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The NMI Vein Graft Perfusion Set is intended to be used during a cardiopulmonary bypass procedure to connect multiple coronary cannulae to a single infusion line.

The NMI Vein Graft Perfusion Set is fabricated with PVC alloy tubing, PVC Quad fitting, polypropylene pinch clamp, PVC female luer connector, and ABS male luer connector. The features of the device include: one 3 1/4 inlet leg with female luer port and white pinch clamp, three 9 3/4 in. outlet legs with red pinch clamps terminating in male luer lock connectors, one 3 1/4 in. outlet leg with blue pinch clamp terminating in a male luck, and soft flexible tubing on legs, .090 1.D., and 3/16 O.D.

Here's an analysis of the provided text regarding the acceptance criteria and study for the NMI Vein Graft Perfusion Set:

General Statement: The provided text describes the safety and effectiveness of a medical device (NMI Vein Graft Perfusion Set) by comparing it to an already approved predicate device (DLP Multiple Perfusion Set). The "study" here is primarily focused on functional and material testing to demonstrate substantial equivalence, rather than a clinical trial with patient outcomes or a multi-reader study.

Acceptance Criteria and Reported Device Performance

Study Details

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

   • The document does not specify the exact sample size for each functional and material test mentioned (e.g., how many devices were tested for pressure drop, leak tests, bond strength, etc.).
   • Data Provenance: The tests appear to be laboratory-based, in-house testing conducted by Naltiac Medical, Inc. or a contracted testing facility. There is no indication of country of origin for specific "data" beyond the manufacturer's location (Dallas, TX). The results are based on prospective testing of the NMI device and comparison with the predicate DLP device.

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

   • This type of information is not applicable to the data presented. The "ground truth" here is defined by objective engineering and material standards (e.g., meeting a specific psi for leak test, exceeding a certain tensile strength, complying with ISO/ASTM standards). There are no human experts "reading" or interpreting results in a subjective sense that would require qualification; rather, technicians and engineers would perform the tests according to established protocols.

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

   • None. Adjudication methods like 2+1 or 3+1 are typically used for subjective assessments where multiple experts review and agree on a "ground truth" (e.g., reading medical images). The tests described for the NMI Vein Graft Perfusion Set are objective, measurable physical and chemical tests against predefined criteria.

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:

   • No. An MRMC study is completely irrelevant to this device and the type of evaluation presented. This device is a perfusion set, not an imaging AI or diagnostic tool that involves human interpretation of data.

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

   • No. This is not an AI algorithm or software device. The "standalone" performance refers to the physical and functional performance of the device itself against established engineering and material standards, which is what the report details (e.g., pressure drop ranges, leak tests, bond strength).

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

   • The "ground truth" used for this device's evaluation is based on objective engineering and material test standards, established regulatory guidance (e.g., Tripartite Biocompatibility Guidance), and comparison to the performance of a predicate device. Examples include:
     • Compliance with ASTM standards (F1140-88, 40169).
     • Compliance with ANSI/HIMA MD70.1-1983.
     • Meeting specific physical thresholds (e.g., 0.4 lb tensile strength, no leaks at 10 psi).
     • Achieving a specific Sterility Assurance Level (SAL 10⁻⁶).
     • Meeting non-pyrogenicity criteria per USP.

7. The sample size for the training set:

   • Not applicable. This document describes the testing of a physical medical device, not a machine learning model. Therefore, there is no "training set."

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

   • Not applicable. As there is no training set, this question is not relevant.

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