Accurate in-vivo optical characterization of colorectal polyps is key to select the optimal treatment regimen during colonoscopy. However, reported accuracies vary widely among endoscopists. We developed a novel intelligent medical device able to seamlessly operate in real-time using conventional white light (WL) endoscopy video stream without virtual chromoendoscopy (blue light, BL). In this work, we evaluated the standalone performance of this computer-aided diagnosis device (CADx) on a prospectively acquired dataset of unaltered colonoscopy videos. An international group of endoscopists performed optical characterization of each polyp acquired in a prospective study, blinded to both histology and CADx result, by means of an online platform enabling careful video assessment. Colorectal polyps were categorized by reviewers, subdivided into 10 experts and 11 non-experts endoscopists, and by the CADx as either “adenoma” or “non-adenoma”. A total of 513 polyps from 165 patients were assessed. CADx accuracy in WL was found comparable to the accuracy of expert endoscopists (CADxWL/Exp; OR 1.211 [0.766–1.915]) using histopathology as the reference standard. Moreover, CADx accuracy in WL was found superior to the accuracy of non-expert endoscopists (CADxWL/NonExp; OR 1.875 [1.191–2.953]), and CADx accuracy in BL was found comparable to it (CADxBL/CADxWL; OR 0.886 [0.612–1.282]). The proposed intelligent device shows the potential to support non-expert endoscopists in systematically reaching the performances of expert endoscopists in optical characterization.

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Artificial intelligence (AI) has the potential to assist in endoscopy and improve decision making, particularly in situations where humans may make inconsistent judgments. The performance assessment of the medical devices operating in this context is a complex combination of bench tests, randomized controlled trials, and studies on the interaction between physicians and AI. We review the scientific evidence published about GI Genius, the first AI-powered medical device for colonoscopy to enter the market, and the device that is most widely tested by the scientific community. We provide an overview of its technical architecture, AI training and testing strategies, and regulatory path. In addition, we discuss the strengths and limitations of the current platform and its potential impact on clinical practice. The details of the algorithm architecture and the data that were used to train the AI device have been disclosed to the scientific community in the pursuit of a transparent AI. Overall, the first AI-enabled medical device for real-time video analysis represents a significant advancement in the use of AI for endoscopies and has the potential to improve the accuracy and efficiency of colonoscopy procedures.

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