MAGENTIQ-COLO (ME-APDS)

MAGENTIQ-COLO (ME-APDS) is a computer-aided detection software system that assists endoscopists during colonoscopy procedures by automatically detecting and highlighting regions of the video that may contain polyps or other mucosal abnormalities. The system processes video frames in real-time using deep machine learning algorithms and displays the detected lesions on a separate screen. It is intended as an adjunct tool only and does not replace clinical decision-making or histopathological diagnosis.

The device uses a Computer-Aided Polyp Detection (CADe) engine with deep machine learning and supporting algorithms to process colonoscopy video frames in real-time. The primary modification from the predicate device is a revised AI polyp detection algorithm following neural network retraining, along with minor GUI changes. All other device features remain identical to the predicate device (K252178). The system includes a tool detection feature that removes bounding box presentation when endoscopic instruments enter the field of view.

Not stated in this summary.

The modified ME-APDS is substantially equivalent to its predicate device because it has the same intended uses, indications, and principles of operation; similar technological characteristics with only minor algorithm and GUI refinements; and performance testing demonstrating comparable safety and effectiveness (99.7%-99.2% polyp recall with histology, 96.9%-90.9% overall). The minor differences do not alter intended use or raise new safety/effectiveness issues, and prior clinical validation from K223473 remains applicable.