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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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The Ultra-soft SV Balloon Dilatation Catheters are recommended for percutaneous transluminal angioplasty of the iliac, femoral, ilio-femoral, popliteal, renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

The Ultra-soft SV Percutaneous Transluminal Angioplasty (PTA) 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.

The provided text describes a medical device submission (510(k)) for the Boston Scientific Ultra-soft™ SV Balloon Dilatation Catheter. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and detailed performance metrics as one might find for a novel AI device or a clinical trial with primary endpoints.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts, MRMC study, training set details) are not applicable or not provided in this type of regulatory document.

However, I can extract information related to the safety and performance aspects as described:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance:

• Sample size for test set: Not specifically stated. The document mentions "bench testing" and "biocompatibility testing," which are laboratory tests, not human subject studies with a "test set" in the context of AI or clinical trials.
• Data provenance: Not applicable in the context of clinical data provenance. The data comes from internal laboratory testing (bench and biocompatibility).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Number of experts: Not applicable. This document does not describe a study involving expert consensus for establishing ground truth.
• Qualifications of experts: Not applicable.

4. Adjudication method for the test set:

• Adjudication method: Not applicable. This document describes laboratory testing against design specifications and predicate device equivalence, not clinical test set adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• MRMC study: No. This is a medical device (PTA catheter) submission, not an AI diagnostic/imaging device.
• Effect size: Not applicable.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Standalone performance: Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used:

• Ground truth: For this type of device, "ground truth" would be established by engineering specifications, material standards, and performance characteristics of the predicate device. For example, balloon diameter, inflation pressure, burst pressure, and biocompatibility standards. The document states that the device was designed and tested "to assure conformance to the requirements for its intended use."

8. The sample size for the training set:

• Sample size for training set: Not applicable. This submission concerns a physical medical device, not a machine learning model.

9. How the ground truth for the training set was established:

• Ground truth establishment for training set: Not applicable.

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