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A. REXEED-SX/LX Dialyzers is intended for use for hemodialysis treatment of patients who have chronic or acute renal failure.
B. REXEED SX/LX Dialyzers must be used in accordance with the instructions for a physician familiar with hemodialysis and familiar with the conditions of the patient.
C. REXEED SX/LX Dialyzers have been tested in vitro under single use conditions.

The line of Asahi REXEED-SX/LX Series Dialyzer is a family of high permeability hollow fiber dialyzers intended for the treatment of patients with acute or chronic renal failure. REXEED-SX/LX Series Dialyzer is designed for single use. REXEED-SX/LX Series Dialyzer is constructed of hollow fiber (polysulfone) membranes, housed within a plastic casing of styrene-butadiene block copolymer and are subjected to electron beam irradiation prior to shipment.

The provided 510(k) summary for the Asahi REXEED-SX/LX Series Dialyzer describes modifications to an already cleared device and focuses on proving that these modifications do not compromise the device's safety and effectiveness compared to the predicate device. It is not a study establishing initial device performance against specific clinical acceptance criteria.

Therefore, the requested information elements related to a study proving the device meets acceptance criteria, such as a table of performance, sample sizes for test sets, expert ground truth, adjudication methods, MRMC studies, or standalone performance, are not applicable or available in this document. The submission is a "Special 510(k)," which typically focuses on demonstrating that modifications do not raise new questions of safety or effectiveness.

Here's an analysis of the available information:

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

• Not Applicable/Not Provided. This submission is for modifications to an already cleared device. The document states, "All test results meet the acceptance criteria, and proved that those modifications to be appropriate," but it does not specify what those acceptance criteria were or present a table of results against them. The focus is on demonstrating that the modifications do not negatively impact performance, rather than establishing initial performance metrics.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

• Not Applicable/Not Provided. The document refers to "design validation or where appropriate, design verification, and process validation" studies. However, it does not specify the sample sizes or provenance of data used in these studies. These are typically internal engineering tests rather than clinical studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

• Not Applicable/Not Provided. There is no mention of expert-established ground truth for a test set, as this is not a diagnostic device involving human interpretation.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• Not Applicable/Not Provided. Not relevant for the type of device and submission.

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 hemodialysis dialyzer, not a diagnostic device involving human readers or AI assistance.

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

• Not Applicable. This is a hardware medical device; it does not involve algorithms or AI.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

• Not Applicable/Not Provided. The "ground truth" for a hemodialysis dialyzer would generally relate to its physical properties, manufacturing quality, and in-vitro performance (e.g., blood compatibility, filtration rates, structural integrity, absence of leakage). The document states, "REXEED SX/LX Dialyzers have been tested in vitro under single use conditions," indicating in vitro performance data would be the primary "ground truth" equivalent.

8. The sample size for the training set:

• Not Applicable. This is not a machine learning or AI device that requires a training set.

9. How the ground truth for the training set was established:

• Not Applicable. Not a machine learning or AI device.

Summary of what is provided:

• Acceptance Criteria Mention: The document states that "All test results meet the acceptance criteria, and proved that those modifications to be appropriate." However, the specific acceptance criteria themselves are not detailed in this public summary. They would be part of the full submission, likely related to manufacturing quality, physical properties (e.g., leakage, hollow fiber specifications), and in vitro performance (e.g., clearance rates, ultrafiltration rates, biocompatibility).
• The Study/Evaluation: The "study" is referred to as "Asahi's device evaluation studies and overall process for managing medical device risk," which includes a risk analysis (FMEA) and "Design validation or where appropriate, design verification, and process validation." These studies were performed to verify the impact of the described modifications (manufacturing process change, labeling change, and device modification related to leakage and physical properties).
• Purpose of the Study: To establish that the modified Asahi REXEED-SX/LX Series Dialyzer is substantially equivalent in intended use/indications for use, design, principle of operation, technology, materials, specifications, and performance to the predicate REXEED-SX/LX Series Dialyzer. The predicate devices were previously cleared under K001250, K041726, K051187, and K082515.

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