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The line of APS Series Dialyzers is a family of high permeability hollow fiber dialyzers intended for the treatment of patient with acute or chronic renal failure. The APS Series Dialyzers are intended for both single use or for reuse with a maximum of 15 reprocessing reuse cycles per patient. This is the same intended use as the predicate device - APS Series Dialyzers cleared under K001250.

• APS Series Dialyzers are intended for use for hemodialysis treatment of patients who have chronic renal failure or acute renal failure.
• APS Series Dialyzers must be used in accordance with the instructions for a physician familiar with hemodialysis and familiar with the conditions of the patient.
• APS Series Dialyzers have been tested in vitro and in confirmatory clinical studies under single or initial use and under reprocessing and reuse conditions for up to 15 reuse cycles. Based on the results from these evaluations, Asahi APS 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 APS 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:
  • 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 these instruction for use and the instruction 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.
  • The reprocessing agent may be either (1) 4% formaldehyde (also known as formalin) in conjunction with the Seratronics Dialyzer Reprocessing Systems (DRS4TM and DPS4TM), manufactured by Seratronics, Inc., or (2) Renalin ® (peroxyacetic acid) in conjunction with the Renatron ® Dialyzer Reprocessing System (RS 8300), manufactured by Renal Systems, Inc.
  • The instructions provided by the manufacturer of the chosen reprocessing agent must be followed in reprocessing the dialyzer.
  • The reprocessed dialyzer may be used only on dialysis systems equipped with volumetric ultrafiltration controllers.

The line of Asahi Polysulfone (APS) Series Dialyzers is a family of high permeability hollow fiber dialyzers intended for the treatment of patients with acute or chronic renal failure. The Asahi APS Series Dialyzers are designed for both single use or for reuse with a maximum of 15 reprocessing reuse cycles per patient. They are constructed of reusable, hollow fiber (polysulfone) membranes, housed within a plastic casing of styrene butadiene block polymer and are gamma sterilized prior to shipment.

The Asahi APS Series Dialyzers are offered for sale in both a "wet" and a "dry" model. The wet and dry dialyzers are identical to each other except that the wet models filled at the factory with a fluid to facilitate priming by the user and the dry models are not filled. The use of a wet or dry dialyzer is a matter of user preference.

Modifications made to the Asahi APS Series Dialyzers subject of this 510(k) include (1) labeling revised to provide additional information concerning pre-cleaning; (2) modification of the dialyzer housing to diffuse the flow water used in pre-cleaning; and, (3) modification of the shipping carton partition materials and mold.

The acceptance criteria and study information is not available in the provided text. The document refers to "design verification tests" and "risk analysis" that "proved that those modifications to be appropriate" and that "All test results meet the acceptance criteria", but it does not specify what those criteria are or provide details about the study methodology, sample sizes, or ground truth establishment.

Here's a breakdown of what is mentioned concerning acceptance criteria and studies:

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

• Acceptance Criteria: Not explicitly stated. The document only mentions that "All test results meet the acceptance criteria."
• Reported Device Performance: Not explicitly detailed in numerical or quantitative terms in the provided text regarding specific tests. It generally states that the modified devices are "substantially equivalent in intended use, design, principle of operation/technology, materials, specifications and performance to the original APS Series Dialyzers."

2. Sample size 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 in the text.

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 provided in the text.

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

• This information is not provided in the text.

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 is a medical device (dialyzer), not an AI-assisted diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable and not mentioned.

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

• This is a medical device, not an algorithm. Therefore, a standalone algorithm performance study is not applicable and not mentioned.

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

• This information is not provided in the text. The document mentions "confirmatory clinical studies" in the Indications for Use, but these relate to reuse conditions, not device performance against a specific ground truth as would be relevant for a diagnostic device.

8. The sample size for the training set:

• This information is not provided in the text. (This would be relevant for AI/ML devices, which this is not.)

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

• This information is not provided in the text. (This would be relevant for AI/ML devices, which this is not.)

Summary of what is mentioned regarding the study:

• Study Type: "Design verification tests based on the result of risk analysis" and "confirmatory clinical studies" (related to reuse conditions).
• Methodology Basis: Risk analysis using procedures based on ISO 14971 (2000) Medical Devices -- Application of Risk Management to Medical Devices, specifically Failure Modes and Effects Analysis (FMEA).
• Outcome: All test results met acceptance criteria (unspecified), and proved that modifications made the device "substantially equivalent" to the predicate device. The clinical studies mentioned relate to in-vitro and in-vivo testing for single use and reuse conditions up to 15 cycles.

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• Asahi AM-BIO Extended Range (AM-BIO-HX series) Dialyzers are intended for use for hemodialysis treatment of patients who have chronic renal failure or acute renal failure.
• Asahi AM-BIO Extended Range (AM-BIO-HX series) Dialyzers must be used in accordance with the instructions of a physician familiar with hemodialysis and familiar with the conditions of the patient.
• Asahi AM-BIO Extended Range (AM-BIO-HX series) Dialyzers are intended for single use only.
• Asahi AM-BIO Extended Range (AM-BIO-HX series) Dialyzers are designed only to be used only on dialysis systems equipped with volumetric ultrafiltration controllers.
• The expiration date of ASAHI AM-BIO Extended Range (AM-BIO-HX series) Dialyzers is 3 years from the sterilization date. The user must use the dialyzers before the expiration date.

The line of Asahi AM-BIO Extended Range Series Dialyzers (AM-BIO-HX series) is a family of hemodialysis membranes, or hollow fiber dialyzers, developed to provide safe and effective hemodialysis over ranges of dialyzer patient treatment requirements. The device is intended for use in patients who have chronic renal failure or acute renal failure, for only single use. The membrane fibers are made of modified cellulose (i.e., alkyl ether polymer grafted cellulose), derived from cuprammonium rayon. The cuprammonium rayon is manufactured to have a thin layer of modified cellulose exposed to blood contact surfaces. The modification to the cellulose yields the fiber more compatible to the patient's blood, manifested through lower complement activation (C3g and C52) when compared to regular cellulose membrane dialyzers. The membranes are housed within a plastic casing of styrene butadiene block polymer. Non-removable casing end caps are also made of styrene butadiene block polymer. The potting material (sealant) is polyurethane and the port caps (stoppers) are made of hydrogenated styrene butadiene block polymer. Like the AM-BIO Series Dialyzers, the AM-BIO Extended Range Series Dialyzers will be offered for sale in both a "wet" model and a "dry" model. The wet and dry dialyzers are identical to each other except that the wet models are filled at the factory with a fluid to facilitate priming by the user and the dry models are not filled. The use of a wet or dry dialyzer is a matter of user preference. The fluid in wet dialyzers is made of water containing 600 ppm sodium pyrosulfite and 300 ppm sodium carbonate. Asahi AM-BIO Extended Range Series Dialyzers are sterilized by gamma radiation before shipment.

The provided text describes the Asahi AM-BIO Extended Range Series Dialyzers (AM-BIO-HX series) and its substantial equivalence to predicate devices, focusing on its intended use, design, manufacturing, and non-clinical testing. However, it does not contain detailed information about acceptance criteria or a study proving the device meets specific performance criteria in a format applicable to AI/ML device evaluations. The document is a 510(k) submission summary for a physical medical device (dialyzer), not a software or AI device.

Therefore, many of the requested elements for an AI/ML device evaluation, such as sample sizes for test/training sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or training set details, are not present.

Based on the provided text, here's what can be extracted and what cannot:

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

The document doesn't explicitly state quantitative acceptance criteria or reported performance values in a table format for the new device compared to specific thresholds. It mentions "extended range of performance specifications" due to a change in pore size, but no specific metrics are given.

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

Not applicable. The document describes non-clinical in-vitro testing and biocompatibility testing for a physical dialyzer, not a software device with a test set of 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)

Not applicable. This is for a physical device, not an AI/ML evaluation requiring expert-labeled ground truth for imaging or other data.

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

Not applicable. See above.

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 for a physical device, not an AI/ML device where human readers interact with AI.

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

Not applicable. This is a physical medical device.

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

Not applicable. For the in-vitro tests mentioned (like permeability, clearance rates, cytotoxicity), the "ground truth" would be established by standard laboratory measurement techniques and scientific principles for each specific test parameter, not by expert consensus or pathology in the context of an AI/ML dataset.

8. The sample size for the training set

Not applicable. The device is a physical dialyzer, not an AI/ML model that is "trained."

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

Not applicable. See above.

Summary based on the provided document:

The provided text describes the Asahi AM-BIO Extended Range Series Dialyzers as substantially equivalent to existing predicate devices (Asahi AM-BIO Series Dialyzers, Asahi APS Series Dialyzer, Fresenius Hemoflow). The equivalence is based on similar indications for use, design, and manufacturing, with the new device offering an "extended range of performance specifications" by changing the pore size of the dialyzer fibers.

The "study" equivalent to proving the device meets acceptance criteria in this context is the non-clinical in-vitro testing and biocompatibility testing.

Non-Clinical Testing Performed:

• In-vitro testing:
  • Permeability - saline
  • Permeability - bovine plasma
  • Urea clearance rate
  • Creatinine clearance rate
  • Phosphate clearance rate
• Biocompatibility testing:
  • Cytotoxicity
  • Sensitization
  • Irritation or Intracutaneous Reactivity
  • Systemic Toxicity (Acute)
  • Genotoxicity
  • Hemocompatibility
  • Pyrogenicity

Acceptance Criteria & Performance:

The document implies that the results of these tests met accepted standards for dialyzer performance and safety, allowing the device to be deemed "substantially equivalent" by the FDA. However, specific quantitative acceptance criteria (e.g., "urea clearance must be > X mL/min") and the exact reported performance values are not detailed in this summary document. It states that the device has "extended range of performance specifications," suggesting that its performance in the tested parameters would either meet or exceed the predicate devices.

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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-BIO Series Dialyzers are intended for use for hemodialysis treatment of patients who have chronic renal failure or acute renal failure. Asahi AM-BIO Series Dialyzers must be used in accordance with the instructions of a physician familiar with hemodialysis and familiar with the conditions of the patient. Asahi AM-BIO Series-Dialyzers have been tested in vitro and in confirmatory clinical studies under single or initial use and under reprocessing and reuse conditions for up to 15 reuse cycles. Based on the results from these evaluations, Asahi AM-BIO 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-BIO 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 these 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 Dialyzer Reprocessing Systems for Dialyzer Reprocessing and Preparation (DRS4" and DPS4"), manufactured by Seratronics, Inc., or (2) Renalin® in conjunction with the Renatron® Dialyzer Reprocessing System (RS 8300), manufactured by Renal Systems, Inc. 3. The instructions provided by the manufacturer of the chosen reprocessing agent must be followed in reprocessing the dialyzer. 4. The reprocessed dialyzer may be used only on dialysis systems equipped with volumetric ultrafiltration controllers.

The line of Asahi AM-BIO Series Dialyzers is a family of hemodialysis membranes, or hollow fiber dialyzers developed to provide safe and effective hemodialysis over ranges of dialyzer patient treatment requirements. The device is intended for use in patients who have chronic renal failure or acute renal failure, for both single or initial use and when reprocessed for reuse for a maximum of 15 reprocessing reuse cycles on the same patient. The membrane fibers are made of modified cellulose (i.e., alkyl ether polymer grafted cellulose), derived from cuprammonium rayon. The cuprammonium rayon is manufactured to have a thin layer of modified cellulose exposed to blood contact surfaces. The modification to the cellulose yields the fiber more compatible to the patient's blood, manifested through lower complement activation (C3, and C5,) when compared to regular cellulose membrane dialyzers. The membranes are housed within a plastic casing of styrene butadiene block polymer. Nonremovable casing end caps are also made of styrene butadiene block polymer. The potting material (sealant) is polyurethane and the port caps (stoppers) are made of hydrogenated styrene butadiene block polymer. The AM-BIO Series Dialyzers will be offered for sale in both a "wet" model and a "dry" model. The wet and dry dialyzers are identical to each other except that the wet models are filled at the factory with a fluid to facilitate priming by the user and the dry models are not filled. The use of a wet or dry dialyzer is a matter of user preference. The fluid in wet dialyzers is made of water containing 600 ppm sodium pyrosulfite and 300 ppm sodium carbonate. All Asahi AM-BIO Series Dialyzers are sterilized before shipment by gamma radiation (y-rays). The dialyzer is no longer sterile after it is accessed for the initial use.

Here's a breakdown of the acceptance criteria and the study details for the Asahi AM-BIO Series Dialyzers, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set (Clinical Study):

  • Sample Size: 12 patients per clinical site. The study aimed for each patient to be treated 36 consecutive times, reusing the dialyzer up to 15 times on each subject.
  • Data Provenance: Prospective, from two clinical sites (country of origin not explicitly stated, but the company is Japanese and the submission to the FDA, suggesting US or international involvement).

• Test Set (In vitro study):

  • Sample Size: Not explicitly stated as a number of individual dialyzers, but involved "the smallest wet model (AM-BIO-50) and the largest wet model (AM-BIO-100)" tested with 15 reprocessing cycles.
  • Data Provenance: Used "outdated human blood from a blood bank".

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

The document does not explicitly state the number of experts or their qualifications for establishing ground truth within the clinical or in-vitro tests conducted for this 510(k) submission. Clinical measurements were taken, and general "established dialysis practices" were followed at the institutions. However, the overall "ground truth" for product safety and effectiveness in K983720 is based on substantial equivalence to predicate devices, which themselves would have been cleared based on existing medical consensus on hemodialysis.

4. Adjudication Method for the Test Set

The document does not mention a formal adjudication method (like 2+1 or 3+1 consensus) for the clinical study's outcomes. Clinical measurements (Kur, removal rates, complement activation) were likely gathered and analyzed according to the study protocol.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, an MRMC comparative effectiveness study was not done. This device is a medical device (dialyzer) for organ support, not an AI or imaging diagnostic software that typically involves human reader performance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, the performance of the dialyzer itself (the "algorithm" in this context) was evaluated in standalone in-vitro and clinical studies without human-in-the-loop performance influencing its function. Humans operate the reprocessing systems and dialysis machines, but the device's efficacy (filtration, biocompatibility) is an intrinsic property.

7. The Type of Ground Truth Used

• For in-vitro testing: Measured physical and chemical parameters (Kur, clearances for urea, creatinine, B12) using standard laboratory methods, established as "ground truth" through direct measurement.
• For clinical testing:
  • Performance: Clinical measurements of Kur, removal rates for urea, creatinine, and albumin, which serve as direct, objective "ground truth" for the device's function in a patient setting.
  • Safety/Biocompatibility: Monitoring of complement activation (C3a and C5a) and characterization of patient effects over 36 treatments provide "ground truth" for the device's safety profile.
  • Overall: Substantial equivalence to predicate devices, meaning the "ground truth" for overall safety and effectiveness is largely benchmarked against well-established and legally marketed hemodialyzers.

8. The Sample Size for the Training Set

The concept of a "training set" is not applicable here, as this is a medical device (dialyzer), not an AI algorithm. The device's design and manufacturing process are based on established engineering principles and prior research, not a machine learning training paradigm.

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

Not applicable, as there is no "training set" in the context of an AI algorithm. The design of the dialyzer and its membrane material (modified cellulose) were engineered to achieve specific performance characteristics and enhanced hemocompatibility, likely based on R&D, material science, and prior knowledge of hemodialysis.

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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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