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The AngioSculpt PTA Scoring Balloon Catheter is intended for dilatation of lesions in the iliac, femoral, ilio-femoral, popliteal, and infra popliteal 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 from AngioScore, Inc. to the FDA for their AngioSculpt PTA Scoring Balloon Catheter. The purpose of this notification is to demonstrate that the device is substantially equivalent to legally marketed predicate devices, not to conduct a study proving acceptance criteria for a new AI/software device.

Therefore, the requested information regarding acceptance criteria and a study proving device meets acceptance criteria, in the context of AI/software performance, cannot be extracted from this document. The document describes a medical device, a physical balloon catheter, and the 510(k) summary focuses on demonstrating substantial equivalence to existing devices through a comparison of design, indications for use, and performance, rather than a clinical trial with acceptance criteria for an AI algorithm.

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