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The NC Gallant PTCA Catheter is indicated for:
• Balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion;
• Post-deployment stent expansion.

The NC Gallant is a sterile, single-use, intravascular medical device. The NC Gallant is a double lumen catheter comprising an expandable non-compliant (NC) coronary balloon on a rapid exchange (RX) catheter.

Here's a breakdown of the acceptance criteria and the study information for the Medinol Ltd. NC Gallant PTCA Catheter, based on the provided FDA 510(k) summary:

This device is a Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter, which is typically subject to bench testing and biocompatibility testing to establish substantial equivalence. It's important to note that for this type of device, the "acceptance criteria" are generally met by demonstrating that the device performs comparably to legally marketed predicate devices across a series of established engineering and biocompatibility tests. There isn't typically a "performance metric" in the same way an AI/ML device would have for diagnostic accuracy.

1. Table of Acceptance Criteria and Reported Device Performance

Overall Conclusion: The document states, "The results of these tests provide reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use. No new safety or performance issues were raised during the testing and, therefore, the NC Gallant may be considered substantially equivalent to the predicate devices."

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

The document describes bench testing, biocompatibility testing, and a GLP acute performance study in a porcine model. These types of studies use manufactured devices and animal models, not human patient data in the way an AI/ML diagnostic device would. Therefore, the concept of "sample size for the test set" concerning human patient data or "data provenance" (country of origin, retrospective/prospective) is not directly applicable here.

• Bench Testing: Involves testing multiple units of the manufactured device to various physical and mechanical specifications. The specific number of units tested for each in-vitro test is not detailed in this summary but would be part of the full submission.
• Biocompatibility Testing: Involves testing materials and components according to established standards. The sample sizes for these tests are dictated by the specific ISO standards (e.g., ISO 10993 series) applied.
• Porcine Model Study: This is an animal study. The specific number of animals used is not provided in this summary but would be part of the GLP (Good Laboratory Practice) study report. The document states it's a "Porcine Model."

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

This question is not applicable to this type of medical device submission. Ground truth, in the context of an AI/ML device, refers to a definitive diagnosis or assessment made by human experts or pathology. For a PTCA catheter, performance is evaluated against engineering specifications, biocompatibility standards, and observable outcomes in animal models or clinical trials (though a clinical trial is not described as the primary method for substantial equivalence here beyond the porcine model). The "ground truth" is typically defined by regulatory standards and established scientific methods for testing medical device properties.

4. Adjudication method for the test set

This question is not applicable. Adjudication methods like 2+1 or 3+1 refer to how discrepancies in human expert opinions are resolved to establish a single ground truth, which is relevant for AI/ML diagnostic performance studies. For physical devices like catheters, performance is evaluated by measurable outcomes from tests, not subjective 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

This question is not applicable. An MRMC study is relevant for AI-assisted diagnostic devices where human readers (e.g., radiologists) interpret cases with and without AI. The NC Gallant PTCA Catheter is a physical interventional device, not an AI diagnostic tool.

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

This question is not applicable. This refers to the performance of an AI algorithm independently. The NC Gallant PTCA Catheter is a physical device.

7. The type of ground truth used

For this device, the "ground truth" is established through:

• Engineering specifications and standards: Performance metrics like burst pressure, flexibility, and dimensions are compared against predetermined valid ranges and the performance of predicate devices.
• Biocompatibility standards (e.g., ISO 10993 series): These define acceptable levels of biological response to materials.
• Observations from the GLP acute performance study in a porcine model: This would involve evaluating the device's function, safety, and any tissue reactions in a living system according to predefined criteria for successful deployment and physiological response.

8. The sample size for the training set

This question is not applicable. This refers to AI/ML development. The NC Gallant PTCA Catheter is a physical medical device; it does not involve a training set as an AI algorithm would.

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

This question is not applicable for the same reasons as point 8.

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