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The Fox SV PTA Catheter is intended for dilatation of lesions in the femoral, renal, iliac, popliteal, peroneal, and profunda arteries and native or synthetic arteriovenous dialysis fistulae. This catheter is not intended for the delivery or expansion of stents.

The Fox SV PTA Catheter is a standard over-the-wire PTA catheter. The double lumen catheter has a balloon located near the distal tip. One lumen is used for inflation of the balloon, while the second lumen allows access to the distal tip of the catheter for guidewire insertion (max 0.018"). The balloon material expands to a known diameter at specific pressure.

The provided document, a 510(k) summary for the Fox SV PTA Catheter, does not contain information on acceptance criteria or a study proving the device meets acceptance criteria in the format requested.

The document states: "The Fox SV PTA Catheter is substantially equivalent to the predicate device. Substantial equivalence was confirmed through non-clinical testing."

This indicates that the primary method for demonstrating safety and effectiveness for this 510(k) submission was a comparison to a legally marketed predicate device (Fox Plus PTA Catheter K040954) through non-clinical testing, rather than a clinical study with defined acceptance criteria and performance metrics.

Therefore, I cannot provide the requested information as it is not present in the given text. The document focuses on demonstrating substantial equivalence, device description, and intended use as per 510(k) requirements, not on detailed performance study results against specific acceptance criteria.

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