUT system, the green box will be replaced with a red X and error message to indicate an error has occurred.

The SKOUT system is a software device designed to detect potential colorectal polyps in real time during colonoscopy examinations. It is indicated as a computer-aided detection tool providing colorectal polyps location information to assist qualified and trained gastroenterologists in identifying potential colorectal polyps during colonoscopy examinations in adult patients undergoing colorectal cancer screening or surveillance. The SKOUT system is only intended to assist the gastroenterologist in identifying suspected colorectal polyps and the gastroenterologist is responsible for reviewing SKOUT suspected polyp areas and confirming the presence of a polyp based on their own medical judgment. SKOUT is not intended to replace a full patient evaluation, nor is it intended to be relied upon to make a primary interpretation of endoscopic procedures, medical diagnosis, or recommendations of treatment/course of action for patients. SKOUT is indicated for white light colonoscopy only.

The SKOUT™ system is a software-based computer aided detection (CADe) system for the analysis of high-definition endoscopic video during colonoscopy procedures. The SKOUT™ system is intended to aid gastroenterologists with the detection of potential colorectal polyps during colonoscopy by providing an informational visual aid on the endoscopic monitor using trained software that processes the endoscopic video in real time. Users will primarily interact with the SKOUT™ system by observing the software display, including the polyp detection box and device status indicator signal.