This completed retrospective study evaluated the clinical performance of ENAD-CADx-01, an artificial intelligence-based medical device software intended to assist healthcare professionals in characterizing colorectal lesions in colonoscopy images. Previously collected colonoscopy images and corresponding histopathological results from Asan Medical Center were analyzed. The performance of ENAD-CADx-01 was evaluated based on its sensitivity, specificity, and overall accuracy in classifying colorectal lesions as neoplasm, hyperplastic polyp, or sessile serrated lesion. No participants were prospectively enrolled, and no study-related intervention was performed.
Study Type
OBSERVATIONAL
Enrollment
1,114
Asan Medical Center
Seoul, Seoul, South Korea
Clinical Sensitivity for Neoplasm
Time frame: Up to 4 weeks
Clinical Specificity for Neoplasm
Time frame: Up to 4 weeks
Clinical Sensitivity for Hyperplastic Polyps
Time frame: Up to 4 weeks
Clinical Specificity for Hyperplastic Polyps
Time frame: Up to 4 weeks
Clinical Sensitivity for Sessile Serrated Lesions
Time frame: Up to 4 weeks
Clinical Specificity for Sessile Serrated Lesions
Time frame: Up to 4 weeks
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