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The Prismaflex control unit is intended for:
· Continuous Renal Replacement Therapy (CRT) 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.

The Prismaflex control unit is a software controlled device that performs the following functions:
Loads and primes the Prismaflex disposable set automatically.
• Pumps blood through the blood flow path of the Prismaflex disposable set.
· Delivers anticoagulant solution into the blood flow path.
• Pumps sterile infusion solutions into the blood flow path of the Prismaflex disposable set according to therapy in use.
· Pumps sterile dialysate into the fluid compartment of the filter in CRRT therapies.
· Controls the patient fluid removal or plasma loss according to the therapy in use.
• Monitors the system and alerts the operator to abnormal situations through alarms.
· Provides treatment data to an external Patient Data Management Systems (PDMS)

The provided document, a 510(k) premarket notification letter from the FDA to Baxter Healthcare Corporation for the Prismaflex System 8.10, is a regulatory submission for a medical device. It does not contain information about an AI/ML-based medical device software or a study that proves a device meets acceptance criteria in the context of an AI/ML system's performance metrics (like sensitivity, specificity, or AUC).

The document details the device's substantial equivalence to a predicate device (Prismaflex System 7.10) based on its functional parameters, physical characteristics, and adherence to performance standards for a hemodialysis system. The "acceptance criteria" here refer to the predefined performance ranges and characteristics of the device itself (e.g., dialysate flow rate accuracy, blood flow rate accuracy, pressure sensor accuracy), and the "study" is the non-clinical testing (software and system verification and validation) done to prove that the updated Prismaflex System 8.10 meets these established parameters and functions equivalently to its predecessor.

Therefore, I cannot extract the requested information, which pertains to AI/ML device performance and testing, from this document. The document primarily focuses on demonstrating substantial equivalence for a non-AI/ML medical device based on established performance specifications and regulatory compliance.

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