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This device is labeled for Percutaneous Transluminal Angioplasty (PTA) if the femoral, iliac and renal arteries. These catheters are not designed to be used in the coronary arteries.

The BIB PTA Catheter has a tri-axial shaft design which allows for inflation of two balloons, one contained inside the other, and a guidewire lumen for placement inside the vasculature. Both balloons are identical to those currently marketed by NuMed on the Tyshak PTA and Z-Med PTA catheters. The balloons are non-compliant and include radiopaque platinum marker bands on the catheter shaft to facilitate placement of the device under fluoroscopy. The BIB catheter will be available in standard diameters from 8 mm to 24 mm for the outer balloon and 4 mm to 12 mm for the inner balloon. Balloon lengths of 1.5 cm to 5.5 cm will available. The device has an overall shaft length of 110 cm.

The provided text describes a 510(k) summary for the BIB PTA Balloon Catheter. This document is a regulatory submission for a medical device and, as such, focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and results as typically found in clinical trials for novel devices or AI algorithms.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment, as they relate to proving a device meets specific acceptance criteria through a study, is not present in the provided text.

The document states: "The BIB PTA Balloon Catheter have been tested and compared to the Summary of predicate devices listed herein. All data gathered demonstrate the BIB PTA Safety and Effectiveness Catheter is substantially equivalent. No new issues of safety or efficacy have been raised." This indicates that verification and validation activities were performed to support substantial equivalence, but the specifics of those tests and their acceptance criteria are not detailed.

Here's an assessment based on the provided text, indicating where information is not available:

1. Table of Acceptance Criteria and Reported Device Performance

Not available. The document does not provide a table of acceptance criteria or specific performance metrics. It generally states that the device has been "tested and compared" to predicate devices and deemed "substantially equivalent" with "no new issues of safety or efficacy."

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

Not available. The document does not specify a test set sample size or data provenance (e.g., country of origin, retrospective/prospective). It refers to "all data gathered" for demonstrating substantial equivalence.

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

Not applicable/Not available. This device is a PTA Balloon Catheter, not an AI diagnostic device. The concept of "ground truth" and "experts to establish ground truth" as typically applied to image analysis or diagnostic AI algorithms does not directly apply here. For a physical medical device, "ground truth" would be related to its physical properties, biocompatibility, and functional performance, which are evaluated through engineering tests, material analysis, and potentially animal or human clinical data (though no specific clinical study details are provided here beyond reference to predicate devices).

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

Not applicable/Not available. As explained above, an adjudication method for a test set, pertaining to expert consensus on diagnostic outcomes, is not relevant to this type of device and its regulatory submission.

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 specific type of study (MRMC for AI assistance) is not relevant for a physical medical device like a balloon catheter.

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

Not applicable. This concept pertains to AI algorithms, not a physical medical device.

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

Not available. While the document states "biocompatibility tests" were passed and the device was "tested and compared" to predicate devices, it does not specify the type of ground truth used for these tests. For a physical device, ground truth would typically refer to validated measurement techniques for physical properties (e.g., burst pressure, inflation/deflation times), material science standards, and potentially in vivo or in vitro models for biocompatibility and performance.

8. The sample size for the training set

Not applicable/Not available. The concept of a "training set" applies to machine learning algorithms, which is not the subject of this 510(k) submission.

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

Not applicable/Not available. As above, this concept pertains to machine learning algorithms.

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