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The COBE® SMAR T™ HVR® 4000™ Surface Modified Hardshell Venous Reservoirs are intended to be used in adult surgical procedures requiring cardiopulmonary bypass for periods of up to six hours.

The COBE® SMAR,T™ HVR® 4000™ Surface Modified Hardshell Venous Reservoirs are sterile devices with non-pyrogenic fluid pathways, for single use only, and are not to be resterilized by the user. The devices are open, hardshell, venous blood reservoirs intended to be used during adult cardiac surgical procedures requiring extracorporeal support for periods of up to six hours. Two configurations are available, one with an integral cardiotomy filter and one without the filter.

The filtered version of the COBE® SMAR.T™ HVR® 4000™ Surface Modified Venous Reservoir, in addition to receiving and storing the patient's venous blood and acting as blood volume buffer, is designed for receiving raw cardiotomy suction blood and filtering it to the circulating blood volume. Entrained air is removed from both the venous blood and cardiotomy suction blood by the defoamer.

The nonfiltered version of the COBE® SMAR,T" HVR® 4000" Surface Modified Venous Reservoir is designed for receiving and storage of the patient's venous blood and acting as blood volume buffer during cardiopulmonary bypass. The defoamer removes air entrained in the venous blood.

The major components of the filtered and nonfiltered COBE® SMAR.T™ HVR® 4000* Surface Modified Hardshell Venous Reservoirs are the bucket, the porting, the defoamer, and in the filtered version, the cardiotomy filter. The bucket serves both as a primary structural component of the device and as a transparent vessel to contain excess blood volume and to allow for the monitoring of changes in blood volume. The porting provides blood tubing connections between the reservoir and the patient, the defoamer serves to remove gross air from incoming venous and cardiotomy suction blood, and the filter removes particles from the cardiotomy suction return blood.

The COBE® SMAR.T™ HVR® 4000™ Surface Modified Hardshell Venous Reservoirs are sterile devices with non-pyrogenic fluid pathways, for single use only. They are intended for use during adult cardiac surgical procedures requiring extracorporeal support for periods of up to six hours.

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

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

The document does not specify the exact sample size for the individual performance tests (i.e., defoaming capability, operating volumes, filtration efficiency, blood trauma). Neither is the data provenance explicitly stated (e.g., country of origin, retrospective or prospective). However, it is stated that "In-vitro testing was performed," suggesting that the tests were conducted in a laboratory setting.

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

This information is not provided in the document. The studies describe standard in-vitro performance and biocompatibility tests, which typically rely on established protocols and measurements rather than expert consensus on individual observations in the way diagnostic imaging studies might.

4. Adjudication method for the test set

This information is not provided. Given the nature of the tests (performance and biocompatibility), an adjudication method like 2+1 or 3+1, which is common in human-in-the-loop diagnostic studies, would not be applicable.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a medical device (venous reservoir), not an AI-powered diagnostic tool, so such a study would not be applicable. The performance is assessed through direct physical and biological measurements.

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

This question is not applicable to the COBE® SMAR.T™ HVR® 4000™ Surface Modified Hardshell Venous Reservoir as it is a physical medical device, not an algorithm. The "standalone" performance refers to the device's inherent design and material properties.

7. The type of ground truth used

The ground truth for the performance tests was established by objective physical and biological measurements based on established scientific principles and industry standards for cardiopulmonary bypass equipment. For example, "filtration efficiency" would have a measurable output, and "platelet reduction" would be measured by quantifying platelet counts or adhesion. The "improved blood compatibility" and "non-leaching" of the surface modifying additive were also established through laboratory testing.

8. The sample size for the training set

This information is not applicable. The device is a physical medical device, not a machine learning model, so there is no "training set" in the context of AI.

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

This information is not applicable, as there is no "training set." The device's design and materials were developed and validated based on engineering principles and biomedical science.

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