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Optiflux F20NR , F18NR , and F16NR dialyzers are designed for single use acute and chronic hemodialysis.

The Optiflux F20NR , F18NR , and F16NR are e-beam sterilized, low-flux versions of the Optifiux 200NR. The technological characteristics of the Optiflux F20NR®, F18NR°, and F16NR° are equivalent to those of the Optiflux 200NR and Hemoflow F7NR8 and raise no new types of safety or effectiveness questions.

I am sorry, but the provided text does not contain the detailed information necessary to complete the requested table and study description. The document is a 510(k) Premarket Notification Summary of Safety and Effectiveness for hemodialyzers, which primarily focuses on establishing substantial equivalence to predicate devices rather than providing detailed acceptance criteria and performance study results in the format requested.

Specifically, the document does NOT contain:

• A table of acceptance criteria and reported device performance.
• Information on the sample sizes used for test sets or training sets.
• Data provenance (country of origin, retrospective/prospective).
• Number or qualifications of experts used for ground truth.
• Adjudication methods.
• Information on Multi Reader Multi Case (MRMC) comparative effectiveness studies.
• Details on standalone algorithm performance.
• The type or establishment method of ground truth.

The document states that "testing of the Optiflux F20NR , F18NR , and F16NR indicates that they are safe and effective for their intended use," but it does not elaborate on the specific tests, their acceptance criteria, or the detailed results.

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