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The NMI Retrograde Cardioplegia Cannulae-RCCS are intended for use in perfusing blood or Cardioplegia solutions via the coronary sinus during cardiopulmonary surgery.

The NMI Retrograde Cardioplegia Cannulae are fabricated with polyvinyl chloride bodies (PVC) and polyurethane balloon cuffs, polycarbonate/polyethylene stopcocks, polypropylene clamps, PVC female luer connectors, and stainless steel guidewires. The features of the device include: self-inflating cuff, pressure monitoring port with 3-way stopcock on jumen extension, suture ing. and 14 French size. The cannulae are placed in the coronary sinus in order to infuse cardioplegia in a retrograde fashion to the myocardium. This practice both arrests the heart and preserves metabolic function during surgery.

The provided document, K961717, describes the NMI Retrograde Cardioplegia Cannula-RCCS and its substantial equivalence to the Research Medical, Inc. Retrograde Cardioplegia Cannula # K880103. The study detailed is primarily focused on bench testing and material performance rather than clinical efficacy involving human readers or sophisticated algorithms. Therefore, many of the requested fields related to clinical studies, human readers, ground truth, and AI performance are not applicable.

Here's the information derived from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally demonstrated by the NMI cannulae's performance being comparable to or better than the RMI cannulae or by meeting specific physical/material standards.

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

• Sample Size: Not explicitly stated as a numerical sample size. The testing appears to involve a limited number of manufactured devices for functional testing and material analysis.
• Data Provenance: The data is generated from retrospective bench testing of manufactured devices, comparing the NMI cannulae to a predicate device (Research Medical, Inc. Retrograde Cardioplegia Cannula # K880103). The country of origin of the data is not specified but is implicitly associated with Naltiac Medical, Inc. in Dallas, TX, USA.

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

• Not Applicable. This study does not involve human expert interpretation of data to establish a ground truth. It focuses on physical and material performance metrics evaluated through laboratory testing.

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

• Not Applicable. There is no adjudication method described as the study involves objective physical measurements and material 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

• Not Applicable. This is not a study involving human readers or AI assistance. It's a medical device bench testing and substantial equivalence submission.

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

• Not Applicable. There is no algorithm or AI component to this medical device.

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

• Objective Measurement Standards / Predicate Device Performance: The "ground truth" or reference for performance is established by objective engineering and safety standards (e.g., ANSI/HIMA MD70.1-1983, ASTM F1140-88, ASTM 40169, USP Pyrogen test, Tripartite Biocompatibility Guidance) and by the functional performance ranges observed in the predicate device.

8. The sample size for the training set

• Not Applicable. There is no "training set" in the context of an algorithm or AI. The device is a physical medical instrument.

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

• Not Applicable. As there is no training set for an algorithm, there is no ground truth established for one.

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The NMI Antegrade Cardioplegia Cannulae are intended to be used to deliver cardioplegia solutions to the heart or venting cardioplegia away from the heart via the ascending aora. The cannulae may also be use to aspirate air from the ascending aorta.

The NMI Antegrade Cannulae are manufactured in vented and non-vented and non-vented 12 and 14 gauge. The devices consist of a PVC catheter body with optional vent line, radiopaque flexible PVC tip, stainless steel needle stylet, vent line adapter, polypropylene pinch clamp, PVC suture ring and PVC female luer lock connector.

This document describes the NMI Antegrade Cardioplegia Cannulae, a medical device intended to deliver cardioplegia solutions to the heart or vent them away, and to aspirate air from the ascending aorta. The provided text primarily establishes substantial equivalence to a predicate device and presents performance data from functional testing.

Based on the information provided, here's an analysis of the acceptance criteria and the study proving the device meets them:

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

The document does not explicitly state "acceptance criteria" as pass/fail thresholds. Instead, it provides performance ranges for the NMI Cannulae and compares them directly to the predicate DLP Cannulae. The implicit acceptance criterion appears to be that the NMI device performs comparably or better than the predicate device across various functional tests.

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

The document does not specify the sample size used for the functional testing of the NMI Cannulae or the predicate device. It also does not provide information on the data provenance (e.g., country of origin, retrospective or prospective nature). The testing appears to be laboratory-based functional testing rather than clinical study data.

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)

This section is not applicable to the provided document. The data presented is from functional engineering tests, not a study requiring expert-established ground truth for a test set (like image analysis or clinical diagnosis).

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

This section is not applicable to the provided document, as the testing involves objective measurements of physical properties rather than subjective interpretations requiring 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

This section is not applicable to the provided document. The device is a physical medical instrument (cardioplegia cannula), not an AI diagnostic or assistive technology.

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

This section is not applicable as the device is a physical medical instrument.

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

The "ground truth" for the functional tests is based on objective, quantifiable physical properties and established engineering standards. For example, pressure drop measurements are objective readings, and compliance with standards like ANSI/HIMA MD70.1-1983 and ASTM F1140-88 serves as the "ground truth" for those specific tests. There is no biological or diagnostic ground truth (like pathology or expert consensus) involved in these functional tests.

8. The sample size for the training set

This section is not applicable. The document describes a physical medical device and its functional testing, not a machine learning model that requires a training set.

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

This section is not applicable for the same reason as point 8.

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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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