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The Centrysystem® 3 +plus™ Dialysis Control Unit is indicated for patients in acute or chronic renal failure and when hemodialysis is prescribed by the physician. Both high flux and low flux dialyzers may be used with the Centrysystem® 3 +plus™. The modifications to the Centrysystem® 3 do not significantly affect the intended uses previously claimed for this device. This device is a totally self contained machine that provides the necessary control functions for hemodialysis therapy, including:

• automatically primes the extracorporeal blood circuit (dialyzer and blood tubing set); ●
• . prepares dialysate;
• monitors machine subsystems for proper performance and unsafe conditions; .
• pumps blood, dialysate and anticoagulant at predetermined rates; ●
• controls fluid removal from the patient; and .
• automatically cleans, disinfects and rinses dialysate flow path. .

The Centrysystem Cartridge Blood Tubing Set is intended to be used and an extracorporeal circuit accessory to the Centrysystem® 3 +plus™ Dialysis Control Unit described above.

This device is a totally self contained machine that provides the necessary control functions for hemodialysis therapy, including:

• automatically primes the extracorporeal blood circuit (dialyzer and blood tubing set); ●
• . prepares dialysate;
• monitors machine subsystems for proper performance and unsafe conditions; .
• pumps blood, dialysate and anticoagulant at predetermined rates; ●
• controls fluid removal from the patient; and .
• automatically cleans, disinfects and rinses dialysate flow path. .

The Centrysystem Cartridge Blood Tubing Set is intended to be used and an extracorporeal circuit accessory to the Centrysystem® 3 +plus™ Dialysis Control Unit described above.

I am sorry, but the provided text does not contain the detailed information necessary to complete the request. The documents are a 510(k) clearance letter and an Indications For Use statement for a dialysis control unit. They confirm the device's substantial equivalence to a predicate device and its intended uses, but do not include any acceptance criteria, study details, performance data, sample sizes, expert qualifications, or ground truth information relevant to an AI/ML powered device.

Therefore, I cannot provide the requested table or answer the specific questions about device performance and study methodology based on the input text.

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