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The Wingman 35 Crossing Catheter is intended to be used in conjunction with steerable guidewires to access discreet regions of the peripheral vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices and provide a conduit for the delivery of saline solutions or diagnostic/therapeutic agents.

The Wingman 35 Crossing Catheter is a device intended to provide additional support to a steerable guidewire when accessing discrete regions of the peripheral vasculature.

The device consists of a support catheter, with a concealed radiopaque beveled guide-tip, and activating handle. The through-lumen of the device can serve as a conduit for the delivery of diagnostic and therapeutic agents.

I am sorry, but based on the provided text, I cannot extract the information required to describe the acceptance criteria and the study that proves the device meets the acceptance criteria in the format you requested.

Here's why:

• This document is an FDA 510(k) clearance letter and its summary. It primarily focuses on demonstrating "substantial equivalence" of a new device (Wingman 35 Crossing Catheter) to a previously cleared predicate device.
• The "Performance Data" section (VII) lists categories of tests but explicitly states: "The Wingman 35 Crossing Catheter met all specified criteria and did not raise new safety or performance questions. Based on the performance testing the Wingman 35 Crossing Catheter was found to be substantially equivalent to the predicate device." It does not provide details about specific acceptance criteria or the numerical results of these tests.
• The document is about a mechanical catheter, not an AI/ML-driven device. Therefore, concepts like "AI assistance," "human readers," "ground truth," "training set," "test set," "number of experts," and "adjudication methods" as they pertain to AI development and validation are irrelevant to this specific device and are not mentioned in the text.

The information you are asking for (acceptance criteria and study details with respect to AI/ML performance) would typically be found in a more detailed clinical study report or a specific section of a regulatory submission for an AI/ML medical device, not a 510(k) summary for a mechanical catheter.

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