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The PTA Balloon Catheter family is intended for balloon dilatation of lesions in the peripheral vasculature, including the iliac, femoral, popliteal, infra-popliteal, and renal arteries. NOT for use in the coronary or cerebral vasculature.

All of the devices in the PTA Balloon Catheter family, including the GliderXtreme PTA Balloon Catheter and the GliderfleX PTA Balloon Catheter consist of a standard balloon dilatation catheter on a braided shaft with or without a hypotube and an atraumatic, tapered and beveled tip. The devices are compatible with commonly used accessories, including standard 0.014" and 0.018" guidewires and 5F or 6F introducer sheath (or 6F or 7F guide catheter). Overall catheter lengths are approximately 100 cm to 150cm.

The distal end has a semi-compliant balloon that expands to known diameters (refer to compliance chart) at specific pressures. The balloon contains radiopaque markers to assist with positioning. The shaft is braid reinforced and has a lubricious hydrophilic coating.

The proximal end of the device is a common PTA catheter connected to a plastic hub and strain relief. The hub is used to inflate the balloon; the luer connector is compatible with standard inflation devices.

All PTA Balloon Catheters in the family are supplied sterile and intended for single use only.

The provided document focuses on the mechanical and physical performance of a medical device (PTA Balloon Catheter family) rather than an AI/ML device. Therefore, the questions related to AI/ML specific criteria (such as 'number of experts', 'adjudication method', 'MRMC study', 'standalone performance', 'training set sample size', and 'ground truth for training set') are not applicable to this document.

Here's the information that can be extracted relevant to the performance of the PTA Balloon Catheter:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that "Bench testing was performed to support a determination of substantial equivalence. Results from this testing provide assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use." However, specific quantitative acceptance criteria and the exact reported performance values are not detailed in this summary. Instead, it lists the types of tests performed.

The document concludes that "Performance testing demonstrated that the devices reliably achieved the desired effect and is safe for its intended use. No new questions of safety or effectiveness were identified during device testing."

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

The document mentions "Bench testing was performed" but does not specify the sample sizes used for each test. The tests are in vitro (laboratory bench tests) to assess physical device properties, not clinical data provenance.

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

Not applicable. This is not an AI/ML device requiring human expert ground truth for interpretation of clinical data. The tests are physical performance tests.

4. Adjudication method for the test set

Not applicable. This is not an AI/ML device.

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 is not an AI/ML device.

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

Not applicable. This is not an AI/ML device.

7. The type of ground truth used

The "ground truth" for this device would be established by engineering specifications, standards, and established physical measurement techniques. The tests performed (e.g., burst pressure, fatigue, strength) are quantitative physical performance evaluations against predefined engineering targets, not against clinical expert consensus or pathology.

8. The sample size for the training set

Not applicable. This is not an AI/ML device. There is no "training set."

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

Not applicable. This is not an AI/ML device.

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