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The Glider PTCA Balloon Catheter is indicated for balloon dilatation of the stenotic portion of coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.

The Glider PTCA Balloon Catheter is a torqueable, rapid-exchange, balloon percutaneous transluminal coronary angioplasty (PTCA) catheter. The device is compatible with commonly used accessories including standard 0.014" coronary guide wires and 6F guide catheters. Overall catheter length is approximately 135 cm. The distal end of the catheter has a semi-compliant balloon that expands to known diameters and lengths at specific pressures. The balloon has one or two radiopaque markers to assist with positioning. The braidreinforced shaft and the lubricious hydrophilic coating assist torque transmission. The proximal end of the device is a common PTCA catheter design consisting of a hypotube connected to a plastic hub and strain relief. The hub is used to inflate the balloon and the luer connector is compatible with standard inflation devices. A second lumen within the catheter, intended for guidewire use, extends from the rapid exchange port to the distal tip. The Glider PTCA Balloon Catheter is supplied sterile and intended for single use.

The provided text describes the 510(k) summary for the Glider™ PTCA Balloon Catheter. This device is a medical instrument and its evaluation focuses on physical performance and biocompatibility, not on AI/ML algorithm performance. Therefore, many of the requested categories related to AI/ML studies (such as sample sizes for test/training sets, ground truth establishment for AI, expert qualifications, adjudication methods, and MRMC studies) are not applicable to this document.

Here's the information that can be extracted from the provided text, adapted for a medical device that doesn't involve AI/ML:

Acceptance Criteria and Device Performance

The device performance was evaluated against the "FDA Guidance Class II Special Controls for Certain Perculaneous Transluminal Coronary Angioplasty (PTCA) Catheters (September 8, 2010)." This guidance document specifies the acceptance criteria for the various performance tests. The given document states that the device was subjected to these tests and no new questions of safety or effectiveness were identified, implying that the device met the established acceptance criteria.

Study Details (Non-AI/ML focused):

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

   • The document does not explicitly state the sample sizes (e.g., number of catheters tested) for each physical performance and biocompatibility test. It only lists the types of tests performed.
   • Data Provenance: The testing was presumably conducted by TriReme Medical, Inc. or a contracted lab, as part of their submission to the FDA. The country of origin for the data is not specified, but the submitter is based in Pleasanton, CA, U.S.A. The studies are by nature prospective, as the device was manufactured and then tested to demonstrate performance.

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

   • This concept is not applicable to a physical medical device like a PTCA catheter. "Ground truth" in this context would refer to the objective, measurable outcomes of the physical tests (e.g., actual burst pressure, measured dimensions). These are determined by laboratory equipment and standardized procedures, not by expert consensus in an observational or diagnostic context.

3. Adjudication method for the test set:

   • Not applicable for physical performance and biocompatibility testing. Results are typically quantitative and objective measurements against predefined specifications.

4. 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 as this is a physical medical device, not an AI/ML diagnostic or assistive tool.

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

   • Not applicable as this is a physical medical device, not an AI/ML algorithm.

6. The type of ground truth used:

   • For physical performance tests, the "ground truth" is established by the objective measurement of physical properties (e.g., direct measurement of dimensions, pressures, forces) against engineering specifications and regulatory guidance.
   • For biocompatibility tests, the "ground truth" is established by laboratory assays and biological testing outcomes (e.g., observation of cell viability, measurement of hemolysis rates) against established biocompatibility standards and limits.

7. The sample size for the training set:

   • Not applicable as this is a physical medical device. The concept of a "training set" is relevant for AI/ML models. For a physical device, development typically involves iterative design, prototyping, and testing, but not a "training set" in the AI sense.

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

   • Not applicable as this is a physical medical device.

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