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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 X-Suit NIR® Biliary Metallic Stent is indicated for palliation of malignant strictures in the biliary tre.

Not Found

This document is a 510(k) premarket notification letter from the FDA for a medical device called the X-Suit NIR® Biliary Metallic Stent. It does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment. This type of FDA letter is an approval for market, not a study report.

Therefore, I cannot provide the requested information from the given text. The document states "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent...". This means the device was found to be substantially equivalent to a legally marketed predicate device, rather than having specific performance criteria and studies detailed in this letter.

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X-Suit NIR® Biliary Metallic Stent is indicated for the palliation of malignant strictures in the biliary tree.

The X-Suit NIR® Biliary Metallic Stent is designed to maintain the patency of biliary ducts obstructed by malignant biliary strictures. The device is comprised of a self-expanding stent, which is pre-loaded on a delivery system. The stent is available in 8 and 10mm labeled diameters, and 40 - 100mm labeled lengths.

Here's an analysis of the provided 510(k) summary regarding the acceptance criteria and the study that proves the device meets them:

The provided text for the X-Suit NIR® Biliary Metallic Stent (K081956) does not contain specific acceptance criteria or details of a clinical study demonstrating device performance against such criteria in the way typically seen for AI/ML devices or clinical trials. Instead, it focuses on demonstrating substantial equivalence to predicate devices through functional testing and adherence to various standards.

Therefore, the requested table of acceptance criteria and device performance, as well as several other points, cannot be fully populated from the given information.

Here's an attempt to extract and infer what's available based on the provided text, and explicitly state what's missing:

Acceptance Criteria and Device Performance Study for X-Suit NIR® Biliary Metallic Stent (K081956)

Summary:
The X-Suit NIR® Biliary Metallic Stent received 510(k) clearance based on substantial equivalence to legally marketed predicate devices. The submission relied heavily on functional (laboratory) testing and adherence to recognized standards and guidance documents rather than a clinical study with specific performance endpoints and acceptance criteria against those endpoints. The primary "performance" demonstrated was that the device met the same performance requirements and was as safe and effective as the predicate devices, as assessed through bench testing and compliance with various specifications.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of this 510(k) summary, specific numerical acceptance criteria (e.g., sensitivity, specificity, accuracy) and their corresponding device performance metrics from a clinical study are not provided. The "acceptance criteria" are broad and relate to meeting a range of functional and material standards to demonstrate equivalence.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not specified. This 510(k) relies on laboratory (functional) testing, not a clinical "test set" in the context of patient data. The "sample size" would refer to the number of devices or components tested in the lab, which is not detailed.
• Data Provenance: The studies were laboratory (bench) tests, not involving patient data from specific countries. The testing was conducted to assess compliance with international standards (ISO, ASTM) and FDA guidance.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Not Applicable. This device clearance did not involve a clinical study requiring experts to establish ground truth on patient cases. The evaluation was based on engineering and material standards, functional performance, and regulatory compliance.

4. Adjudication Method for the Test Set

• Not Applicable. No clinical test set requiring adjudication was used.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No. An MRMC comparative effectiveness study was not done. The submission focused on demonstrating substantial equivalence to existing devices through a combination of engineering, material, and functional bench testing, rather than a clinical trial comparing performance with human readers (with or without AI assistance).

6. Standalone (Algorithm Only) Performance Study

• Not Applicable. This is a physical medical device (stent), not an algorithm or AI software. Therefore, no standalone algorithm performance study was conducted.

7. Type of Ground Truth Used

• Engineering Specifications and Standard Compliance: The "ground truth" for this submission was largely defined by the established performance characteristics of the predicate devices, along with the requirements laid out in various international standards (ISO, ASTM) and FDA guidance documents related to material properties, biocompatibility, sterility, and functional performance (e.g., expansion properties, resistance to fracture, MRI safety).

8. Sample Size for the Training Set

• Not Applicable. As a physical medical device, there is no "training set" in the context of machine learning. The design and development of the stent would follow traditional engineering and R&D processes, using specifications and prototypes, not patient data for algorithm training.

9. How the Ground Truth for the Training Set Was Established

• Not Applicable. (See point 8).

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The NIR Biliary Stent is indicated for use in the treatment of biliary strictures produced by malignant neoplasms.

The proposed NIR™ Biliary Stent is a balloon expandable stent designed to be used with a balloon dilatation catheter. The delivery catheter facilitates transhepatic access to the biliary tree and the stent is designed to maintain luminal patency of biliary strictures produced by malignant neoplasms.

The provided text describes a medical device, the NIR™ Biliary Stent, and its FDA clearance (K973174). However, it does not contain information related to acceptance criteria, device performance metrics, or a study evaluating the device against such criteria.

The document details:

• The device's name and manufacturer.
• Its classification and predicate devices.
• A brief description of its intended use (maintaining luminal patency of biliary strictures produced by malignant neoplasms).
• A general statement about safety and performance, mentioning "Functional and integrity bench testing and Biocompatibility testing" were performed and supported substantial equivalence.

Therefore, I cannot fulfill your request for information regarding acceptance criteria and a study proving the device meets them from the provided text. The document states that "data supported the substantial equivalence of the NIRTM Biliary Stent to the predicate devices," but it does not elaborate on what that data was, what the acceptance criteria were, or the specifics of any studies.

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