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The AngioVac Circuit is indicated for use in procedures requiring extracorporeal circulatory support for periods of up to six hours.

The AngioVac Circuit is an extracorporeal perfusion set that includes four subassemblies including a main perfusion circuit (manufactured of 0.375" non-DEHP PVC coextruded tubing with Y-connector, tubing quick-connects and priming line), waste line, tuohy adapter and reinfusion cannula connector. An extra reinfusion cannula connector and tuohy adapter are provided in a sealed pouch with the circuit.

The provided text is a 510(k) summary for the AngioVac Circuit, a medical device. It describes design modifications to an existing device, and its intended use, but it does not contain information about a study that assesses the performance of an AI/ML device against specific acceptance criteria.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, as the document pertains to a medical device where performance is evaluated through bench testing and biocompatibility rather than AI/ML model performance.

Specifically, the document states:

• "G. Performance Data: Bench testing, including physical integrity and performance testing, was performed to support substantial equivalence of the AngioVac Circuit. The AngioVac Circuit met all specified design and performance requirements."
• "H. Clinical Testing: Not applicable"

This confirms that the evaluation performed for this device was based on bench testing (physical and performance characteristics) and biocompatibility, not on a study measuring the diagnostic or predictive performance of an AI/ML algorithm against a test set with established ground truth.

If you have a different document related to an AI/ML medical device, please provide it, and I will be happy to assist with your request.

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