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Cook Urological Wire Guides are used for ureteral access, to establish a tract, and assist in the placement, replacement, and exchange of devices during urological procedures. For the Roadrunner Wire Guides the intended use also includes use in a torturous or kinked ureter, traversing a large stone in route to the kidney, or in cases demanding enhanced control and high radiopacity. These wire guides are not intended for PTCA use.

Cook Wire Guides are designed to be used during Urological procedures where use of a wire quide is warranted. The wire quides consists of a single piece of wire tightly wound into coils from tip to tip. Two additional wires are present inside the coils, one called a flat safety wire and the other a round wire. Some of the wire guides are coated with a polymer sleeve, some with PTFE, some are stainless steel, and some are hydrophilically coated. Several variations of Cook Wire Guides are available. The wire quided sterile in peel-open packages and are intended for onetime use.

The provided text describes Cook Wire Guides and their substantial equivalence to existing devices. However, it does not contain the specific information required to complete a table of acceptance criteria and reported device performance, nor details about a study that would demonstrate meeting such criteria.

Specifically, the text mentions:

• "Biocompatibility, sterility and performance testing were performed in accordance to Food and Drug Administration guidance's and recognized international standards."
• "Testing data and information are included in this submission."

This indicates that such testing was done and submitted, but the actual results, the acceptance criteria used, and the details of how the studies were conducted (like sample size, ground truth establishment, expert qualifications, etc.) are not included in this document.

Therefore, I cannot provide a table of acceptance criteria and reported device performance from the given input, nor can I answer points 2 through 9 regarding study details. The information about the study design and results is simply not present in the provided 510(k) summary and FDA letter.

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