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The Wingman 14C Crossing Catheter is intended to be used in conjunction with steerable guidewires to access discreet regions of the peripheral and/or coronary 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 agents.

The Wingman 14C Crossing Catheter is a device intended to provide additional support to a steerable guidewire when accessing discrete regions of the peripheral and/or coronary 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.

The provided text is a 510(k) summary for the ReFlow Medical, Inc. Wingman 14C Crossing Catheter. It describes the device, its intended use, and comparison to a predicate device, as well as a list of performance tests conducted.

However, the document does not contain the kind of information requested in the prompt regarding acceptance criteria, device performance, sample sizes for test/training sets, expert qualifications, or details about a multi-reader multi-case (MRMC) study for an AI/device. The device described here is a physical medical catheter, not an AI-powered diagnostic device.

Therefore, I cannot fulfill the request using only the provided text. The questions posed are specifically for a study that proves an AI medical device meets acceptance criteria, which this document does not describe.

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