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The Glider™ PTCA Balloon Dilatation 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 braid reinforced 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 currently cleared Glider PTCA devices include the 2.5 and 3.0mm diameter balloons in lengths of 4.0, 8.0, and 12.0mm. The intent of this submission is to market an expanded size matrix, including 1.5, 2.0, and 3.5mm diameter balloons and 16 and 20mm lengths for all diameters. Additional shelf-life testing has been conducted to support the expanded sizes in this submission; all other mechanical bench testing on these devices has been previously provided and reviewed by FDA with K111544. There is no other change to the Glider PTCA device from the original submission.

The provided text describes a 510(k) submission for the Glider™ PTCA Balloon Catheter, focusing on its substantial equivalence to predicate devices and the performance testing conducted. It does not describe a study involving AI, human readers, or the establishment of ground truth by experts in the context of an AI device.

Therefore, I cannot provide information on acceptance criteria, reported device performance, sample sizes for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth used, or training set details as they relate to an AI device.

The document details the following for the Glider™ PTCA Balloon Catheter:

1. Acceptance Criteria and Device Performance:

The document lists performance tests conducted, but does not provide specific quantitative acceptance criteria or reported numerical results for each test. Instead, it states that "No new questions of safety or effectiveness were identified during device testing." This implies that the device met the implied acceptance criteria for each test to demonstrate substantial equivalence to the predicate devices.

Biocompatibility Tests listed:

• Hemolysis Assay Direct Contact
• Hemolysis Assay Extract Method
• Platelet & Leucocyte Counts
• Partial Thromboplastin Time
• Thromboresistance
• Complement Activation C3a and SC5b-9 Assay
• MEM Elution Assay with L-929 Mouse Fibroblast Cells (Cytotoxicity)
• Intracutaneous Reactivity Test
• Guinea Pig Maximization Sensitization Test
• Materials Mediated Rabbit Pyrogen Test
• Acute Systemic Injection Test

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

The document does not specify the exact sample size for each performance test. It only states that "all other mechanical bench testing on these devices has been previously provided and reviewed by FDA with K111544." The testing appears to be primarily bench testing conducted on physical devices, not clinical data. The data provenance is not explicitly stated as country of origin, but the submission is from TriReme Medical, Inc. based in California, USA, implying the testing was likely conducted in the USA or under US regulations for medical devices. The nature of these tests classifies them as prospective bench tests on manufactured devices, not retrospective analysis of clinical data.

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

Not applicable. This is a premarket notification for a medical device (PTCA Balloon Catheter), not an AI device that requires expert ground truth for image interpretation or diagnosis. The "ground truth" for these tests would be the design specifications and established engineering/biocompatibility standards.

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

Not applicable. This is a submission for a physical medical device, not an AI device where human adjudication of results is relevant. The "adjudication" for these tests lies in comparing test results against predefined engineering and regulatory standards.

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 document describes a physical medical device (PTCA Balloon Catheter), not an AI-assisted diagnostic or interpretation system.

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):

For the performance testing mentioned, the "ground truth" is based on established engineering standards, device specifications (e.g., balloon diameters at specific pressures, bond strengths), and biocompatibility guidelines outlined in FDA Guidance Class II Special Controls for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters (September 8, 2010). There is no "expert consensus" on clinical cases, pathology, or outcomes data used to establish ground truth for these bench tests.

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. This device does not involve machine learning or a training set.

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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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