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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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The COBE® REVOLUTION™ Centrifugal Blood Pump is intended to be used with a Stöckert Instrumente GmbH Centrifugal Pump console in cardiopulmonary bypass procedures for periods of up to six hours. The pump has not been qualified through in vitro, in vivo, or clinical studies for long term use (i.e., greater than six hours) as a bridge to transplant, for pending recovery of the natural heart, or extracorporeal membrane oxygenation (ECMO) procedures.

The COBE® Revolution™ Centrifugal Blood Pump is an extracorporeal blood pump that utilizes a rotating vaned impeller design to move blood by centrifugal force. The device is provided sterile with a nonpyrogenic fluid pathway, and is for single use only. It is indicated for use with a Stockert Instrumente GmbH Centrifugal Pump console in cardiopulmonary bypass procedures for periods of up to six hours. The device has not been qualified for longterm use (greater than six hours) as a bridge to transplant, for pending recovery of the natural heart or extracorporeal membrane oxygenation (ECMO). The Revolution Pump consists of a rotating vaned impeller within a pump housing. The pump housing has two components, a top and bottom case, and features a central, single-barbed, 3/8" inlet port and tangential, double-barbed, 3/8" outlet port. The vaned impeller is molded onto a steel shaft that supports it at its axis of rotation, with the shaft rotating on a bearing at each end. The device contains a multi-pole magnet that is fully enclosed within the magnet housing and thus does not contact the blood pathway. The magnet is designed to magnetically couple with the pump drive unit of the Stockert Instrumente GmbH Centrifygal Pump console. Rotation of the magnet causes the impeller to rotate and pump blood via centrifugal force.

The provided 510(k) summary (K011835) describes a medical device, the COBE® Revolution™ Centrifugal Blood Pump, and its claim of substantial equivalence to a predicate device, the Medtronic BP-80 BioPump® Centrifugal Blood Pump. However, it does not contain information about a study with specific acceptance criteria and detailed device performance metrics in the way that would typically be presented for an AI/ML powered device.

Instead, the submission focuses on comparing the technical characteristics of the new device to the predicate device to demonstrate substantial equivalence, which is a different type of evaluation. The "in-vitro test data" mentioned merely supports the claim of substantial equivalence, not a detailed performance study against specific acceptance criteria for an AI algorithm.

Therefore, many of the requested sections (2-7, 9) cannot be answered from the provided text as they pertain to AI/ML device studies that are not present.

Here's an attempt to answer the questions based only on the provided text, highlighting what information is available and what is not:

Acceptance Criteria and Study Information (Based on K011835)

This 510(k) submission establishes the substantial equivalence of the COBE® Revolution™ Centrifugal Blood Pump to the Medtronic BP-80 BioPump® Centrifugal Blood Pump. The "acceptance criteria" here are implicitly related to demonstrating that the new device performs comparably to the predicate device across critical functional and design parameters, rather than meeting specific performance thresholds for an AI algorithm.

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

The submission does not explicitly state "acceptance criteria" in the format of predefined thresholds for performance metrics. Instead, it compares the characteristics of the new device to the predicate. The "reported device performance" is essentially the listed characteristics of the COBE Revolution Pump. The underlying acceptance criterion for the 510(k) process is "substantial equivalence" to the predicate.

Note: The implicit acceptance criteria for substantial equivalence mean that the differences in these parameters should not raise new questions of safety or effectiveness.

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 mentions "In-vitro test data" but does not specify the sample size, data provenance, or whether the study was retrospective or prospective. It is an in-vitro comparison, not a clinical study with patients.

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 information is not provided in the 510(k) summary. The "ground truth" for this type of device comparison would be established engineering and performance standards, not expert evaluation of AI output.

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

This information is not provided.

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

No such study was conducted or reported in this 510(k) submission, as it is not an AI/ML powered device.

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

Not applicable, as this is not an AI/ML powered device.

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

The "ground truth" in this context is the established performance characteristics of the predicate device and engineering standards for blood pumps. It is not dependent on expert consensus, pathology, or outcomes data in the way an AI/ML diagnostic or prognostic device would be.

8. The sample size for the training set

Not applicable, as this is not an AI/ML powered device and therefore has no "training set."

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

Not applicable, as there is no training set for this device.

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