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The AM-R Series Dialyzers are indicated for use in hemodialysis treatment of patients who have chronic renal failure or acute renal failure. Asahi AM-R Dialyzers may be reprocessed for reuse on the same patient.

Asahi AM-R Series Dialyzers cleared under 510(k) K970650 are designed as reusable, hollow fiber (cuprammonium rayon) membranes which are housed within a plastic casing of styrene butadiene block polymer.

The provided text describes a 510(k) submission for the Asahi AM-R Series Dialyzers. It focuses on a modification to the device (update of dialyzer casings) and assesses its substantial equivalence to a predicate device.

Crucially, this document is a 510(k) summary and approval letter, not a study report detailing acceptance criteria and performance data in the manner typically associated with clinical or standalone performance studies for AI/software devices.

Therefore, most of the requested information regarding acceptance criteria, sample sizes, expert involvement, and ground truth establishment cannot be found in this document because it is not a study report designed to evaluate such metrics.

Here's what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance:
   • Cannot be provided. This document does not specify quantitative acceptance criteria or detailed device performance metrics (e.g., sensitivity, specificity, accuracy) like you would find for a diagnostic or AI device. The "performance" assessment is qualitative, stating "Revisions to the casing dimensions... are demonstrated to have an insignificant impact on the performance of the dialyzers."

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

   • Cannot be provided. The document does not describe a "test set" in the context of typical AI/software device evaluation. It refers to a modification of a physical medical device (dialyzer casing) and likely involved engineering tests or bench testing, not a data-driven test set.

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):

   • Cannot be provided. Ground truth, in the context of AI, refers to independently verified labels for data. This document describes a physical device modification, not an AI model requiring annotated data. The assessment of "insignificant impact on performance" would have been made by engineers and regulatory reviewers based on design specifications and potentially bench testing, not expert-labeled test sets.

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

   • Cannot be provided. Not applicable to this type of device modification submission.

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:

   • Cannot be provided. Not applicable. This is not an AI/software device.

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

   • Cannot be provided. Not applicable. This is not an AI/software device.

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

   • Cannot be provided. Not applicable.

8. The sample size for the training set:

   • Cannot be provided. Not applicable. This is not an AI/software device.

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

   • Cannot be provided. Not applicable.

Summary based on the document:

This 510(k) submission is for a physical medical device (dialyzer), specifically a modification to its casing. The core of the submission is to demonstrate that this physical change does not alter the safety or effectiveness of the device compared to its legally marketed predicate.

The "study" referenced is the comparison to the predicate device and the demonstration that the casing revisions have an "insignificant impact on the performance of the dialyzers." This implies a technical assessment (likely engineering and/or bench testing) rather than a clinical trial or AI model validation study.

The acceptance criterion, implicitly, is that the modified device's performance characteristics related to its intended use (hemodialysis) remain substantially equivalent to the predicate device, thereby ensuring no new issues of safety or effectiveness are raised. The document states this outcome was achieved.

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