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Optiflux Dialyzers are intended for patients with acute kidney disease when conservative therapy is judged to be inadequate.

The Optiflux F180NR dialyzer is a high-flux, single-use, ethylene oxide (EO) sterilized hemodialyzer. The dialyzer is provided blood pathway sterile and non-pyrogenic. The membrane surface area is 1.7 m2.

This document is a 510(k) summary for the Fresenius Medical Care Optiflux F180NR Dialyzer. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the device meets specific acceptance criteria in the manner of an AI/ML medical device.

Therefore, many of the requested points are not applicable to this type of submission.

Here's a breakdown of the available information based on your request:

1. A table of acceptance criteria and the reported device performance

The document does not present a formal table of "acceptance criteria" against "reported device performance" similar to what might be found for a new AI/ML device where specific metrics (e.g., sensitivity, specificity, AUC) are presented against predefined thresholds.

Instead, the document states:

• "All testing met predetermined acceptance criteria. Results of the proposed device design verification tests met the requirements and demonstrated that, like the predicate device, the Optiflux F180NR dialyzer is safe and effective for its intended use." (Page 6)

The "key performance characteristic" explicitly mentioned is Urea clearance, with Sodium clearance being used as a marker.

Note: The document states that performance testing was conducted in accordance with ISO 8637:2010 and FDA Guidance for the Content of Premarket Notifications for Conventional and High Permeability Hemodialyzers, August 1998. The specific numerical acceptance criteria for each test are not provided in this summary.

2. Sample size used for the test set and the data provenance

The document provides a summary of tests performed, but does not specify the sample sizes (number of devices, or specific data points) used for each test. It also does not mention data provenance (e.g., country of origin, retrospective/prospective) for these engineering and performance tests, as these are typically bench-top or in vitro tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This device is a physical hemodialyzer, not an AI/ML device that relies on expert interpretation for ground truth. The "ground truth" for its performance is established through standardized engineering and in vitro testing methods.

4. Adjudication method for the test set

Not applicable. Adjudication methods like 2+1 or 3+1 are used for human expert ground truth establishment for AI/ML devices. For this physical device, performance is evaluated against engineering specifications and standards.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a physical medical device (dialyzer), not an AI/ML software. Therefore, MRMC studies and AI assistance for human readers are irrelevant.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

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

7. The type of ground truth used

The "ground truth" for the device's performance is established through standardized in vitro bench testing following recognized international standards (ISO 8637:2010) and FDA guidance documents. This includes:

• Calculated measurements (e.g., blood compartment volume, ultrafiltration, pressure drop).
• Analytical testing of samples (e.g., clearance of various substances, protein sieving coefficient).
• Physical integrity tests (e.g., structural and blood compartment integrity).
• Biocompatibility tests (e.g., cytotoxicity, sensitization, hemolysis).
• Simulated shipping and distribution tests.

8. The 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. As above, there is no "training set" for a physical dialyzer.

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