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The Medtronic 5F Sherpa Active NX Guide Catheter is designed to provide a pathway through which therapeutic devices are introduced. The 5F Sherpa Active NX Guiding Catheter is intended for use in the coronary or peripheral vascular system.

The 5F Sherpa Active NX Guiding Catheter consists of a luer hub, strain relief, a shaft (outer jacket, braid wire, an intermediate layer, and inner liner), a secondary segment, a primary segment, tungsten marker band, a segment sleeve and a soft tip.

The 5F Sherpa Active NX Guide Catheter design is based on a four layer design with an inner liner of polyethylene.

The provided text is related to a 510(k) submission for the Medtronic 5F Sherpa Active NX Guide Catheter, a medical device. This document describes the device, its intended use, and its substantial equivalence to predicate devices based on technological characteristics and performance testing.

However, the provided text does not contain any information about acceptance criteria, detailed study designs, sample sizes for test or training sets, expert qualifications, ground truth establishment methods, or the results of comparative effectiveness studies (MRMC) or standalone algorithm performance.

The document is a regulatory submission for a physical medical device (a catheter), not a software or AI-based device that would typically have the kind of performance metrics you are asking about (e.g., accuracy, sensitivity, specificity, expert adjudication).

Therefore, I cannot fulfill your request with the input provided. The requested information pertains to studies typically conducted for AI/machine learning medical devices, which this document is not about.

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