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Micro Prime Delivery Lines are indicated for use to convey arterial blood and cardioplegia with minimal prime volume in the extracorporeal circuit.

Micro Prime Delivery Lines minimize the blood prime volume in the extracorporeal circuit. For pediatric cardiopulmonary bypass, where excessive priming volume can increase surgical risk, Micro Prime delivery lines offer a distinct advantage. Micro Prime Delivery Lines consist of a dual lumen extrusion: a round "blood" lumen used to convey blood to/from the patient, and a crescent shaped "occlusion" lumen which surrounds the blood lumen, and is used to purge excess prime volume from the blood lumen.

In use, both lumens are initially primed with saline. Once the tubing has been primed, the occlusion lumen is pressurized with additional saline, collapsing the blood lumen and purging excess priming fluid from the blood lumen. Releasing the pressure from the occlusion lumen causes the blood lumen to re-open to its normal shape. In this manner, Micro Prime Delivery Lines regligible blood volume to prime as compared to conventional delivery lines.

The provided text describes a 510(k) summary for the Micro Prime Delivery Lines, a medical device. The summary outlines the device's description, indications for use, and a summary of testing conducted to demonstrate its safety and effectiveness. However, it does not explicitly state "acceptance criteria" in a tabulated format or provide a detailed study report that directly maps device performance against predefined criteria in a way that allows for a direct comparison with specific quantitative thresholds.

Instead, the document describes the types of tests performed and the nature of their conclusions, indicating that the device met functional requirements and performed comparably or better than predicate devices.

Based on the provided text, here's a breakdown of the requested information:

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

The document does not provide a formal table of acceptance criteria with numerical targets. Instead, it describes general successful outcomes and comparability to predicate devices. The "reported device performance" is descriptive rather than quantitative for specific criteria in many instances.

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

• Sample Size for Blood Trauma/Pressure Drop Test: "five 3/16" ID Micro Prime delivery tubes and five 3/16" ID conventional extracorporeal delivery tubes"
• Data Provenance: Not explicitly stated (e.g., country of origin). The description of the tests ("conducted functional testing," "assessed over a 6-hour period using bovine blood") suggests these were prospective bench tests or in-vitro tests rather than human clinical data. The use of "bovine blood" explicitly indicates an animal-derived sample for the blood trauma study.

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 as the studies described are primarily functional, mechanical, and biocompatibility bench/in-vitro tests rather than studies requiring expert interpretation (e.g., image analysis, clinical diagnosis). The "ground truth" for these tests would be objective measurements (e.g., plasma hemoglobin levels, pressure readings, visual inspection for package integrity).

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

This section is not applicable for the type of bench and in-vitro testing described, which relies on objective measurements rather than human reader adjudication of 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 section is not applicable. The device is a physical medical tubing product, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to AI assistance for human readers would not be relevant.

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 tubing product and not a software or algorithm-based device.

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

The ground truth for the various tests described was based on:

• Functional measurements: Objective measurements of device performance (e.g., successful purging of prime volume, pressure readings, mechanical integrity).
• Biocompatibility standards: Reference to Device Master File for silicone and established biocompatibility testing protocols.
• Laboratory assays: For blood trauma, objective measurement of plasma hemoglobin, white blood cell count, and platelet count in bovine blood.
• Physical inspection: For package integrity.
• Statistical comparison: Performance compared to conventional/predicate devices using statistical hypothesis testing.

8. The sample size for the training set

This section is not applicable. The provided text describes studies for a physical medical device, not a machine learning or AI algorithm that requires a "training set."

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

This section is not applicable, as there is no training set for this type of device.

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