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Hemodialysis with a PUREFLUXTM-L 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 PUREFLUXTM-L hemodialyzer is a medical device 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 PUREFLUXTM-L hemodialyzer is composed of polyethersulfone fiber and is available in various sizes, which are differentiated by membrane surface area.

The provided document is a 510(k) summary for the Nipro PUREFLUX™-L Hemodialyzer. It details the device's description, intended use, and a comparison to predicate devices, but it does not contain the information requested in points 1-9 regarding specific acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment for a device performance study that would typically be associated with AI or diagnostic imaging devices.

The document discusses non-clinical studies for "analyte clearance (urea, creatinine, phosphate, Vitamin B12), ultrafiltration coefficient and pressure drop" to establish substantial equivalence to predicate devices (K062079 Baxter Xenium Hemodialyzer, K926005 Fresenius Hemoflow, K043244 Fresenius Optiflux). However, it does not provide:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets or data provenance.
• Number/qualifications of experts for ground truth.
• Adjudication methods.
• Results from multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone algorithm performance.
• Type of ground truth used.
• Sample size or ground truth establishment for a training set.

This type of information is generally not relevant for 510(k) submissions of hemodialyzers, which rely on demonstrating substantial equivalence in physical and performance characteristics (like clearance rates and ultrafiltration) to already approved predicate devices, rather than the types of clinical performance evaluations and AI model validation studies relevant to the provided questions.

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