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Hemodialysis with Xenium dialyzers is indicated for patients with acute or chronic renal failure when conservative therapy is judged to be inadequate. It also may be indicated in the treatment of patients intoxicated with poisons or drugs.

Xenium dialyzers are polyethersulfone fiber dialyzers and will be labeled for single use only. The dialyzers are available in six sizes, which differentiate by membrane surface area. The polyethersulfone hollow fiber membrane is the same as that contained in NxStage System One cleared under NxStage Medical's premarket notification K050525. All other components in Xenium are the same as those contained in the Exeltra dialyzer cleared under Baxter's premarket notification K030974.

Here's an analysis of the provided text regarding the Xenium Dialyzer, focusing on the acceptance criteria and the study performed:

This document is a 510(k) premarket notification for a medical device (Xenium Dialyzer), and as such, it primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed clinical study with acceptance criteria and device performance metrics in the way a clinical trial report would.

Therefore, many of the requested sections (e.g., sample size for test set, number of experts, adjudication methods, MRMC study, training set details) are explicitly listed as "Not Applicable" or are not present in this type of submission.

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

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 Applicable. This submission relies on demonstrating substantial equivalence through design, materials, and in vitro performance testing according to standards. A separate "test set" in the context of clinical data for performance metrics is not detailed in this submission summary as the device is not expected to produce new safety and effectiveness issues.
• Data Provenance: The in vitro performance testing mentioned follows EN 1283, an international standard. No specific country of origin for in vitro test data is stated, nor is it categorized as retrospective or prospective in this summary.

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. This type of regulatory submission for a dialyzer does not typically involve human expert interpretation of a clinical test set to establish ground truth in the way, for example, a diagnostic imaging AI would. The "ground truth" here is the established safety and performance of the predicate devices and the compliance with engineering standards.

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

• Not Applicable. See point 3.

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-based diagnostic tool that assists human readers.

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

• Not Applicable. This is a physical medical device. The "performance" assessment is of the device's physical and functional characteristics (e.g., membrane integrity, clearance rates, etc.) as per EN 1283, not an algorithm's output.

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

• The "ground truth" in this context is the established safety and performance of the predicate devices. For the new device, the "ground truth" for demonstrating equivalence relies on:
  • Material Equivalence: The use of the same polyethersulfone membrane as one predicate and the same other components as another predicate.
  • Performance Standard Compliance: Adherence to EN 1283 standards for dialyzer performance.
  • Intended Use Equivalence: The intended use of the Xenium dialyzer is identical to the predicate devices.

8. The sample size for the training set

• Not Applicable. There is no AI algorithm being trained in this context.

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

• Not Applicable. There is no AI algorithm and therefore no training set.

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