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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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Asahi AM-R Series Dialyzers are intended for use for hemodialysis treatment of patients who have chronic renal failure or acute renal failure.

Asahi AM-R Series Dialyzers have been tested in vitro and in confirmatory clinical studies under reprocessing and reuse conditions for up to 15 reuse cycles. Based on the results from these evaluations, Asahi AM-R Series Dialyzers may be reprocessed for reuse on the same patient. If reprocessing and reuse is practiced, it is recommended that the reuse be done under the conditions as existed in the in vitro and confirmatory clinical studies as recommended immediately below. It is noted that the Asahi AM-R Series Dialyzers have not been tested for reuse when reprocessed with agents and/or processes other than these, and the performance of the dialyzers under other conditions are not known and cannot be recommended.. Accordingly:

• (1) The reprocessed dialyzer may be used only if the residual Total Cell Volume (TCV) is at least 80% of the original TCV and if such dialyzer otherwise meets the acceptance criteria of the instructions for use and the instructions of the reprocessing system utilized. Furthermore, the policies, instructions and criteria of the institution for reuse (e.g., concerning dialyzer performance, residual blood, and/or dialyzer leakage or damage) should be followed.
• (2) The reprocessing agent may be either (1) 4% formaldehyde (also known as formalin ) in conjunction with the Seratronics Reprocessing Systems for Dialyzer Reprocessing and Preparation (DRS4TM and DPS4TM), manufactured by Seratronics, Inc., or (2) Renalin® in conjunction with the Renatron® Dialyzer Reprocessing System, manufactured by Renal Systems, Inc.
• The instructions provided by the manufacturer of the chosen reprocessing (3) agent must be followed in reprocessing the dialyzer.
• The reprocessed dialyzer may be used only on dialysis systems equipped with (4) volumetric ultrafiltration controllers.

The AM-R Series Dialyzers are a family of hemodialyzers developed to provide safe and effective hemodialysis over ranges of dialyzer patient treatment requirements. The performance of these dialyzers, when new for single or initial (first) use and when reprocessed for reuse, have been documented through laboratory (in vitro) testing and confirmatory clinical testing. Assahi AM-R Series Dialyzers are constructed of hollow fiber membranes of cuprammonium rayon housed within a plastic casing of styrene butadiene block polymer. Asahi AM-R Series Dialyzers are sterilized before shipment by gamma radiation (y-rays). The dialyzer is no longer sterile after its sterile package is opened for the initial (first) use.

This document describes the Asahi AM-R Series Dialyzers and their approval for reuse after reprocessing. The acceptance criteria and supporting studies are detailed below.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Non-clinical (In Vitro) Testing:
  • Biocompatibility: The largest model (AM-R-90U) was subjected to 15 reprocessing cycles.
  • Performance (Kuf, Urea, Creatinine, Vitamin B12 clearances): The smallest model (AM-R-50M) and the largest model (AM-R-90U) were tested in vitro for initial use and up to 15 reuse cycles. Outdated human blood from a blood bank was used.
• Clinical Testing:
  • The largest model (AM-R-90U) was tested in confirmatory clinical studies for initial use and up to 15 reuse cycles.
  • Sample Size: Minimum of 12 patients enrolled at each of two clinical sites. A minimum of 50% of these patients reused the dialyzer 15 times.
  • Data Provenance: The study was a prospective clinical study conducted at two clinical sites that utilized both formalin and Renalin® reprocessing agents. The country of origin of the data is not explicitly stated, but it refers to typical US dialysis practices and FDA guidance, suggesting a US context.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

The document does not explicitly state the number of experts used to establish ground truth or their specific qualifications for the clinical studies. However, it mentions that "dialysis sessions were conducted and patients were managed in accordance with established dialysis practices for the respective institutions," implying that qualified medical professionals (e.g., nephrologists, dialysis nurses) were involved in managing patient care and assessing outcomes.

4. Adjudication Method for the Test Set

The document does not explicitly detail an adjudication method (e.g., 2+1, 3+1) for the test set. Clinical outcomes were assessed by comparing reprocessed device performance against initial use performance within each patient, following established clinical protocols at the participating institutions.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done. The study focuses on the device's performance with and without reuse, not on the improvement of human readers with AI assistance, as this is a medical device (dialyzer) and not an AI diagnostic tool.

6. Standalone Performance

A standalone performance evaluation was conducted in both non-clinical (in vitro) and clinical settings. The device's performance metrics (biocompatibility, ultrafiltration coefficient, clearances, and removal rates) were measured directly, independent of human interpretation beyond typical clinical monitoring.

7. Type of Ground Truth Used

• Non-clinical (In Vitro) Testing:
  • Biocompatibility: Standardized laboratory tests for cytotoxicity, sensitization, irritation, systemic toxicity, genotoxicity, hemocompatibility, and pyrogenicity, which have established scientific ground truths.
  • Performance (Kuf, Urea, Creatinine, Vitamin B12 clearances): In vitro measurements using outdated human blood, with ground truth established by laboratory analytical methods.
• Clinical Testing:
  • Performance (Kuf, Urea, Creatinine, Albumin removal rates): In vivo measurements in patients with chronic renal failure or acute renal failure. The "ground truth" for clinical performance was the patient's own initial dialysis session results, serving as a baseline for comparison with subsequent reused sessions. Outcome data included physiological measurements and patient stability.

8. Sample Size for the Training Set

The document does not explicitly describe a separate "training set" in the context of machine learning, as this is a medical device (dialyzer) evaluation, not an AI model development. The reported studies evaluate the device's performance directly.

9. How the Ground Truth for the Training Set Was Established

As there is no "training set" in the machine learning sense, this question is not applicable to the information provided. The evaluations are direct performance assessments of the dialyzer, not data used to train an algorithm.

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