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The XO Constrain Percutaneous Transluminal Angioplasty Constraining Catheter is intended to be used in conjunction with a PTA balloon to facilitate dilation and apposition of the scoring/constraining surface to the stenal in the iliac, femoral, ilio-popliteal, infra-popliteal, and renal arteries, and for treatment of obstructive or synthetic arteriovenous dialysis fistulae. Not for use in the coronary or neuro-vasculature.

The XO Constrain Percutaneous Transluminal Angioplasty Constraining Catheter is a balloon dilation scoring/constraining catheter. It consists of a metal alloy wire shaft connected to the metal alloy expandable constraining structure (CS) at the distal atraumatic tapered tip. It works with offthe-shelf compliant and semi-compliant balloons to expand the constraining structure and is designed to facilitate uniform, atraumatic balloon expansion, vessel scoring, and rewrap within small or distal vessels and arteries. The XO Constrain catheter is designed to be used with balloons between the sizes of 6 - 20mm in length and 1.5 - 4.0mm in diameter and may work with PTA and peripheral use PTCA balloon catheters with a standard over-the-wire (OTW) or rapid exchange (RX) procedural approaches. The expansion of the CS is determined by the balloon inflation diameter. Upon deflation the CS returns to its original shape and is removed from the vessel along with the balloon catheter. The XO Constrain should not be used in the coronary or neuro-vasculature.

The device under consideration is the XO Constrain™ Percutaneous Transluminal Angioplasty Constraining Catheter.

Based on the provided text, the device's acceptance criteria are addressed through a series of Functional/Safety Testing and Animal Testing. The manufacturer, Transit Scientific, LLC, states that "All data met pre-determined acceptance criteria" for these tests and that the device is "substantially equivalent to the cited predicate device."

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document lists various tests performed to ensure the device meets predefined acceptance criteria, but it does not explicitly state specific quantitative acceptance criteria or the numerical performance results for each test. Instead, it broadly states that "All data met pre-determined acceptance criteria."

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

The document does not specify the sample sizes used for any of the tests (biocompatibility, performance bench testing, or animal testing).
The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective or prospective. It implies internal testing by Transit Scientific, LLC.

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

This information is not provided in the document. The document describes engineering and biological testing, not clinical studies involving expert interpretation of data.

4. Adjudication method for the test set

This information is not applicable/provided. The tests described are laboratory and animal studies, not clinical trials requiring adjudication of expert interpretations.

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

There is no mention of an MRMC study or AI assistance in this document. The device is a physical medical device (catheter), not an AI/software device that would involve human readers interpreting AI output.

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

This information is not applicable/provided. The device is a physical medical device, not an algorithm.

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

For the biocompatibility and design verification (performance bench testing), the "ground truth" would be the established international standards (ISO 10993-1) and internal design specifications and requirements, as well as the performance of the predicate device (K221986).
For animal testing, the "ground truth" for safety, usability, and scoring performance would be observed physiological responses, usability metrics, and observable effects on the treated vessels within the animal models. No mention of expert consensus, pathology, or outcomes data specifically as "ground truth" is made for the animal study.

8. The sample size for the training set

This information is not applicable/provided. The device is a physical medical device, not a machine learning model that requires a training set.

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

This information is not applicable/provided for the same reason as point 8.

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