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Optiflux Dialyzers are intended for patients with acute or chronic renal failure 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. They Optiflux dialyzers are available in four (4) sizes. The sizes are differentiated by membrane surface area.

Medical Device: Optiflux Dialyzers F160NR, F180NR, F200NR, and F250NR

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states "Performance testing was conducted in accordance with ISO 8637:2010. Results of the testing listed below support the determination of substantial equivalence." This implies that the acceptance criteria for these tests are the standards outlined in ISO 8637:2010 and the results met those standards, demonstrating equivalence to the predicate.

2. Sample Size Used for the Test Set and Data Provenance

   • The document does not specify the sample sizes used for each specific test (e.g., clearance testing, structural integrity, biocompatibility).
   • The data provenance is from in vitro testing. The country of origin of the data is not specified, but the manufacturer is Fresenius Medical Care North America (Waltham, MA, USA). The study is retrospective in the sense that it relies on bench testing as opposed to prospective clinical trials.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

   • This information is not provided in the document. The tests performed are primarily bench-top (in vitro) and adherence to recognized standards (ISO 8637:2010) and biocompatibility principles. Ground truth in this context is typically established by laboratory testing protocols and established scientific methods, rather than expert interpretation of results.

4. Adjudication Method for the Test Set

   • An adjudication method similar to 2+1 or 3+1 is not applicable for the reported performance tests. These are objective laboratory measurements against defined standards or comparisons.

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

   • No, an MRMC comparative effectiveness study was not performed.
   • This type of study is not relevant for this device, which performs a physical function (blood filtration) rather than requiring human interpretation of diagnostic images or data.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

   • Yes, the performance reported is a standalone performance of the device. The device functions mechanically/chemically based on its design and materials. There is no human interaction during the "performance" measurement itself.

7. Type of Ground Truth Used

   • The ground truth used for performance evaluation is based on objective laboratory measurements as defined by recognized standards (e.g., ISO 8637:2010) and established scientific principles for measuring physical parameters (clearance, ultrafiltration, structural integrity) and biological compatibility. It is not based on expert consensus, pathology, or outcomes data in the usual sense for diagnostic devices.

8. Sample Size for the Training Set

   • This information is not applicable as the device is not an AI/ML algorithm that requires a training set. The "training" for such a device is its design, manufacturing processes, and adherence to engineering specifications.

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

   • This information is not applicable for the same reasons as above.

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