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Hemodialysis with a PUREFLUX-H 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 PUREFLUX-H 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 PUREFLUX-H dialyzers are composed of polyethersulfone fiber and are available in six sizes, which differentiate by membrane surface area.

The provided text is a 510(k) summary for the Nipro PUREFLUX™-H Hemodialyzer, describing its substantial equivalence to a predicate device, rather than a study detailing acceptance criteria and performance against those criteria in the context of an AI/ML device. Therefore, much of the requested information regarding AI/ML study design, such as sample sizes for test and training sets, expert consensus, adjudication methods, and MRMC studies, is not applicable to this document.

However, I can extract the information relevant to the device and its testing as described in the provided text.

Here's the closest analog to the requested table and study information based on the provided hemodialyzer documentation:

Acceptance Criteria and Device Performance for Nipro PUREFLUX™-H Hemodialyzer

The Nipro PUREFLUX™-H Hemodialyzer's acceptance criteria and performance were established through non-clinical studies demonstrating substantial equivalence to a predicate device (K062079 Baxter Xenium Hemodialyzer). The primary acceptance criterion was that the PUREFLUX-H dialyzer performs as well as the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

• Urea
• Creatinine
• Phosphate
• Vitamin B12
• Myoglobin |
  | Ultrafiltration Coefficient | Comparable ultrafiltration coefficient to predicate. | Results demonstrate substantial equivalence. |
  | Pressure Drop | Comparable pressure drop characteristics to predicate. | Results demonstrate substantial equivalence. |

2. Sample Size for Test Set and Data Provenance

• Sample Size for Test Set: Not explicitly stated in the provided document. The studies were non-clinical, likely involving in vitro testing of multiple units of each of the six available sizes of the PUREFLUX-H dialyzer.
• Data Provenance: The studies were non-clinical, meaning they were conducted in a laboratory setting, not with human or animal subjects. The country of origin of the data is not specified beyond the submitter being Nipro Medical Corporation in Miami, FL, USA. The data is prospective in the sense that it was generated for the purpose of demonstrating equivalence, but it is not clinical data.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. For this type of medical device (hemodialyzer), ground truth is established through validated physical and chemical testing methods, not by expert consensus on interpretations of images or other data typically found in AI/ML studies. Performance metrics like analyte clearance, ultrafiltration coefficient, and pressure drop are measured directly.

4. Adjudication Method for the Test Set

Not applicable. As described above, the "ground truth" is based on direct measurements from non-clinical tests, not expert interpretation requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This device is a physical hemodialyzer, not an AI/ML diagnostic tool or an assist device for human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant.

6. Standalone (Algorithm Only) Performance Study

Not applicable. This device is a physical medical device, not an algorithm.

7. Type of Ground Truth Used

The ground truth used was based on direct measurements from non-clinical (laboratory) studies that quantify the physical and chemical performance characteristics of the hemodialyzer. This includes measurements of analyte clearance (urea, creatinine, phosphate, Vitamin B12, myoglobin), ultrafiltration coefficient, and pressure drop. The "ground truth" for equivalence was the performance of the legally marketed predicate device (K062079 Baxter Xenium Hemodialyzer).

8. Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. No training set was used.

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