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The pump is intended for use only with Stöckert Instrumente Centrifugal Pump Consoles in cardiopulmonary bypass procedures for periods of up to six hours. Refer to the console operator's manual for console operating procedures.

The pump has not been qualified through in vitro, in vivo, or clinical studies for long term use (i.e., longer than six hours) as a bridge to transplant, for pending recovery of the natural heart or extracorporeal membrane oxygenation (ECMO).

The Cobe Cardiovascular Revolution Pump with PC Coating is an extracorporeal blood pump that is provided sterile, single use only, with non-pyrogenic fluid pathways, and is not to be resterilized by the user. It may be sold as a stand-alone device or as a component of a customized heart/lung pack.

The Revolution Centrifugal Blood Pump with PC Coating utilizes a rotating, vaned impeller design to move blood by centrifugal force. Blood contact surfaces of the PC coated Revolution have been coated with phosphorylcholine to improve blood compatibility, resulting in reduced platelet adhesion on the coated surfaces.

The provided text is a 510(k) summary for a medical device (COBE Cardiovascular Revolution® Centrifugal Blood Pump with PC Coating) seeking substantial equivalence to a predicate device. It primarily focuses on regulatory approval based on material modification rather than a complex AI-based system. Therefore, many of the requested categories for AI-driven device studies, such as sample sizes for test/training sets, expert qualifications, and MRMC studies, are not applicable or cannot be extracted from this document.

However, I can extract information related to the acceptance criteria and the study performed to demonstrate substantial equivalence for this type of device.

1. Table of Acceptance Criteria and Reported Device Performance

For this medical device, the "acceptance criteria" are implicitly defined by demonstrating substantial equivalence to a predicate device, particularly concerning performance characteristics and blood compatibility after the addition of a PC coating. The "performance" is assessed through in-vitro laboratory tests comparing the coated device to the uncoated predicate.

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

The document states "In-Vitro laboratory tests were performed." It does not specify the sample size of devices or the number of runs/experiments conducted. The data provenance is laboratory testing by COBE Cardiovascular, Inc. (manufacturer), presumably performed in the USA. Given this is a device performance test, it is by nature "prospective" for the devices being tested.

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

This information is not applicable and not provided. The "ground truth" for a physical device's performance in in-vitro tests typically comes from established experimental protocols and measurement standards rather than expert consensus on medical images or diagnostic interpretations.

4. Adjudication method for the test set

This information is not applicable and not provided. Adjudication methods are typically relevant for human interpretation tasks or clinical endpoints where differing opinions need to be resolved.

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 information is not applicable and not provided. This is a physical medical device, not an AI-based diagnostic tool.

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

This information is not applicable and not provided. This is a physical medical device, not an algorithm.

7. The type of ground truth used

For substantial equivalence of a physical device, the "ground truth" would be the established performance characteristics and safety profile of the predicate device (uncoated Revolution Centrifugal Blood Pump) as demonstrated through its original 510(k) submission (K011835) and relevant industry standards. The in-vitro tests for the new device would be compared against these benchmarks.

8. The sample size for the training set

This information is not applicable and not provided. This is a physical medical device, not a machine learning model.

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

This information is not applicable and not provided. This is a physical medical device, not a machine learning model.

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