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The Cronus HP PTA Balloon Catheter is indicated for Percutaneous Transluminal Angioplasty in the following vessel areas:

• Femoral arteries
• Popliteal arteries
• Iliac arteries
• Renal arteries
• For the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
  These catheters are not intended for use in coronary arteries or the neurovasculature.

The Cronus™ HP PTA Balloon Catheter is intended for PTA (Percutaneous Transluminal Angioplasty) procedures. It is an over the wire (OTW) 0.035" dual lumen catheter with a distally mounted semi- compliant inflatable balloon and a flush cut tip. The catheter manifold includes two lumens. A y-connector adaptation is located at the proximal part of the catheter and provides access to the two different lumens. The lumen marked "GW" is the central lumen of the catheter which terminates at the distal tip. This lumen is used to pass the catheter over a guidewire with a maximum outer diameter of 0.035 inches. The lumen, marked "BALLOON" is used to inflate and deflate the dilatation balloon with a solution of contrast medium and saline. The balloon has two radiopaque markers for positioning the balloon relative to the stenosis. The balloon segment expands to a known diameter at a specific inflation pressure.
The Cronus™ HP PTA Balloon Catheter is sterilized using ethylene oxide gas and satisfies a minimum Sterility Assurance Level (S.A.L.) of 10 °. Shelf-life is determined to be 4 years.
The device is available in multiple configurations ranging in sizes of balloon diameter 4-10mm, balloon lengths 20-80mm, and catheter lengths of 45 and 80cm

This document is a 510(k) Premarket Notification from the FDA regarding the Cronus HP PTA Balloon Catheter. It focuses on demonstrating substantial equivalence to a predicate device, rather than proving a device meets specific acceptance criteria based on performance study results.

Therefore, the requested information regarding acceptance criteria and a study proving the device meets them cannot be extracted from the provided text. The document explicitly states:

• "This submission does not warrant any clinical testing, therefore no clinical testing was performed for or provided in this submission."

This indicates that clinical performance studies to establish specific acceptance criteria and prove the device meets them were not part of this 510(k) submission. The submission relies on non-clinical (bench) testing and comparison of technological characteristics to a legally marketed predicate device to demonstrate substantial equivalence.

Here's what can be inferred from the document regarding the device's evaluation (though it doesn't directly address the acceptance criteria and study proving performance as you've requested):

The 510(k) process for this device, as detailed, focuses on demonstrating substantial equivalence to an existing predicate device (Cronus HP (K151141)). This means the manufacturer is asserting their new device is as safe and effective as the predicate device, not necessarily that it meets a set of isolated performance criteria from a clinical trial.

The "tests" mentioned are primarily bench tests and biocompatibility tests, which establish the basic safety and physical characteristics of the device, and ensure it functions as intended in a laboratory setting. These are not clinical studies designed to show performance against specific clinical acceptance criteria.

To answer your specific questions in the context of this document's limitations:

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

   • Not applicable / Not provided. The document lists various non-clinical tests (e.g., packaging burst, balloon compliance, balloon rated burst pressure) and states they were "conducted successfully." However, it does not provide specific quantitative acceptance criteria or reported performance values for these tests in a table, nor does it present the results of a clinical study proving performance against acceptance criteria.

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

   • Not applicable / Not provided for clinical data. Since no clinical testing was performed, there's no test set for clinical data. For the bench tests, sample sizes are not explicitly stated in this summary. Data provenance would be laboratory testing in an ISO-certified facility likely, but specifics are missing.

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

   • Not applicable. No clinical test set where "ground truth" would be established by experts is mentioned.

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

   • Not applicable. No clinical test set requiring adjudication is mentioned.

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 PTA Balloon Catheter, not an AI-assisted diagnostic tool.

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

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

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

   • Not applicable. For the bench tests, physical measurements and engineering standards serve as the "truth," but this isn't analogous to clinical ground truth.

8. The sample size for the training set:

   • Not applicable. This device does not involve machine learning or a "training set."

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

   • Not applicable.

In summary, this FDA document is a 510(k) summary for a physical medical device that achieved clearance through demonstrating substantial equivalence to a predicate device, primarily via non-clinical testing. It did not involve or report on a clinical study designed to prove the device met specific acceptance criteria.

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