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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 expansion or delivery 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 (maximum 0.018"). The balloon material expands to a known diameter at specific pressures.

The provided text describes a 510(k) summary for the Fox™ sv PTA Catheter, asserting its substantial equivalence to predicate devices. It focuses on in vitro bench tests and biocompatibility testing to demonstrate safety and effectiveness.

However, the document does not contain the specific information requested in the prompt regarding acceptance criteria, reported device performance (beyond general safety and effectiveness), details about a study that proves it meets these criteria, sample sizes for test or training sets, data provenance, number or qualifications of experts, adjudication methods, MRMC studies, standalone algorithm performance, or how ground truth was established.

The 510(k) summary primarily addresses:

• Device Identification: Submitter, trade name, common name, classification details.
• Predicate Devices: Identifies K062843 (Fox sv PTA Catheter) and K942094 (Cordis® SAVVY® PTA Dilatation Catheter).
• Device Description: Standard over-the-wire PTA catheter with a double lumen and balloon.
• Intended Use: Dilatation of lesions in various arteries and arteriovenous dialysis fistulae.
• Technological Characteristics Comparison: Notes that the subject device is identical to the predicate Fox sv PTA Catheter except for an extended catheter length (150cm from 135cm). It also compares favorably to the Cordis® SAVVY® PTA Catheter across multiple characteristics.
• Summary of Substantial Equivalence: States that "The results of the in vitro bench tests and analyses and biocompatibility testing demonstrate the safety and effectiveness of the Fox sv PTA Catheter subject device."

Therefore, based solely on the provided text, the requested details about acceptance criteria and a specific study proving device performance are not available.

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