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FOCUS™-PV Balloon Dilatation Catheters are recommended for percutaneous transluminal angioplasty of the large vessels of the renal, femoral, popliteal, tibial, peroneal, iliac and profunda arteries and for treatment of obstructive lesions of native or synthetic arterovenous dialysis fistulae.

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The provided text describes a 510(k) premarket notification for a medical device, the FOCUS™-PV Balloon Dilatation Catheter. A 510(k) submission is primarily for demonstrating substantial equivalence to a legally marketed predicate device, not for proving the device meets specific acceptance criteria through a formal study with detailed performance metrics as one might find in a de novo application or a clinical trial for a novel device.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study that proves the device meets them in the way clinical trials or performance studies for novel devices typically would.

Here's a breakdown of why the requested information cannot be extracted from the provided text:

1. A table of acceptance criteria and the reported device performance: This document focuses on comparing the new device's specifications and intended use to predicate devices, not on setting and meeting specific performance acceptance criteria from a study.
2. Sample size used for the test set and the data provenance: No test set is described. The 510(k) primarily relies on substantial equivalence to existing devices rather than new performance data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no such test set or ground truth establishment is mentioned.
4. Adjudication method for the test set: Not applicable.
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: Not applicable. This is a medical device (balloon catheter), not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

Explanation based on the provided text:

The document is a 510(k) summary for the FOCUS™-PV Balloon Dilatation Catheter. The core of a 510(k) submission is to demonstrate that a new device is "substantially equivalent" to a predicate device already legally marketed. This means the device has:

• The same intended use as a predicate device.
• The same technological characteristics as a predicate device; OR
• Different technological characteristics from a predicate device but does not raise different questions of safety and effectiveness, and the new device is as safe and effective as the predicate device.

The provided text details:

• Intended Use: The FOCUS™-PV Balloon Dilatation Catheter is intended for percutaneous transluminal angioplasty of large vessels in various arteries and for treatment of obstructive lesions in arteriovenous dialysis fistulae. This is compared to the intended uses of several predicate devices, demonstrating similarity.
• Comparison of Characteristics: A detailed table (TABLE 1) compares the physical and material characteristics of the FOCUS™-PV catheter with several predicate PTA catheters (Schneider Match 35™, Schneider Total Cross™, Medi-tech MS Classique™, Medi-tech Ultra-Thin™, and previous versions of CardioVascular Dynamics' FOCUS™). This comparison highlights similarities in balloon size ranges, lengths, shaft sizes, materials, and guidewire compatibility.

The FDA's letter states that they "determined the device is substantially equivalent... to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified..." This "substantial equivalence" determination is the "acceptance criteria" met in the context of a 510(k) process, rather than specific performance metrics from a dedicated clinical study.

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The FOCUS™-PV Balloon Dilatation Catheter is a balloon dilatation catheter intended for use in percutaneous transluminal balloon dilatation (PTA) of large vessels of the peripheral vasculature.

The FOCUSTM PV Balloon Dilatation Catheter, styled after the Grüntzig technique, is a double lumen catheter with a balloon mounted at the distal tip. Dilatation Balloon catheters are used to exert radial force to dilate narrow vessel segments, based on the principle of hydraulic pressurization applied through an inflatable balloon attached to the distal end of a catheter.

The provided text describes a 510(k) premarket notification for the FOCUS™-PV Balloon Dilatation Catheter. This document is a submission to the FDA demonstrating that a new device is substantially equivalent to a legally marketed predicate device. It is not a clinical study report proving device performance against acceptance criteria in the traditional sense of a clinical trial. Instead, it relies on demonstrating equivalence through comparison to existing devices and engineering testing.

Therefore, many of the requested sections (e.g., sample size for test set, number of experts for ground truth, MRMC study, ground truth for training set) are not applicable to this type of regulatory submission and device.

Here's an analysis based on the information provided:

Acceptance Criteria and Reported Device Performance

The document describes the device, its intended use, and compares it to predicate devices. The "acceptance criteria" for a 510(k) submission primarily revolve around demonstrating substantial equivalence to existing, legally marketed devices and successful completion of engineering (bench) testing to ensure safety and effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not applicable to this 510(k) submission, as it primarily relies on bench testing and comparison to predicate devices, not clinical data from a "test set" as would be used in a diagnostic algorithm study. The "test set" for the engineering tests would be the manufactured devices themselves, but specific numbers are not provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable. Ground truth, in the context of expert consensus, is typically used for diagnostic or screening devices. For a catheter, performance is evaluated through engineering specifications and comparison to existing devices.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable. Adjudication is relevant for interpreting clinical data, not for engineering bench tests or demonstrating substantial equivalence.

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

This is not applicable. The FOCUS™-PV Balloon Dilatation Catheter is a medical device for intervention (angioplasty), not an AI-powered diagnostic tool, and therefore MRMC studies are not relevant.

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

This is not applicable, as it is not an algorithm-based device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For engineering tests, the "ground truth" is typically the established engineering specifications and accepted industry standards for medical device safety and performance. For substantial equivalence, the "ground truth" is the established safety and effectiveness of the predicate devices.

8. The sample size for the training set

This is not applicable, as this is not an AI/machine learning device requiring a training set.

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

This is not applicable, as this is not an AI/machine learning device.

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