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The Wilson-Cook USW Cap and Wire Lock Device is an accessory to be used The Wilson Occh Cook Copy on one guide(s) in place during ERCP procedures.
This device is an accessory to be used with endoscopic biliary devices to lock the wire guide(s) in place during ERCP procedures. The device is supplied sterile and is intended for single use only.

The proposed USW Cap and Wire Guide Locking Device is and one-piece integrated system that secures onto the accessory channel of an endoscope. The access port in the center of the cap allows access of wire quides and other biliary accessories. The wire quide lock allows the practitioner to lock the wire guide in place for continued ductal access while proceeding with other ERCP therapies.

The provided text is a 510(k) summary for the Wilson-Cook USW Cap and Wire Lock, which is a medical device accessory used during ERCP procedures. The document focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study proving performance against specific acceptance criteria for a new AI/medical software device.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth, and expert involvement is not available in this document.

This type of submission (a 510(k)) typically relies on comparisons to legally marketed predicate devices to establish safety and effectiveness, rather than extensive new clinical performance studies with defined acceptance criteria in the way a novel AI/software device would. The "Performance Data" section explicitly states: "We believe the proposed device to be substantially equivalent to the named predicates in terms of Intended Use and performance characteristics tested." This implies that the performance evaluation was a comparison to existing devices, not a standalone study with defined acceptance criteria and detailed quantitative results presented here.

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