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Hemodialysis with EXELTRA™ Plus 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.

Models EXELTRA™ Plus 210 Single Use Dialyzer

The provided document is a 510(k) summary for the EXELTRA™ Plus Dialyzer, a medical device for hemodialysis. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than providing extensive clinical study data for acceptance criteria based on performance metrics.

Therefore, much of the requested information regarding acceptance criteria and detailed study designs for a device's performance against those criteria is not present in this document. This is typical for 510(k) submissions, especially for devices where the underlying technology is well-established and the new device is a modification or equivalent to an existing cleared device.

Specifically, the document states: "Clinical Data: N/A"

However, I can extract the information that is available:

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

The document does not provide a table of quantitative acceptance criteria for device performance (e.g., clearance rates, ultrafiltration rates) nor corresponding performance data from a specific study designed to meet these criteria. Instead, it relies on demonstrating equivalence to predicate devices and adherence to relevant standards.

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

This information is not provided. The submission states "Clinical Data: N/A," indicating no human clinical trials were conducted specifically for this 510(k) submission to demonstrate performance in a test set. The functional testing mentioned is likely internal quality control or engineering testing, not a formal clinical test set with patient data.

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)

This information is not applicable/not provided. As "Clinical Data: N/A," there was no clinical test set for which ground truth would be established by external experts.

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

This information is not applicable/not provided. No clinical test set.

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

This information is not applicable/not provided. The device is a medical device (dialyzer), not an AI diagnostic or assistance tool. Therefore, MRMC effectiveness studies with human readers and AI are not relevant.

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

This information is not applicable/not provided. The device is a dialyzer, not an algorithm.

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

For the biological and sterilization testing, the "ground truth" would be established by the standards themselves (ISO 10993-1, AAMI/ISO 11137:1994) through accredited laboratory testing following those standards. For manufacturing specifications, the ground truth is the defined engineering specifications of the product. No clinical ground truth (e.g., pathology, outcomes data) from a new study is referenced.

8. The sample size for the training set

This information is not applicable/not provided. There is no "training set" in the context of this device and submission type (no AI or machine learning model involved).

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

This information is not applicable/not provided. No training set.

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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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