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The Art Hemoadsorption system operates and monitors the extracorporeal blood circuit to perform whole blood or plasma adsorption (when used with a commercially available plasma filter).

In the extracorporeal blood circuit, the blood is continuously anticoagulated with ACD-A solution. The ACD-A flow can be adjusted and is controlled in relation to the blood flow. The ACD-A flow is monitored by a drip counter.

If a whole-blood adsorption treatment is performed, the blood pump transports blood from the inlet side of the patient's vascular access through the adsorber.

If a plasma adsorption treatment is performed, the blood pump transports blood from the inlet side of the patient's vascular access through a plasma filter. The plasma filter separates the plasma from the whole blood. The plasma pump delivers the plasma through the adsorber. The adsorber removes undesired substances from the blood or plasma.

Downstream of the adsorber, the blood or plasma flows into the bubble catcher. In case of plasma adsorption, the plasma is mixed with the blood components that have been separated in the plasma filter beforehand. The blood is then returned to the patient via the return line.

The provided text does not contain any information about acceptance criteria, device performance metrics, or study details (like sample size, ground truth, or expert qualifications).

The document is a 510(k) Premarket Notification for the Fresenius ART Hemoadsorption System. It focuses on demonstrating substantial equivalence to predicate devices (Fresenius 2008K Dialysate Delivery System K994267 and Fresenius AS104 Cell Separator, #K895435), rather than providing a detailed performance study against specific acceptance criteria.

The "Safety Summary" section (page 2, Section F) briefly states: "The Fresenius ART Hemoadsorption System's software validation, functional the I rooonloo ART risting rigorously tested the features of the ART machine. The results of this testing indicate that the ART Hemoadsorption System is safe and effective for its intended use." However, it does not specify what those tests were, what criteria were used for "safe and effective," or the results.

Therefore, I cannot provide the requested table or answer the specific questions about the study that proves the device meets acceptance criteria, as this information is not present in the provided text.

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