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This device is intended to assist in cannulation of the biliary and pancreatic ducts and to aid in bridging difficult strictures during ERCP

The proposed Endoscopic Wire Guide is a modification to existing wire guides currently marketed by Wilson-Cook Medical, Inc. The Endoscopic Wire Guide is .025" in diameter and is compatible with a full range of Wilson-Cook accessories.

The provided 510(k) summary (K122816) does not contain information about the acceptance criteria and the study that proves the device meets those criteria in the context of an AI/ML powered medical device.

This document describes an "Endoscopic Wire Guide," which is a physical medical device (a wire guide for ERCP procedures). The performance data section states: "We believe risks associated with the modifications to the subject device to be adequately addressed through our Design Control Processes. We believe the proposed device to be substantially equivalent to the named predicate in terms of its intended use, performance characteristics tested and biocompatibility."

This suggests that the performance evaluation was likely based on traditional engineering tests, biocompatibility assessments, and comparison to a predicate device's established performance, rather than a clinical study with acceptance criteria related to diagnostic accuracy, sensitivity, specificity, or human reader improvement, which would be typical for an AI/ML-powered device.

Therefore, I cannot provide the requested information for acceptance criteria and related study details for an AI/ML device from this submission.

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