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VIE-U is intended for use in hemodialysis for the treatment of patients who have acute or chronic renal failure. ViE-U is intended for single use only.

The ViE-U is a high flux hollow fiber hemodialyzer. The device is sold sterile and is intended for single use only. All the materials including the hollow fiber membrane, housing, headers, potting material and stoppers are identical to those previously cleared in the predicate device (APS). The additional coating of vitamin E on the hollow fiber membrane uses an equivalent material and technology to the predicate device (CLIRANS).

This document is a 510(k) summary for a medical device (dialyzer), not an AI/ML-driven device, therefore, many of the requested criteria are not applicable. I will extract the relevant information regarding performance testing and acceptance criteria as described in the document.

Acceptance Criteria and Device Performance (Based on available information regarding device testing):

The document primarily focuses on demonstrating substantial equivalence to predicate devices, rather than setting specific numerical acceptance thresholds for independent performance metrics for this
Submission documents for medical devices (especially 510(k)s) don't always contain explicit tables of acceptance criteria and performance data in the way one might expect for an AI/ML model where specific sensitivity, specificity, or AUC targets are set. Instead, for devices like dialyzers, performance is demonstrated through a series of tests to show it meets required standards and is equivalent to previously approved devices.

Here's a breakdown of the performance data reported based on the provided text, and how acceptance criteria are implied or stated:

Table of Acceptance Criteria and Reported Device Performance (Implied from the text):

• Clearance (urea, creatinine, phosphate, vitamin B12 at blood flow rates 200-500 mL/min.)
• Pressure drop
• Kuf
• Priming volume (Blood compartment volume)
• Maximum TMP |
  | Sterilization Validation (ISO 11137-2) | Conformance to ISO 11137-2. | Performed per ISO 11137-2. |
  | Pyrogenicity Testing | Passing pyrogenicity test. | Testing performed. (Result implied as successful, given overall conclusion of substantial equivalence). |
  | Expiration Date Testing | Device maintains performance until expiration. | Testing performed. (Result implied as successful). |
  | Packaging & Transportation Testing (ASTM D4169-14) | Conformance to ASTM D4169-14. | Performed per ASTM D4169-14. |
  | Clinical Performance (In vivo) | Equivalence to control dialyzer for ultrafiltration coefficient (KuF) and removal rates for urea, albumin, and beta 2-microglobulin. | Evaluation showed equivalence of the ViE-21U and control dialyzers. Specifically, in vivo KuF and removal rates for urea, albumin, and beta 2-microglobulin were evaluated. The clinical performance and biocompatibility evaluation showed equivalence of the ViE-21U and control dialyzers. |
  | Clinical Safety | Acceptable safety profile, comparable to control dialyzer, with no serious related adverse events. | Two possible related adverse events (pruritus and full body rash) occurred in one patient, resolved without sequelae. No serious adverse events determined to be related to the ViE-21U. The device was shown to be safe as compared to the control dialyzer. |

(2) Sample size used for the test set and the data provenance:

• Test Set Sample Size:
  • Clinical Study: 17 patients enrolled.
  • Clinical Performance & Biocompatibility Evaluation: 12 patients (those who completed all 36 sessions with the ViE-21U dialyzer).
  • Safety Evaluation: All 17 enrolled patients.
• Data Provenance:
  • Country of Origin: Canada (single site).
  • Retrospective or Prospective: Prospective.

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

• Not Applicable. This document describes a clinical study for a medical device (dialyzer), not an AI/ML system that requires expert annotation for ground truth. The 'ground truth' for performance assessment would be the objective measurements from the in vitro and in vivo testing, compared against established standards or a control device.

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

• Not Applicable. As this is a medical device performance study and not an AI/ML model requiring human consensus for ground truth, there is no mention of an adjudication method. Data would be collected, and its validity based on standard statistical and clinical methodology.

(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, and no human reader comparative effectiveness study was performed. The study compared the device (ViE-U) to a control dialyzer.

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

• Partially Applicable (but not for an algorithm). The device itself operates "stand-alone" in terms of its function (dialysis), in that it does not involve human-in-the-loop assistance in the way an AI diagnostic tool would. However, its overall effectiveness is measured in the context of patient treatment, involving healthcare professionals. The in vitro and in vivo clinical studies assessed the device's function directly.

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

• Primary Ground Truth:
  • In vitro performance: Objective measurements against ISO 8637 standards (e.g., clearance rates, pressure drops, Kuf, priming volume, maximum TMP).
  • Clinical Performance: Direct physiological measurements (e.g., ultrafiltration coefficient (KuF), removal rates for urea, albumin, beta 2-microglobulin), compared against a control dialyzer.
  • Biocompatibility: Measurements of biological markers (e.g., white blood cells, platelets, complement activation).
  • Safety: Incidence and type of adverse events.
  • Material Equivalence: Chemical and physical analysis of materials.

(8) The sample size for the training set:

• Not Applicable. This is not an AI/ML device and therefore does not have a "training set" in the context of machine learning.

(9) How the ground truth for the training set was established:

• Not Applicable. As this is not an AI/ML device, there is no "training set" requiring ground truth establishment in that context.

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REXEED-S Series Dialyzer is intended for use in hemodialysis for the treatment of patients suffering from acute or chronic renal failure.

The line of Asahi REXEED-S Series Dialyzer (hereafter referred to as REXEED-S) is a family of high permeability hollow fiber dialyzers intended for the treatment of patients with acute or chronic renal failure.

REXEED-S is designed for single use.

REXEED-S is constructed of hollow fiber membrane housed within a plastic housing of Styrene-Butadiene block copolymer and is subject to gamma-ray irradiation prior to shipment.

This document is a 510(k) summary for a medical device called the Asahi REXEED-S Series Dialyzer, which is a high-permeability hemodialysis system. The submission describes modifications to the device's materials, specifically in the housing and stoppers, and aims to demonstrate substantial equivalence to previously cleared versions of the same device. Therefore, the "acceptance criteria" discussed are largely related to design verification rather than diagnostic performance metrics (like sensitivity, specificity, etc.) that would typically apply to an AI/ML medical device.

Based on the provided text, here's a breakdown of the requested information, focusing on the context of this specific device and submission:

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

Specific numerical acceptance criteria and performance values are not detailed in this summary document. The document states that "All test results met the acceptance criteria, and proved those modifications to be appropriate."

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

The document does not specify the sample size used for the test set or the data provenance. It refers generally to "Design verification tests."

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 document. Given that this is a material and design modification for a physical device, the "ground truth" would likely be established through engineering specifications, material science testing, and possibly clinical performance data (though not explicitly detailed here). The experts would be engineers, material scientists, and potentially medical professionals involved in hemodialysis.

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

Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in diagnostic studies involving expert review. This is not applicable to this type of device modification submission, which focuses on engineering and material performance.

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

MRMC studies are relevant for diagnostic AI/ML devices. This is a submission for a physical medical device (dialyzer) with material modifications, so an MRMC study is not applicable and was not performed.

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

"Standalone" performance is relevant for AI/ML algorithms. This is a submission for a physical medical device, so this concept is not applicable.

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

For this device modification, the "ground truth" was established through:

• Engineering specifications: Standards for material properties, mechanical integrity, and functional performance (e.g., filtration rates, solute clearance).
• Material testing: Chemical and physical analysis of the new materials.
• Biocompatibility testing: To ensure safety when in contact with blood.
• Risk analysis (FMEA): To identify and mitigate potential failure modes.

8. The sample size for the training set

This concept is relevant for AI/ML models. This is a physical device, so there is no "training set" in the AI/ML sense. Design verification and validation are based on testing prototypes and production samples.

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

As there is no AI/ML "training set" for this device, this question is not applicable. The "ground truth" for verifying the device's performance (as described in point 7) was established through established engineering and scientific methodologies.

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A. REXEED-SX/LX Dialyzers is intended for use for hemodialysis treatment of patients who have chronic or acute renal failure.
B. REXEED SX/LX Dialyzers must be used in accordance with the instructions for a physician familiar with hemodialysis and familiar with the conditions of the patient.
C. REXEED SX/LX Dialyzers have been tested in vitro under single use conditions.

The line of Asahi REXEED-SX/LX Series Dialyzer is a family of high permeability hollow fiber dialyzers intended for the treatment of patients with acute or chronic renal failure. REXEED-SX/LX Series Dialyzer is designed for single use. REXEED-SX/LX Series Dialyzer is constructed of hollow fiber (polysulfone) membranes, housed within a plastic casing of styrene-butadiene block copolymer and are subjected to electron beam irradiation prior to shipment.

The provided 510(k) summary for the Asahi REXEED-SX/LX Series Dialyzer describes modifications to an already cleared device and focuses on proving that these modifications do not compromise the device's safety and effectiveness compared to the predicate device. It is not a study establishing initial device performance against specific clinical acceptance criteria.

Therefore, the requested information elements related to a study proving the device meets acceptance criteria, such as a table of performance, sample sizes for test sets, expert ground truth, adjudication methods, MRMC studies, or standalone performance, are not applicable or available in this document. The submission is a "Special 510(k)," which typically focuses on demonstrating that modifications do not raise new questions of safety or effectiveness.

Here's an analysis of the available information:

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

• Not Applicable/Not Provided. This submission is for modifications to an already cleared device. The document states, "All test results meet the acceptance criteria, and proved that those modifications to be appropriate," but it does not specify what those acceptance criteria were or present a table of results against them. The focus is on demonstrating that the modifications do not negatively impact performance, rather than establishing initial performance metrics.

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/Not Provided. The document refers to "design validation or where appropriate, design verification, and process validation" studies. However, it does not specify the sample sizes or provenance of data used in these studies. These are typically internal engineering tests rather than clinical studies.

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/Not Provided. There is no mention of expert-established ground truth for a test set, as this is not a diagnostic device involving human interpretation.

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

• Not Applicable/Not Provided. Not relevant for the type of device and 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:

• Not Applicable. This is a hemodialysis dialyzer, not a diagnostic device involving human readers or AI assistance.

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

• Not Applicable. This is a hardware medical device; it does not involve algorithms or AI.

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

• Not Applicable/Not Provided. The "ground truth" for a hemodialysis dialyzer would generally relate to its physical properties, manufacturing quality, and in-vitro performance (e.g., blood compatibility, filtration rates, structural integrity, absence of leakage). The document states, "REXEED SX/LX Dialyzers have been tested in vitro under single use conditions," indicating in vitro performance data would be the primary "ground truth" equivalent.

8. The sample size for the training set:

• Not Applicable. This is not a machine learning or AI device that requires a training set.

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

• Not Applicable. Not a machine learning or AI device.

Summary of what is provided:

• Acceptance Criteria Mention: The document states that "All test results meet the acceptance criteria, and proved that those modifications to be appropriate." However, the specific acceptance criteria themselves are not detailed in this public summary. They would be part of the full submission, likely related to manufacturing quality, physical properties (e.g., leakage, hollow fiber specifications), and in vitro performance (e.g., clearance rates, ultrafiltration rates, biocompatibility).
• The Study/Evaluation: The "study" is referred to as "Asahi's device evaluation studies and overall process for managing medical device risk," which includes a risk analysis (FMEA) and "Design validation or where appropriate, design verification, and process validation." These studies were performed to verify the impact of the described modifications (manufacturing process change, labeling change, and device modification related to leakage and physical properties).
• Purpose of the Study: To establish that the modified Asahi REXEED-SX/LX Series Dialyzer is substantially equivalent in intended use/indications for use, design, principle of operation, technology, materials, specifications, and performance to the predicate REXEED-SX/LX Series Dialyzer. The predicate devices were previously cleared under K001250, K041726, K051187, and K082515.

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A. REXEED-SX/LX Dialyzers is intended for use for hemodialysis treatment of patients who have chronic or acute renal failure.
B. REXEED SX/LX Dialyzers must be used in accordance with the instructions for a physician familiar with hemodialysis and familiar with the conditions of the patient.
C. REXEED SX/LX Dialyzers have been tested in vitro under single use conditions.

The line of Asahi REXEED-SX/LX Dialyzers is a family of high permeability hollow fiber dialyzers intended for the treatment of patients with acute or chronic renal failure. REXEED-SX/LX Dialyzers are designed for single use. REXEED-SX/LX Dialyzers are constructed of hollow fiber (polysulfone) membranes, housed within a plastic casing of styrene-butadiene block copolymer and are subject to electron beam irradiation prior to shipment.

This Special 510(k) describes the following modifications:

• Change in wall thickness of the polysulfone REXEED-SX/LX hollow fibers to 35 um, compared to 45 um for the existing predicate APS/REXEED
• Change in priming procedure to REXEED-SX/LX priming procedure (drytype) from APS/REXEED priming procedure (wet-type)
• Change in sterilization type to electron beam irradiation REXEED-SX/LX Dialyzers, compared to gamma radiation for the existing predicate APS/REXEED
• Change in use to REXEED-SX/LX is available for single use from APS/REXEED which is available for single use and reuse.

This document describes a 510(k) premarket notification for the Asahi REXEED-SX/LX Dialyzers. The focus of the information provided is on demonstrating substantial equivalence to pre-existing predicate devices following certain modifications, rather than a study proving the device meets specific acceptance criteria in a clinical setting with human subjects.

Therefore, many of the requested categories related to clinical study design, ground truth establishment, expert adjudication, and comparative effectiveness with AI assistance are not applicable based on the provided text. The document primarily outlines the engineering and risk management aspects of the device modifications.

Here's an attempt to extract relevant information for the applicable categories:

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

The document states: "All test results meet the acceptance criteria, and proved that those modifications to be appropriate."
However, it does not explicitly list specific acceptance criteria values or detailed performance metrics for the REXEED-SX/LX Dialyzers in a table format within the provided text. It generally refers to "design verification tests based on the result of risk analysis and design input" and that these tests met acceptance criteria.

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 for Test Set: Not specified.
• Data Provenance: The studies are described as "in vitro" ("REXEED SX/LX Dialyzers have been tested in vitro under single use conditions."). The company is based in Japan, so it's likely the tests were conducted there or at facilities contracted by the company. Retrospective or prospective nature is not indicated, but given it's a device modification verification, it would be prospective testing of the modified device.

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)

• Number of Experts: Not applicable. The "ground truth" here relates to engineering and performance specifications validated through testing, not clinical diagnosis.
• Qualifications of Experts: Not applicable.

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

• Adjudication Method: Not applicable. This concept is for clinical assessments, not for engineering verification tests.

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

• MRMC Study: No. This is not an AI/imaging device.

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

• Standalone Performance: Not applicable. This is not an algorithm or AI device.

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

• Type of Ground Truth: The "ground truth" for this device modification review is based on engineering specifications, risk analysis (FMEA), and benchmark performance against the predicate device as demonstrated through "design verification tests." These tests would likely involve measuring physical and functional properties of the dialyzers according to established standards for hemodialysis systems.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. This is not a machine learning or AI device.

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

• How Ground Truth for Training Set was Established: Not applicable.

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REXEED Series Dialyzers is intended for use for hemodialysis treatment of patients who have chronic or acute renal failure. REXEED Series Dialyzers must be used by a physician familiar with hemodialysis and under single or initial use conditions. REXEED Series Dialyzers have been evaluated under reprocessing and reuse conditions for all REXEED-UR/R Series Dialyzers. Based on the results from these evaluations, REXEED-UR/R Series Dialyzers may be reprocessed for reuse on the same patient. If reprocessing Series Dialyzers may be reprocessed for reuse on the same patient. If reprocessing is elected, it is recommended that the reuse be done under the conditions as existed in the in vitro and confirmatory clinical studies as conditions as "Existed" in "the "in "the "ht" "ht" "hat REXEED-UR/R Series Dialyzers recommisinced inimediately corrent 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 The reprocessed that 20% of the original TCV and if such dialyzer otherwise meets (TCV) is at least 60% of these instruction for use and the instruction of the the acceptance officilized. Furthermore, the policies, instructions, and criteria reprocessing system annized. Furthernore, mag dialyzer performance, residual of the ind/or dialyzer leakage or damage) should be followed.
(2) The reprocessing agent may mixture of hydrogen peroxide and peroxyacetic The reprocessing agent may intinues of 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 REXEED Series Dialyzers (hereinafter called REXEED) is a family of high permeability hollow fiber dialyzers intended for the treatment of patients with acute or chronic renal failure. REXEED-U/S are designed for single use and REXEED-UR/R are designed for reuse. The REXEED dialyers are constructed of reusable hollow fiber (polysulfone) membranes, housed within a plastic casing of styrene butadiene block copolymer and are gamma sterilized prior to shipment.

Modifications made in this 510(k) including the followings. (1) The shape modification of polysulfone hollow fibers to the crimped was implemented. The REXEED dialyzers with crimped hollow fibers is added to the existing APS Series Dialyzers (hereafter called APS) cleared under K001250 and; (2) the REXEED dialyzers membrane surface area ranges from 1.5m² to 2.5m², while that of APS ranges from 0.8 m² to 2.1 m² and; (3) mixture of hydrogen peroxide and peroxyacetic acid (e.g., Renalin®) is used as reprocessing agent) and; (4) accordingly, change in the Instruction For Use (IFU) in regard to reprocessing agent.

The provided text describes modifications to the Asahi REXEED Series Dialyzers and their substantial equivalence to predicate devices, but it does not contain a detailed study report with specific acceptance criteria and performance data in a table format, nor does it include information on sample sizes for test and training sets, expert qualifications, or MRMC studies.

Based on the available information, here's what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Not available in the provided text. The document states:

"All test results meet the acceptance criteria, and proved that those modifications to be appropriate."
and
"All design verification tests based on the result of risk analysis and design input proved that the REXEED dialyzers are substantially equivalent in intended use, design, principle of operation, technology, materials, specifications, and performance to the existing APS cleared under K001250 and K041726, Fresenius Optiflux F200A cleared under K003498, and Gambro Polyflux 24S and Polyflux 24R cleared under K010667, with the exception of using mixture of hydrogen peroxide and peroxyacetic acid (e.g., Renalin®)."

This indicates that acceptance criteria were met, but the specific criteria and quantitative performance results are not detailed.

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

Not available in the provided text. The document mentions "Design verification tests," but does not specify the sample size or the nature of the data (e.g., in vitro, animal, human; country of origin; retrospective or prospective).

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

Not applicable. The document describes a device modification verification, not a study involving expert-established ground truth for a diagnostic AI device.

4. Adjudication Method for the Test Set

Not applicable, as there's no mention of a test set requiring adjudication in the context of expert consensus.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC study was not done. This type of study is typically for evaluating diagnostic performance of an AI system with human readers, which is not the context of this device modification submission.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is a medical device (dialyzer) modification, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" in this context refers to the established performance and safety parameters of the predicate devices. The modifications were evaluated against "design verification tests based on the result of risk analysis and design input" to prove substantial equivalence to these predicate devices.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device.

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

Not applicable. This is not an AI/machine learning device.

Summary of available and missing information:

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