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Optiflux dialyzers are intended for hemodialysis, hemodiafiltration, hemofiltration, and isolated ultrafiltration in patients with acute kidney injury or chronic kidney disease when conservative therapy is judged to be inadequate.

The Optiflux dialyzers are part of the FMCRTG family of single use dialyzers which allow for the transfer of water and solutes between blood and the dialysate through a semi-permeable membrane. The Optiflux dialyzers are available in three (3) sizes. The sizes are differentiated by housing size, fiber count per bundle, and effective membrane surface area.

Optiflux dialyzers are high-flux, sterile devices designed for single use hemodialysis and hemodiafiltration for the treatment of acute kidney injury or chronic kidney disease. The dialyzer is configured to connect to a bloodline set which connects to a patient's vascular access system when used with a dialysis machine equipped with ultrafiltration control. During treatment, blood is pumped from the patient's body through an extracorporeal circuit, one component of which is the dialyzer contains a semi-permeable membrane that allows for diffusion and/or convection to transport toxins and excess fluid from the blood compartment (fiber lumen) to the dialysate or filtrate compartment. Dialyzers utilize a counter-current flow in which dialysate and blood flow in opposite directions in the dialyzer during hemodialysis. The counter-current flow maintains the concentration gradient across the membrane for waste and fluid removal.

The provided text does not contain information about an AI/algorithm-based device. The device described, Optiflux® Series of Dialyzers, is a medical device for hemodialysis, hemodiafiltration, hemofiltration, and isolated ultrafiltration. Therefore, this document cannot fulfill the request to provide details about acceptance criteria and study proving device meets acceptance criteria for an AI/algorithm-based device.

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