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

This Special 510(k) describes the following modifications:

• Change in wall thickness of the polysulfone REXEED-SX/LX hollow fibers to 35 um, compared to 45 um for the existing predicate APS/REXEED
• Change in priming procedure to REXEED-SX/LX priming procedure (drytype) from APS/REXEED priming procedure (wet-type)
• Change in sterilization type to electron beam irradiation REXEED-SX/LX Dialyzers, compared to gamma radiation for the existing predicate APS/REXEED
• Change in use to REXEED-SX/LX is available for single use from APS/REXEED which is available for single use and reuse.

This document describes a 510(k) premarket notification for the Asahi REXEED-SX/LX Dialyzers. The focus of the information provided is on demonstrating substantial equivalence to pre-existing predicate devices following certain modifications, rather than a study proving the device meets specific acceptance criteria in a clinical setting with human subjects.

Therefore, many of the requested categories related to clinical study design, ground truth establishment, expert adjudication, and comparative effectiveness with AI assistance are not applicable based on the provided text. The document primarily outlines the engineering and risk management aspects of the device modifications.

Here's an attempt to extract relevant information for the applicable categories:

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

The document states: "All test results meet the acceptance criteria, and proved that those modifications to be appropriate."
However, it does not explicitly list specific acceptance criteria values or detailed performance metrics for the REXEED-SX/LX Dialyzers in a table format within the provided text. It generally refers to "design verification tests based on the result of risk analysis and design input" and that these tests met acceptance criteria.

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

• Sample Size for Test Set: Not specified.
• Data Provenance: The studies are described as "in vitro" ("REXEED SX/LX Dialyzers have been tested in vitro under single use conditions."). The company is based in Japan, so it's likely the tests were conducted there or at facilities contracted by the company. Retrospective or prospective nature is not indicated, but given it's a device modification verification, it would be prospective testing of the modified device.

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)

• Number of Experts: Not applicable. The "ground truth" here relates to engineering and performance specifications validated through testing, not clinical diagnosis.
• Qualifications of Experts: Not applicable.

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

• Adjudication Method: Not applicable. This concept is for clinical assessments, not for engineering verification tests.

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

• MRMC Study: No. This is not an AI/imaging device.

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

• Standalone Performance: Not applicable. This is not an algorithm or AI device.

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

• Type of Ground Truth: The "ground truth" for this device modification review is based on engineering specifications, risk analysis (FMEA), and benchmark performance against the predicate device as demonstrated through "design verification tests." These tests would likely involve measuring physical and functional properties of the dialyzers according to established standards for hemodialysis systems.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. This is not a machine learning or AI device.

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

• How Ground Truth for Training Set was Established: Not applicable.

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