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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.

Sorry, but this document does not contain the information required to answer your question. The document is a 510(k) summary for a medical device (Fox SV PTA Catheter) and focuses on regulatory approval and substantial equivalence to a predicate device. It does not include details about acceptance criteria, study methodologies, or performance data in the way you've outlined.

The provided document describes:

• The device trade name, classification, and regulation number.
• The intended use and device description.
• A statement of substantial equivalence based on non-clinical testing.
• FDA communication regarding the 510(k) premarket notification.

It lacks any mention of:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets or data provenance.
• Number of experts or their qualifications for ground truth establishment.
• Adjudication methods.
• MRMC comparative effectiveness studies or effect sizes.
• Standalone algorithm performance studies.
• Types of ground truth used (e.g., pathology, outcomes data).
• Training set sample sizes or how training set ground truth was established.

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