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The Ultra-soft™ SV Balloon Dilatation Catheters are indicated for percutaneous transluminal angioplasty (PTA) of the carotid, iliac, femoral, illio-femoral, popliteal, and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

The Ultra-soft™ SV Balloon Dilatation Catheter is a Monorail™ catheter with a balloon near the distal tip. The balloon is designed to provide an inflatable segment of known diameter and length at recommended pressures. The distal segment of the balloon catheter is dual lumen and coaxial. The outer lumen is used for inflation of the balloon. The wire lumen permits the use of guidewires (≤0.018 in / 0,46 mm) to facilitate advancement of the catheter to and through the stenosis to be dilated.

This is a 510(k) premarket notification for a medical device, not an AI/ML device. Therefore, the requested information regarding acceptance criteria, study details, and AI/ML-specific metrics is not applicable.

The document describes a conventional medical device, the Boston Scientific Ultra-soft™ SV Balloon Dilatation Catheter, which is used for percutaneous transluminal angioplasty (PTA). The submission aims to demonstrate substantial equivalence to a previously cleared predicate device (K021735) rather than providing performance data against specific acceptance criteria in the way an AI/ML model would.

Here's why the requested information cannot be extracted from this document:

• No AI/ML Component: The device is a physical balloon catheter, not a software algorithm or an AI/ML system.
• Substantial Equivalence: The approval process for such devices typically relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device. This involves comparing technological characteristics, intended use, materials, manufacturing processes, and sometimes rudimentary performance testing (e.g., burst pressure, fatigue for the physical balloon). It does not involve clinical studies with ground truth established by experts or statistical metrics like sensitivity, specificity, or AUC as one would expect for an AI/ML diagnostic tool.
• "Acceptance Criteria" for a Physical Device: For a physical device like a catheter, "acceptance criteria" would refer to engineering specifications and performance standards (e.g., specific burst pressures, flexibility limits, biocompatibility). These are typically found in the full submission, not in the summary provided. The summary focuses on equivalence to a predicate.
• Absence of Clinical Study for Performance: There is no mention of a clinical study or a comparative study involving human readers with or without AI assistance, as the device itself is a tool used by clinicians, not an diagnostic interpretation system.
• No Training/Test Sets or Ground Truth: These concepts are entirely irrelevant to a physical medical device.

In summary, the provided text does not contain any of the information requested because the device is a conventional medical device, not an AI/ML product.

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