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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 Abiomed OXY-1 System provides extracorporeal circulation for cardiopulmonary bypass support for up to six hours in duration. The OXY-1 System includes:

• A Disposable pump and oxygenator .
• A Pump Driver (blood pump) ●
• Blood tubing .
• A Console for controlling the pump and managing gas flow .
  These components are designed to operate together, simplify operation, and 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 is not a document describing an AI/ML-driven medical device, nor does it contain information about acceptance criteria or studies related to AI/ML device performance.

Therefore, I cannot extract the requested information regarding acceptance criteria and the study proving the device meets them, specifically in the context of an AI/ML device, as the provided document pertains to a traditional medical device (a cardiopulmonary bypass oxygenator).

The information requested in your prompt (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance, training set details) are all relevant to the validation of AI/ML models. Since this document describes a physical medical device, these concepts are not applicable.

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