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Diacap LO PS (10, 12, 15) and Diacap HI PS (10, 12, 15, 18, 20) Hemodialyzers are designed for single use in acute and chronic hemodialysis.

The Diacap LO PS (10, 12 and 15) and Diacap HI PS (10, 12, 15, 18 and 20) are, respectively, conventional permeability and high permeability hemodialyzers. The hollow, polysulfone membrane is housed within a plastic cylinder with four ports: two ports for blood compartment access and two ports for dialysate access.

The provided text is a 510(k) summary for the B. Braun Medizintechnologie G.m.b.H. Diacap LO PS and HI PS Hemodialyzers. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not include detailed acceptance criteria or a study that specifically addresses device performance against stated acceptance criteria in the way typically expected for an AI/ML device where performance metrics (e.g., sensitivity, specificity, AUC) are calculated.

This document describes a medical device (hemodialyzers), not an AI/ML system. Therefore, the questions related to AI/ML device performance metrics, sample sizes for test/training sets, expert adjudication, MRMC studies, and ground truth establishment in that context are not applicable.

Instead, the performance evaluation for these hemodialyzers focused on bench and clinical testing to demonstrate performance and safety, primarily in comparison to a predicate device.

Here's how to interpret the available information:

1. Table of acceptance criteria and the reported device performance:

The document doesn't explicitly state "acceptance criteria" in a quantitative table with thresholds. Instead, it states that the device's performance was evaluated against "expected values" and through "comparison with the predicate device".

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: Not specified. The document mentions "clinical testing" but does not detail the number of subjects or samples.
• Data provenance: Not specified.

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

This information is not applicable and not provided. Performance evaluation for hemodialyzers does not typically involve "experts establishing ground truth" in the way an AI/ML diagnostic device would. Performance is assessed through direct measurement of physical and physiological parameters.

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

Not applicable and not provided.

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 not an AI/ML device.

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

Not applicable. This is not an AI/ML device.

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

The "ground truth," in the context of a hemodialyzer, would be the direct measurement of its physical properties (e.g., surface area, membrane characteristics) and its performance in clearing solutes and removing fluid in bench and clinical settings, as well as the physiological response of patients (e.g., blood cell counts, inflammatory markers). It's based on direct measurement and observed physiological effects rather than expert consensus on diagnostic images or pathology.

8. The sample size for the training set:

Not applicable. This is not an AI/ML device and thus does not have a "training set" in that sense.

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

Not applicable. This is not an AI/ML device.

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