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Hemodialysis with an ELISIO™-H or an ELISIO™-M hemodialyzer is indicated for patients with acute or chronic renal failure when conservative therapy is judged to be inadequate. It also may be indicated in the treatment of patients intoxicated with poisons or drugs.

The device is for prescription use only. This product is intended for single use only. The performance properties of reused dialyzers have not been established.

The ELISIO-H and ELISIO-M hemodialyzers are medical devices used as an artificial kidney system for the treatment of patients with renal failure. During treatment, blood is circulated from the patient through the hemodialyzer's blood compartment, while the dialysate solution flows countercurrent through the dialysate compartment. In this process, toxins and/or fluid are transferred across the membrane from the blood to the dialysate compartment.

The ELISIO-H and ELISIO-M dialyzers are composed of polyethersulfone fiber and are available in various sizes, which are differentiated by membrane surface area.

The provided text describes a 510(k) summary for Nipro ELISIO™-H and ELISIO™-M Hemodialyzers, which are medical devices used for hemodialysis in patients with renal failure.

Based on the provided text, there is no information related to acceptance criteria, device performance tables, sample sizes, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone algorithm performance, or training set details.

The document is a regulatory submission (510(k) summary) and primarily focuses on:

• Device Identification: Trade names, classification, common name.
• Device Description: What the device is, how it works, and its components (polyethersulfone fiber membrane, polypropylene casing).
• Intended Use: Conditions for which the device is indicated (acute or chronic renal failure, drug/poison intoxication).
• Technological Aspects and Substantial Equivalence: Comparison to predicate devices, noting the membrane composition is identical and the modification is a change in casing material from polycarbonate to polypropylene. It mentions non-clinical studies for biocompatibility demonstrating substantial equivalence.
• Conclusion: States that testing indicates the ELISIO™-H and ELISIO™-M dialyzers are safe, effective, and perform as well as predicate devices.
• FDA Communication: Formal letter from the FDA granting substantial equivalence.

Therefore, I cannot provide the requested information regarding acceptance criteria, study details, or ground truth establishment as it is not present in the provided text. The document focuses on regulatory approval based on demonstrating equivalence to an existing predicate device, primarily through material changes and biocompatibility testing, rather than detailed performance metrics against specific acceptance criteria.

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