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Hemodialysis with EXELTRA™ dialyzers is indicated for patients with 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.

Model EXELTRA™ 150 and 170 Single Use Dialyzers

This is a 510(k) premarket notification for a medical device, which typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study with acceptance criteria and performance metrics in the way a clinical trial for a novel AI algorithm would.

Based on the provided text, the device is the EXELTRA™ Dialyzer, Single Use (Models 150 and 170). The document states that no clinical data was required or provided for this 510(k) submission because the device is considered "substantially equivalent" to predicate devices and "do not raise any new types of safety and effectiveness issues."

Therefore, many of the requested sections regarding acceptance criteria, study details, sample sizes, expert ground truth, and AI performance metrics are not applicable (N/A) in this context.

Here's an attempt to answer the questions based only on the provided text:

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

No explicit "acceptance criteria" and "reported device performance" in the context of a clinical study are provided because no clinical data was submitted. The acceptance for this 510(k) relies on substantial equivalence to predicate devices and meeting established manufacturing and biological standards.

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. No clinical "test set" data was submitted or required. The "testing" mentioned refers to manufacturing quality control and sterilization validation.

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. No clinical "ground truth" was established with experts for a test set. The validation relies on established international and industry standards for biological evaluation, sterilization, and manufacturing processes.

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

Not applicable. No clinical "test set" requiring adjudication.

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 device is a dialyzer, not an AI-assisted diagnostic or therapeutic tool, and no MRMC study was conducted or referenced.

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

Not applicable. This device is a physical medical device (dialyzer), not an algorithm or software.

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

For biological safety, the "ground truth" is adherence to ISO 10993-1. For sterilization, it's conformance to AAMI/ISO 11137:1994. For manufacturing, it's conformance to "manufacturing specifications." These are regulatory and engineering standards, not clinical ground truth.

8. The sample size for the training set

Not applicable. This device is a physical medical device, not an AI algorithm requiring a training set.

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

Not applicable. This device is a physical medical device, not an AI algorithm requiring a training set.

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