Search Results

Hemodialysis with Xenium XPH cialyzers is indicated for patients with acute or chronic renal failure when conservative therapy is judged to be inadequate. Will some of class may be indicated in the treatment of patients intoxicated with poisons or drugs.

Xenium XPH dialyzers are Polyethersulfone fiber dialyzers and will be labeled for single use only. The dialyzers are available in six (6) sizes, which differentiate by membrane surface area.

The provided text is a 510(k) summary for the Xenium XPH dialyzer a medical device. The document states that the device is "substantially equivalent" to a predicate device and that "All test results meet the acceptance criteria". However, it does not provide a table of specific acceptance criteria or detailed device performance results.

Specifically, the document states: "Baxter Healthcare Corporation conducts risk analyses, per ISO 14971, and design verification tests based on the result of these analyses. All test results meet the acceptance criteria, and support that the devices are appropriately designed for their intended use." This is a general statement and does not include the detailed information requested in the prompt.

Therefore, for the requested information, the following can be reported based solely on the provided text:

Acceptance Criteria and Study Details for Xenium XPH Dialyzer

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not specified in the provided text.
• Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective or prospective). The testing appears to be internal "design verification tests" conducted by Baxter Healthcare Corporation.

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

• Number of Experts: Not applicable/Not specified, as the testing described is "design verification tests" rather than clinical studies requiring expert ground truth establishment in the traditional sense.
• Qualifications of Experts: Not applicable/Not specified.

4. Adjudication method for the test set

• Not applicable/Not specified. The document describes "design verification tests," not a study requiring adjudication of interpretations.

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

• No, a MRMC comparative effectiveness study was not done. The device is a dialyzer, not an AI-assisted diagnostic tool for human readers.

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

• Not applicable. The device is a physical dialyzer, not an algorithm.

7. The type of ground truth used

• Not applicable in the context of expert consensus or pathology. The "ground truth" for a dialyzer would relate to its physical and functional performance specifications (e.g., clearance rates, ultrafiltration rates, safety parameters) as measured in design verification tests. The specific "type" is not detailed beyond "design verification tests."

8. The sample size for the training set

• Not applicable. The device is a physical dialyzer, not a machine learning algorithm that requires a training set.

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

• Not applicable.

Ask a specific question about this device