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The 0.035" and 0.025" Guidewire is indicated for use in the peripheral vasculature. The 0.014", 0.016", and 0.018" guidewires are indicated for use in the peripheral and coronary vasculature.

The guidewire is constructed of nitinol (nickel-titanium alloy). The nitinol core extends from the distal tip of the guidewire to the proximal shaft end. The distal tip is a helically coiled coil gold plated tungsten wire. The guidewire is coated with a coating(s)to help facilitate smooth passage.

The provided document is a 510(k) Summary for the Nitrex™ Nitinol Guidewire, which details its substantial equivalence to predicate devices. It does not contain information regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment for a device performance study as typically understood for AI/ML-based medical devices.

Instead, the "Testing" section states: "Verification/validation testing demonstrated that devices utilizing the new coating formulation meet the original verification and validation requirements." This implies that the device (a guidewire) was evaluated against established engineering and performance specifications for medical guidewires, not against a clinical test set to assess AI diagnostic or prognostic accuracy.

Therefore, I cannot provide the requested information in the format of acceptance criteria and study details for an AI/ML device because the document describes a traditional medical device (a guidewire) approval process based on substantial equivalence and engineering verification/validation, not an AI/ML performance study.

If there were a different document related to an AI/ML device, I would be able to extract and present that information.

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