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The LifeMate™ Hemofiltration System is indicated for treatment of renal failure or fluid overload using hemofiltration and/or ultrafiltration. All treatments must be administered by a health care provider, under physician prescription.

The LifeMate™ Hemofiltration System, consisting of hardware, software and a sterile disposable cartridge, is indicated for treatment of renal failure or fluid overload using hemofiltration and/or ultrafiltration. All treatments must be administered by a health care provider, under physician prescription.

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) summary for a Special 510(k) submission, confirming design modifications and substantial equivalence to a predicate device, rather than a clinical study report. It states that "Design Verification testing" was performed to ensure the modified device meets design specifications, but no details on this testing, its results, or specific acceptance criteria are provided.

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