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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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The NC Emerge Over-The-Wire (OTW) and NC Emerge Monorail (MR) PTCA Dilatation Catheters are indicated for the balloon catheter dilatation of the stenotic portion of a native coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion in patients with atherosclerosis.
NC Emerge Over-The-Wire and NC Emerge Monorail PTCA Dilatation Catheters (balloon models 2.00-5.00 mm) are also indicated for the post-delivery expansion of balloon expandable stents (bare metal and drug-eluting).

The NC Emerge PTCA Dilatation Catheters are sterile, single-use, intravascular medical devices. The catheter consists of a shaft with a balloon near the distal tip. The balloon is designed to provide an inflatable segment of known diameter and length at recommended pressures. The NC Emerge PTCA Dilatation Catheter is offered in both Monorail (MR) and Over-The-Wire (OTW) platforms. There are two (2) radiopaque marker bands located under the balloon to aid in positioning the system during the procedure. Coatings are applied to the balloon and catheter to enhance insertion and withdrawal performance.

The provided text describes a 510(k) premarket notification for the NC Emerge™ PTCA Dilatation Catheter. It focuses on demonstrating substantial equivalence to existing predicate devices through bench testing and biocompatibility testing. The document explicitly states "No new safety or performance issues were raised during the testing and, therefore, these devices may be considered substantially equivalent to the predicate devices."

However, the provided text does not contain the specific acceptance criteria, reported performance values, or detailed study results (like sample sizes, ground truth establishment, or expert information) that would typically be found in a comprehensive study report. The "Performance Data" section lists the types of tests performed but does not provide quantitative results or explicit acceptance criteria for those tests.

Therefore, many of the requested details cannot be extracted from this document.

Here's a breakdown of what can and cannot be provided based on the input:

1. A table of acceptance criteria and the reported device performance

• Cannot be provided definitively from the text. The document lists the types of performance tests conducted (e.g., Effective Length, Rated Burst Pressure, Balloon Fatigue), but it does not specify the acceptance criteria or quantitative reported performance values for these tests. For example, it doesn't state what the accepted range for "Effective Length" is or what the measured effective length was. It only concludes that the tests supported substantial equivalence.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• Cannot be provided from the text. The document mentions "bench testing and biocompatibility testing were performed" but does not specify the sample sizes used for these tests. It also does not provide information on data provenance (country of origin, retrospective/prospective). This is common for 510(k) summaries, which often abstract away detailed test reports.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

• Not applicable / Cannot be provided from the text. This type of information is relevant for studies involving human physiological data or image interpretation where expert consensus forms the ground truth. The tests described are "bench testing" and "biocompatibility testing," which are laboratory tests performed on the device itself, not human subjects. Therefore, the concept of "experts establishing ground truth" in the way described does not apply here.

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

• Not applicable / Cannot be provided from the text. Similar to point 3, adjudication methods are typically used for expert review of subjective data (like medical images or clinical outcomes). The described tests are objective laboratory measurements, so adjudication by experts is not relevant.

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

• No. This device is a PTCA Dilatation Catheter, a physical medical device used in interventional cardiology. It is not an AI-powered diagnostic or assistive tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant to this device.

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

• No. This device is a physical medical device, not an algorithm or AI system. Therefore, a standalone algorithm performance study is not relevant.

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

• Not applicable / Cannot be provided directly as "ground truth" in the requested sense. For the bench and biocompatibility tests, the "ground truth" would be established by physical measurement standards, internationally recognized test methods (e.g., ISO standards), and internal Boston Scientific specifications for device performance. It's not "expert consensus" on an image, for example, but rather adherence to predefined engineering specifications and biological safety standards.

8. The sample size for the training set

• Not applicable / Cannot be provided from the text. Training sets are relevant for machine learning or AI models. This device is a physical medical device, not an AI system. Therefore, there is no "training set" in this context.

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

• Not applicable / Cannot be provided from the text. As explained in point 8, there is no training set for this type of device.

Summary of available information from the text regarding acceptance criteria and study:

The document outlines that the device was subjected to:

• "bench testing"
• "biocompatibility testing"

These tests were performed "according to the requirements of Guidance for Industry and FDA Staff – Class II Special Controls for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters, 08 September 2010."

The types of tests completed are listed under "Performance Data":

Biocompatibility and Chemical Characterization Tests:

• Cytotoxicity
• Sensitization
• Intracutaneous Reactivity
• Acute Systemic Toxicity
• Materials Mediated Pyrogenicity
• USP Physicochemical
• Hemolysis (Direct Contact)
• Hemolysis (Extract Method)
• Complement Activation
• Coagulation
• In Vitro Hemocompatibility

In-vitro Performance Tests:

• Effective Length
• Shaft Inner and Outer Diameter
• Crossing Profile
• Balloon Preparation, Deployment, and Retraction
• Withdrawal into a Guide Catheter
• Rated Burst Pressure
• Balloon Fatigue (Repeat Inflations)
• Balloon Compliance
• Balloon Inflation/Deflation Time
• Catheter Bond Strength Tensile
• Tip Pull Test
• Flexibility and Kink
• Torque Strength
• Radiopacity
• Coating Integrity
• Particulate Evaluation
• Rated Burst Pressure in a Stent
• Balloon Fatigue (in Stent)
• Kissing Balloon Compatibility

Conclusion: "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, these devices may be considered substantially equivalent to the predicate devices."

In essence, the "study" is a series of laboratory tests demonstrating that the NC Emerge PTCA Dilatation Catheter performs comparably to its predicate devices in accordance with regulatory guidance and relevant standards, ensuring its safety and effectiveness. The specific quantitative acceptance criteria and detailed performance values are not disclosed in this summary document.

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