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The CenterFlow Molding Balloon Catheter is intended to assist in the dilatation of self-expanding endoprostheses in large diameter vessels.

The CenterFlow Molding Balloon Catheter is intended to assist in the dilatation of self-expanding endoprostheses in large diameter vessels. When used in its indications for use, it is a low-permissive, over-the-wire, single-use device comprised of two elongated non-compliant nylon balloons that are attached to and within a nitinol support frame. The two elongated balloons are constrained in a zigzag arrangement by the nitinol support frame. Upon inflation, this configuration enables expansion of the device head through balloon straightening, to assist the dilatation of self-expanding endoprostheses in large diameter vessels. Expansion of the zig-zag balloon configuration creates a central orifice permitting maintained hemodynamic flow during the molding procedure. The inflation lumen is 9 Fr and is made of PEBAX 72D. A co-axial PEBAX 72D guidewire lumen runs through the inflation lumen and device head and terminates into a distal polycarbonate tip. Two platinum-iridium markers provide angiographic visualization of the distal and proximal balloon edges to facilitate intravascular balloon placement prior to inflation. The catheter has a working length of 110 cm and it connects proximally to a standard Y-connector at the proximal end. The Y-connector allows for separation of two lumens - an angled luer-lock hub to inflate and deflate the balloon and a straight luer-lock hub which accepts a 0.035" guidewire. The device is deflated and inserted over the guidewire through the hemostasis valve of a transfemoral introducer sheath.

The provided text is a 510(k) premarket notification letter and summary for the CenterFlow Molding Balloon Catheter. This document details the device's intended use, design, and comparison to a predicate device. However, it does not contain any information regarding specific acceptance criteria or a study that proves the device meets those criteria in terms of performance metrics like accuracy, sensitivity, or specificity.

The "Non-Clinical Tests Summary & Conclusions" section lists the types of tests performed (Benchtop performance testing, Biological Safety Evaluation, In vivo safety evaluation, Packaging validation, Shelf-life validation, Usability Engineering evaluation), but it does not provide any quantitative results, acceptance criteria, or details of a study with a test set, ground truth, or expert involvement.

Therefore, I cannot provide the requested information for acceptance criteria and the study that proves the device meets them because the provided text does not contain any of that specific data.

Here’s what I can extract based on the information not present in the document:

1. A table of acceptance criteria and the reported device performance:

   • Acceptance Criteria: Not available in the provided text.
   • Reported Device Performance: Not available in the provided text (beyond a general statement that "the subject device is substantially equivalent to the predicate device" based on non-clinical testing).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not available for performance testing. (Note: "In vivo safety evaluation" is mentioned, which implies animal or human subjects, but no details on size or provenance are given for performance evaluation.)

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): Not available.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not available.

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 device is a physical catheter, not an AI or imaging diagnostic tool that would involve "human readers" or "AI assistance."

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable for this type of medical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not available.

8. The sample size for the training set: Not applicable (not an AI/ML device with a training set).

9. How the ground truth for the training set was established: Not applicable.

In summary, the provided FDA 510(k) notification focuses on establishing substantial equivalence based on design features and general non-clinical testing (benchtop, biocompatibility, in vivo safety, etc.) for a physical medical device (balloon catheter), rather than providing detailed performance metrics typically associated with diagnostic or AI-powered devices. The document explicitly states the "Non-Clinical Tests Summary & Conclusions" showed substantial equivalence but does not elaborate on the specific quantifiable results or the methodology behind them.

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