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The Vision Blood Cardioplegia is indicated for use in applications that require control of fluid temperature, such as blood or cardioplegia, typically in an extracorporeal circuit. The device may be used for normothermic of hypothermic applications.

The Vision Blood Cardioplegia consists of an extracorporeal heat exchanger and fluid administration set. The heat exchanger consists of a one piece, stainless steel bellows, configured heat exchanger as the primary element to affect heat exchange. This element is encased by a polycarbonate housing, which directs the blood through the outside convolutions of the stainless steel bellows, and therefore effects heat exchange while minimizing priming volume. All materials of the heat exchanger are biocompatible. The device allows for the monitoring of pressure and allows for trapping and removal of air. Additionally, the device includes an integral bubble trap, gross particulate filter (105 m) and pressure relief device designed to open in the event of excessive fluid pressure (600 mmHg) during use. Solutions are delivered to the patient through the extension line and appropriate cannula. Blood flow is driven by a roller pump connected through the extension line.

The provided text describes a 510(k) submission for the "Vision Blood Cardioplegia and Extracorporeal Heat Exchanger" and provides a summary of the device, its indications for use, and a statement about testing. However, it does not include specific acceptance criteria or detailed study results that prove the device meets those criteria.

The document states:
"The Vision Blood Cardioplegia has been subjected to extensive safety, performance, and validations prior to release. Final testing for the systems includes various performance tests designed to ensure that the device meets all of its functional requirements and performance specifications. Safety tests have further been performed to ensure the device complies to applicable industry and safety standards."

And concludes:
"The conclusion drawn from these tests is that the Vision Blood Cardioplegia is equivalent in safety and efficacy to its predicated devices."

This is a general statement that testing was done and a conclusion of equivalence was reached, but it does not provide the specifics requested in your prompt. Therefore, I cannot extract the following information:

1. A table of acceptance criteria and the reported device performance: No specific criteria or performance metrics are listed.
2. Sample size used for the test set and the data provenance: Not mentioned.
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): Not applicable, as this is a medical device, not a diagnostic algorithm requiring expert ground truth in that sense.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable based on the type of device and information 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: Not applicable, as this is a medical device (heat exchanger), not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, this is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for a device like this would typically involve engineering specifications, performance standards, and physiological measurements in animal or simulated models, but these specifics are not provided.
8. The sample size for the training set: Not applicable and not mentioned.
9. How the ground truth for the training set was established: Not applicable and not mentioned.

In summary, the provided text only offers a high-level assertion that testing was conducted and demonstrated equivalence to predicate devices, but lacks the detailed performance criteria and study specifics you requested.

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