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The Cordis AVIATOR PLUS PTA Balloon Dilatation catheter is indicated for Percutaneous Transluminal Angioplasty in the peripheral vasculature, including iliac. femoral, ilio-femoral, popliteal, infra popliteal, renal, and carotid arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for post-dilatation of balloon-expandable and self-expanding stents in the peripheral vasculature.

The Cordis AVIATOR PLUS PTA Balloon Dilatation Catheter is a catheter with a distal balloon and utilizes a rapid exchange design and accepts a 0.014" guide wire. The catheter tip is tapered to facilitate crossing of tight lesions. The proximal hub is used as a balloon inflation port. Two radiopaque marker bands within the balloon indicate the dilating section of the balloon and aid in balloon placement.

The provided text describes a Special 510(k) submission for a device modification, the Cordis AVIATOR PLUS PTA Balloon Dilatation Catheter. This type of submission relies on the concept of "substantial equivalence" to a predicate device, rather than explicit acceptance criteria with numerical performance targets from a clinical study.

Therefore, many of the requested data points (like sample size for test sets, number of experts, MRMC studies, standalone performance, training set details) are not applicable to this type of regulatory submission because clinical performance studies with specific acceptance criteria are generally not required for device modifications that can demonstrate substantial equivalence through non-clinical design verification and validation testing.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable in the traditional sense. The 510(k) summary states: "The safety and effectiveness of the subject Cordis AVIATOR PLUS PTA Balloon Catheter has been demonstrated via data collected from non-clinical design verification and design validation tests and analyses."

This indicates that the device met internal design specifications and engineering performance criteria (e.g., burst pressure, durability, trackability, crossing profile, guidewire compatibility) through bench testing and potentially animal studies, which are not detailed in this public summary. These non-clinical tests would have their own acceptance criteria, but they are not the type of clinical performance criteria usually associated with AI/diagnostic devices.

The "reported device performance" is essentially that it passed these non-clinical tests and is "substantially equivalent" to its predicate device.

2. Sample Size Used for the Test Set and Data Provenance

Not applicable. No clinical "test set" in the context of human data or diagnostic imaging was used for this 510(k) submission. The evaluation was based on non-clinical design verification and validation tests.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not applicable. Ground truth in the context of clinical endpoints or diagnostic accuracy is not relevant for this non-clinical submission. Engineering and quality control experts would have assessed the device against its specifications.

4. Adjudication Method for the Test Set

Not applicable. No clinical test set requiring adjudication was used.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC study is not relevant for a balloon dilatation catheter's 510(k) submission, especially one based on device modification and non-clinical data. This type of study would be for AI-powered diagnostic devices comparing human performance with and without AI assistance.

6. If a Standalone Performance Study Was Done

Not applicable. Standalone (algorithm-only) performance is relevant for AI algorithms. This is a physical medical device (balloon catheter), and its performance is evaluated through non-clinical engineering tests.

7. The Type of Ground Truth Used

For the purpose of this 510(k) submission, the "ground truth" was established by engineering design specifications and performance standards. The device performs as intended according to its design and manufacturing criteria, which are sufficient to demonstrate substantial equivalence to the predicate device.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" in the context of machine learning or AI for this physical device submission.

9. How the Ground Truth for the Training Set Was Established

Not applicable. No training set was used.

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