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The Tamarin Blue PTCA RX Dilatation Catheters are indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion.

The Tamarin Blue PTCA RX Dilatation Catheter is a standard Rapid Exchange (RX) PTCA catheter with a single lumen proximally, a dual lumen distally, a semi-compliant inflatable balloon and a soft, tapered distal tip to aid in crossing tight stenoses. One lumen of the catheter's dual lumen is used for inflation and deflation of the balloon, and the other lumen allows guide wire access through the distal part of the catheter. The maximum recommended guide wire diameter is 0.014". A luer lock fitting (hub) allows connection with an inflation device. Two radiopaque markers on the guide wire lumen tubing provide visual reference points for balloon positioning across the stenosis. A hydrophilic coating has been applied on the distal portion of catheter i.e., up to the RX port, to improve catheter pushability. The balloon material expands to a known diameter at a specific pressure as defined in the compliance table supplied with the catheter.

The device is supplied sterile and intended for one-time use.

This document is a 510(k) summary for the Tamarin Blue PTCA RX Dilatation Catheter (K210012). It details the device's comparison to predicate and reference devices and non-clinical testing performed to establish substantial equivalence.

Here's an analysis to extract the requested information, although it's important to note that this document pertains to a medical device (catheter) and not an AI/ML-driven diagnostic or image analysis device, which are typically the subject of the detailed acceptance criteria and study design questions you've posed. Therefore, many of the requested fields related to AI/ML performance, ground truth establishment by experts, MRMC studies, training sets, etc., will not be applicable or present in this type of submission.

The information consistently aligns with a submission for a physical medical device, not a software/AI device.

Here's the closest interpretation of your request based on the provided document:

Device Name: Tamarin Blue PTCA RX Dilatation Catheter

Device Type: Medical Device (PTCA Dilatation Catheter)

Acceptance Criteria and Device Performance:

The primary "acceptance criteria" for this device, as detailed in a 510(k) submission, revolve around demonstrating substantial equivalence to a previously cleared predicate device. This is typically achieved through non-clinical bench testing to ensure the device performs as intended and meets established safety and performance standards for its class. The document explicitly states that the technological characteristics (components, design, sterilization method, shelf life, operating principle) are identical to the predicate device, with the only notable difference being the addition of a hydrophilic coating, which was tested and shown not to raise new questions of safety or effectiveness.

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

Since this is a physical medical device, "acceptance criteria" are not reported as classical sensitivity/specificity/AUC metrics for a diagnostic algorithm. Instead, they are engineering and performance benchmarks validated through bench testing. The document states that the device "met all acceptance criteria."

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

• Sample Size: Not explicitly stated as a "sample size" in the context of clinical studies for diagnostic accuracy. The non-clinical bench testing would involve a certain number of manufactured devices for each test (e.g., a specific batch size for burst pressure testing, a number of devices for fatigue testing). These numbers are not detailed in this summary.
• Data Provenance: The testing is non-clinical bench testing, meaning it's performed in a laboratory, not from patient data. Therefore, "country of origin of the data" and "retrospective or prospective" are not applicable.

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

This concept is not applicable here as the "ground truth" for a physical device is its adherence to engineering specifications and performance standards, validated through objective bench testing. There are no "experts" establishing ground truth in the sense of medical image interpretation for diagnosis.

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

Not applicable. This is for objective bench testing, not subjective human interpretations that require adjudication.

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 is for an AI/ML-driven diagnostic/image analysis device. This product is a physical medical catheter.

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

Not applicable. This is a physical medical catheter, not an algorithm.

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

The "ground truth" for this device is based on engineering specifications, established performance standards (e.g., burst pressure limits), and material properties. Compliance is demonstrated through objective bench testing.

8. The sample size for the training set:

Not applicable. There is no AI/ML "training set" for this physical device.

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

Not applicable. There is no AI/ML "training set" for this physical device.

Summary of the Study:

The study proving the device meets acceptance criteria is a non-clinical bench testing program. The purpose of this testing was to demonstrate that the Tamarin Blue PTCA RX Dilatation Catheter (K210012), with the addition of a hydrophilic coating, is substantially equivalent to its predicate device (Tamarin Blue PTCA RX Dilatation Catheter, K112735) and equivalent to a reference device (Filao NC RX PTCA Dilatation Catheter, K141933) for the coating aspects.

The testing evaluated various performance characteristics, including:

• Coating Inspection
• Coating Integrity (Performance and Durability)
• Balloon preparation, deployment and retraction
• Balloon Rated Burst
• Balloon Fatigue
• Balloon compliance
• Balloon inflation/deflation
• Particulate

The conclusion from these tests was that the hydrophilic coating performed as intended, did not impact the functionality of the device, and that the subject device "met all acceptance criteria" and is biocompatible. The technological characteristics, intended use, and indications for use were found to be identical or substantially similar, with any differences not raising new questions of safety or effectiveness.

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The Tamarin Blue® RX PTCA Dilatation Catheters are indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion.

The Tamarin Blue® PTCA RX Dilatation Catheter is a standard Rapid Exchange (RX) PTCA catheter with a single lumen proximally, a dual lumen distally, a semi-compliant inflatable balloon and a soft, tapered distal tip to aid in crossing tight stenoses. One lumen of the catheter's dual lumen is used for inflation and deflation of the balloon, and the other lumen allows guide wire access through the distal part of the catheter. The maximum recommended guide wire diameter is 0.014". A luer lock fitting (Hub) allows connection with an inflation device. Two radiopaque markers on the guide wire lumen tubing provide visual reference points for balloon positioning across the stenosis. The balloon material expands to a known diameter at specific pressure as defined in the compliance table supplied with the catheter.

Here is an analysis of the provided 510(k) summary regarding the Tamarin Blue® PTCA RX Dilatation Catheter, focusing on acceptance criteria and the supporting study information:

Acceptance Criteria and Device Performance

The provided document describes a medical device, the Tamarin Blue® PTCA RX Dilatation Catheter, and its non-clinical testing. It asserts that the device met all the predetermined acceptance criteria of design verification and validation. However, the document does not explicitly list the acceptance criteria values or the specific reported device performance values for each test. It only states that the device successfully met these unlisted criteria.

Therefore, a table with specific acceptance criteria and reported performance cannot be created from the provided text. The document broadly states the types of tests performed.

Study Information

The provided document describes a non-clinical study involving various in vitro tests to demonstrate the safety and effectiveness of the device. It is not a clinical study involving human subjects or AI algorithms.

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

   • Sample Size: Not specified for any of the individual non-clinical tests. The document only lists the types of tests performed.
   • Data Provenance: The tests are non-clinical (laboratory-based) and conducted according to international standards (ISO, ASTM) and US federal regulations (21 CFR 58 GLP). The country of origin of the data is not explicitly stated, but the sponsor is Natec Medical Ltd. from Mauritius.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This document describes non-clinical engineering and materials testing, not a study requiring expert consensus for diagnostic ground truth.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. Non-clinical physical and chemical tests have predefined objective pass/fail criteria, not subjective interpretation requiring adjudication.

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. No MRMC or AI-related study was performed or mentioned. This device is a physical medical device (catheter), not an AI diagnostic tool.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For non-clinical tests, the "ground truth" is typically defined by pre-established engineering specifications, material standards, and regulatory requirements. For example, a bond strength test would have a minimum force requirement (ground truth) that the device must meet. Biocompatibility has specific toxicological thresholds.

7. The sample size for the training set: Not applicable. There is no training set mentioned as this is not an AI/machine learning study.

8. How the ground truth for the training set was established: Not applicable. There is no training set.

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