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FX CorAL dialyzers are intended for hemodialysis (HD), hemodiafiltration (HDF), hemofiltration (HF), and isolated ultrafiltration in patients with acute kidney injury or chronic kidney disease when conservative therapy is judged to be inadequate.

The FX CorAL dialyzers are high-flux, single-use, steam-sterilized hemodialyzers. The dialyzers are provided blood pathway sterile and non-pyrogenic. The dialyzers allow for the transfer of water and solutes between blood and dialysate using semipermeable, hollow fiber membranes.

The provided text describes a 510(k) premarket notification for Fresenius Medical Care's FX CorAL dialyzers. It outlines the device, its intended use, and the performance data submitted to demonstrate substantial equivalence to legally marketed predicate devices.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Key Takeaway: The provided document is a 510(k) summary for a medical device (dialyzers), which focuses on demonstrating "substantial equivalence" to existing cleared devices rather than providing a detailed clinical trial report with specific acceptance criteria tables and detailed performance data like an AI/ML device would. The performance criteria are primarily related to the physical and functional aspects of the dialyzer and its ability to clear solutes.

1. Table of Acceptance Criteria and Reported Device Performance:

The document summarizes performance testing but does not present a formal table of "acceptance criteria" alongside specific numerical "reported device performance" for each criterion. Instead, it states:

"All testing met predetermined acceptance criteria and demonstrated that, like the predicate devices, the FX CorAL dialyzers are safe and effective for their intended use."

However, it does list Key Performance Specifications/Characteristics as Urea clearance. It then provides a table of "Typical Urea Clearance (mL/min)" for different FX CorAL dialyzers:

Other performance tests are listed under "Performance Data" (Table 3), but without numerical acceptance criteria or results. These include:

• Blood Compartment Volume: "Results were compared with the acceptance criteria."
• Clearance: For Sodium (marker for urea), Creatinine, Phosphate, Vitamin B12, β2-Microglobulin. "Calculated by analyzing test samples over the specified range of blood, dialysate, and filtration flow rates."
• Protein Sieving Coefficient: "Calculated in accordance with ISO 8637-1 First Edition 2017-11."
• Ultrafiltration (Blood Kuf): "Calculated as the slope from a plot of the measured ultrafiltration rate (UFR) over the applied transmembrane pressure (TMP) range versus the applied TMP."
• Pressure Drop: Both blood and dialysate compartments.
• Structural Integrity (Dialyzer Integrity): Positive and negative pressure decay measured.
• Blood Compartment Integrity (Membrane Integrity): Observed for air bubbles.
• Simulated Shipping and Distribution: Performance testing after simulation to demonstrate product and package integrity and sterility are maintained.

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

• Manufacturing/In-vitro Performance Testing (Test Set): The document does not specify the exact sample sizes (N number of dialyzers) used for the various in-vitro performance tests (e.g., urea clearance, pressure drop, integrity). It generally refers to "test samples."
• Clinical Studies: Three (3) "outside the U.S. (OUS) clinical trials" were conducted. The document does not specify the sample size for these trials.
• Data Provenance: The in-vitro performance data is generated from laboratory testing of the device itself (dialyzers). The clinical trial data is from "outside the U.S. (OUS) clinical trials." The data provenance is described as including "post-market surveillance." The clinical trials would be prospective studies, evaluating safety and performance.

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

• For Manufacturing/In-vitro Test Set: No external experts are mentioned for establishing ground truth. The ground truth for these tests is based on established engineering principles, ISO standards (e.g., ISO 8637-1), and internal quality control measurements as described in the "Test Method Description" column of Table 3.
• For Clinical Trials: The document states that clinical trials "evaluated safety and performance" and found "comparable safety to the reference dialyzers without new safety signals." While healthcare professionals (physicians, nurses) were involved in these trials, the document does not specify the number or qualifications of "experts" used to establish ground truth in the sense of an independent review, as would be typical for image-based AI/ML devices. The "ground truth" here would be clinical outcomes, safety endpoints, and performance metrics observed in patients.

4. Adjudication Method for the Test Set:

• For Manufacturing/In-vitro Test Set: No adjudication method is mentioned or applicable in the context of physical product testing. Performance is measured against predefined specifications.
• For Clinical Trials: Adjudication methods are not described. Clinical trials typically have predefined endpoints and statistical analysis plans, but the specific process for adjudicating ambiguous clinical events (e.g., by an independent committee) is not detailed in this summary.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:

• Not applicable: This device is a physical medical device (dialyzer) and not an AI/ML algorithm for diagnostic imaging. Therefore, no MRMC study was performed, nor is an effect size for human readers improving with AI assistance relevant.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

• Not applicable: This is a physical device, not an algorithm. The performance data presented (e.g., urea clearance) is the "standalone" performance of the dialyzer itself, not an algorithm.

7. The Type of Ground Truth Used:

• For Manufacturing/In-vitro Performance Testing:
  • Validated Measurement Standards: Ground truth is based on physical and chemical measurements (e.g., sodium and urea concentration, flow rates, pressure) according to established international standards (ISO 8637-1) and internal test procedures.
  • Benchmarking against Predicate Devices: Performance is also evaluated in comparison to predicate devices, implying that acceptable performance is considered to be comparable to these legally marketed devices.
• For Clinical Trials:
  • Clinical Outcomes/Safety Endpoints: "Safety and performance" were evaluated, and the incidence of hypersensitivity and hypersensitivity-like reactions was monitored. This indicates that patient outcomes and adverse events served as the clinical ground truth.

8. The Sample Size for the Training Set:

• Not applicable: This document describes a physical medical device, not an AI/ML algorithm that requires a "training set." The dialyzers are manufactured according to a design, and performance is tested based on that design.

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

• Not applicable: As there is no AI/ML training set, there is no corresponding ground truth establishment for it.

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