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The Prismaflex control unit is intended for: Continuous Renal Replacement Therapy (CRRT) for patients weighing 20 kilograms or more with acute renal failure and/or fluid overload. Therapeutic Plasma Exchange (TPE) therapy for patients weighing 20 kilograms or more with diseases where removal of plasma components is indicated. All treatments administered via the Prismaflex control unit must be prescribed by a physician.

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I am sorry, but the provided text does not contain the information needed to answer your request. The document is a 510(k) premarket notification letter from the FDA regarding the Prismaflex System 7.10, indicating it has been found substantially equivalent to a predicate device. It defines the device, lists its intended uses, and outlines regulatory requirements. However, it does not include any details about acceptance criteria, device performance studies, sample sizes, data provenance, expert ground truth establishment, adjudication methods, multi-reader multi-case studies, standalone algorithm performance, or ground truth types and establishment methods for training sets.

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