Abstract
Background and study aims Large adenomas are sometimes misidentified as cancers during colonoscopy and are surgically removed. To address this overtreatment, we developed an artificial intelligence (AI) tool that identified cancerous pathology in vivo with high specificity. We evaluated our AI tool under the supervision of a government agency to obtain regulatory approval. Patients and methods The AI tool outputted three pathological class predictions (cancer, adenoma, or non-neoplastic) for endocytoscopic images obtained at 520-fold magnification and previously trained on 68,082 images from six academic centers. A validation test was developed, employing 500 endocytoscopic images taken from various parts of randomly selected 50 large (≥ 20 mm) colorectal lesions (10 images per lesion). An expert board labelled each of the 500 images with a histopathological diagnosis, which was made using endoscopic and histopathological images. The validation test was performed using the AI tool under a controlled environment. The primary outcome measure was the specificity in identifying cancer. Results The validation test consisted of 30 cancers, 15 adenomas, and five non-neoplastic lesions. The AI tool could analyze 83.6 % of the images (418/500): 231 cancers, 152 adenomas, and 35 non-neoplastic lesions. Among the analyzable images, the AI tool identified the three pathological classes with an overall accuracy of 91.9 % (384/418, 95 % confidence interval [CI]: 88.8 %-94.3 %). Its sensitivity and specificity for differentiating cancer was 91.8 % (212/231, 95 % CI: 87.5 %-95.0 %) and 97.3 % (182/187, 95 % CI: 93.9 %-99.1 %), respectively. Conclusions The newly developed AI system designed for endocytoscopy showed excellent specificity in identifying colorectal cancer.