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The OXY-1 System is intended to be used for extracorporeal circulation. The OXY-1 System pumps, oxygenates and removes carbon dioxide from blood during cardiopulmonary bypass up to 6 hours in duration.

The Breethe® OXY-1 System provides extracorporeal circulation for full or partial cardiopulmonary bypass support for up to six hours. The OXY-1 System includes; a disposable pump and oxygenator, a pump driver, blood tubing, and a console for powering and controlling the pump and managing gas flow. These components are designed to operate together to reduce the overall equipment footprint at the bedside.

The provided text is a 510(k) Summary for the Abiomed OXY-1 System, a cardiopulmonary bypass oxygenator. It outlines the device's characteristics, comparison to predicates, and performance data submitted to the FDA for substantial equivalence determination.

However, the document does not contain information related to a study involving acceptance criteria for an AI/ML medical device, human reader performance, ground truth establishment by experts, or MRMC studies. The performance data mentioned (Biocompatibility, Electrical Safety, Software V&V, and Performance Testing per FDA guidance) relates to the physical and functional aspects of the OXY-1 System hardware and software, typical for a Class II medical device of this type, not an AI/ML diagnostic or prognostic system.

Therefore, I cannot extract the information required by your request from the provided text, as the request is geared towards an AI/ML device study, which is not described herein.

To fulfill your request, I would need a document detailing the clinical validation or performance study of an AI/ML medical device.

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