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The AngioSculpt PTA Scoring Balloon Catheter is intended for dilatation of lesions in the iliac, femoral, ilio-femoral, popliteal, infra popliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. Not for use in the coronary or neuro-vasculature.

The AngioSculpt catheter is a standard two-lumen catheter with a scoring balloon near the distal tip. The distal end of the catheter has a conventional nylon-blend balloon with a nitinol scoring element that wraps around the balloon. The scoring element creates focal concentrations of dilating force which minimizes balloon slippage and assists with luminal expansion of stenotic arteries. The balloon has radiopaque markers to aid in positioning the balloon in the stenosis, and is designed to provide an expandable segment of known diameter and length at a specific pressure.

This document is a 510(k) Premarket Notification for the AngioSculpt® PTA Scoring Balloon Catheter, seeking substantial equivalence to previously cleared devices. It describes the device, its intended use, and compares it to predicate devices. However, the document does not contain specific acceptance criteria, study details, or performance data in the format requested.

Therefore, I cannot provide the requested table and detailed information based on the provided text. The document focuses on demonstrating substantial equivalence rather than presenting a performance study with acceptance criteria.

Information not available in the provided document:

• A table of acceptance criteria and reported device performance.
• Sample sizes used for test sets.
• Data provenance (country of origin, retrospective/prospective).
• Number and qualifications of experts for ground truth.
• Adjudication method for the test set.
• Results of a multi-reader multi-case (MRMC) comparative effectiveness study or any effect size of human reader improvement with AI assistance (as this is a medical device, not an AI product).
• A standalone algorithm performance study (as this is a medical device, not an AI algorithm).
• Type of ground truth used (pathology, outcomes data, etc.).
• Sample size for the training set.
• How the ground truth for the training set was established.

The document states: "Design verification and validation testing demonstrated adequate device performance and confirmed that no new questions of safety or effectiveness for peripheral balloon angioplasty devices were raised." However, it does not provide the specifics of these tests, their acceptance criteria, or the results.

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