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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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The CLIRANS® E-series Hollow Fiber Dialyzers are indicated for use whenever a patient is found to be in acute or chronic renal failure and hemodialysis is prescribed by a physician. The device should be used only at the direction of a physician who has evaluated all of the pertinent features of the patient's illness. This device is indicated for single use only.

The 2.0 m2 CLIRANS® E and EE Series dialyzers that are the subject of this 510(k) are a larger size (larger fiber surface area) of the currently cleared dialyzers (K003425).

Here's a breakdown of the acceptance criteria and study information based on the provided document:

Acceptance Criteria and Device Performance

The document describes the submission of Terumo Medical Corporation's CLIRANS® E-Series Dialyzers (specifically a larger 2.0 m² size) for substantial equivalence to existing predicate devices (CLIRANS® E-Series cleared under K003425 and Althin AF-220 cleared under K992573). The acceptance criteria are implicitly defined by demonstrating that the new device's performance is comparable to or better than the predicate devices across a set of physical and functional characteristics.

Note: The document explicitly states, "None of the data raises any new issues of safety and effectiveness." and "Differences between the devices do not raise any significant or new issues of safety or effectiveness." This implies the performance fell within acceptable limits relative to the predicate devices. Specific quantitative ranges or thresholds for the acceptance criteria are not provided in this document, as the submission focuses on demonstrating substantial equivalence rather than meeting pre-defined specific numerical targets for a novel device.

Study Details

The provided text describes a submission for substantial equivalence for a medical device (dialyzer) and primarily focuses on verification testing to demonstrate equivalence to predicate devices, rather than a clinical trial or algorithm performance study. Therefore, several of the requested sections are not applicable in the context of this document.

1. Sample Size used for the test set and the data provenance:

   • Sample Size: Not explicitly stated for each test but alluded to as "tests were performed." In-vitro verification tests typically use a batch or statistically significant number of units.
   • Data Provenance: The tests were "performed to demonstrate the substantial equivalence," suggesting a controlled, laboratory-based study, likely performed by the manufacturer (Terumo Medical Corporation). The country of origin of the data is implicitly the USA, where Terumo Medical Corporation is located. The study is prospective in the sense that these tests were conducted specifically for this 510(k) submission.

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

   • Not applicable. This is not a study requiring expert-established ground truth. The "ground truth" here is the established performance characteristics of the predicate devices.

3. Adjudication method for the test set:

   • Not applicable. This is not a study requiring expert adjudication.

4. 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 a study involving human readers or AI assistance. It concerns the performance of a physical medical device.

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

   • Not applicable. This is not an algorithm-based device.

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

   • The "ground truth" or reference standard for comparison is the known performance characteristics of the predicate devices. These characteristics would have been established through a combination of their own verification testing, clinical use data, and regulatory clearances. For biocompatibility, it's adherence to international standards (ISO-10993) and for sterilization, it's adherence to specific standards (ANSI/AAMI/ISO 11134 and EN 554).

7. The sample size for the training set:

   • Not applicable. This report does not describe a machine learning or AI-based device that would require a training set.

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

   • Not applicable. No training set is described.

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