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Revaclear™ 300 and 400 dialyzers are indicated for treatment of chronic and acute renal failure by hemodialysis.

This device is intended for the treatment of chronic and acute renal failure by hemodialysis.
The intended population of this device is identical to those of the Polyflux HD-C4 (BIG), cleared for marketing in the United States under 510(k) notification K060195 and Polyflux HD-C4 (Small), cleared for marketing in the United States under 510(k) notification K072232.
The membrane used in this device is a blend of polyarylethersulfone (PAES) and polyvinylpyrrolidone (PVP), which is equivalent to the membrane utilized in the Gambro Polyflux HD-C4 (BIG) and Polyflux HD-C4 (Small) single use hemodialyzers cleared for marketing in the United States under 510(k) Notifications (K060195 and K072232).
Blood enters a blood inlet port where it is distributed to the hollow fibers. The patient's blood traverses the inside of the hollow fibers and exits the device via a blood exit port. By means of a hydrostatic pressure or transmembrane pressure which is created by a combination of positive and negative pressures across the membrane, plasma water along with certain lower and middle molecular weight solutes pass through the membrane and into the dialysate or filtrate compartment of the device. Uremic toxins and waste products are removed from the patient's blood in this device by means of both diffusion and convection through the membrane and into the countercurrent flowing dialysis solution during hemodialysis. The dialysate exits the devices via a dialysate outlet port.

Here's an analysis of the acceptance criteria and study detailed in the provided K130039 document for the Gambro Revaclear™ 300 and 400 Dialyzer:

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

The document does not explicitly state numerical "acceptance criteria" against which a single "reported device performance" is measured in a clear, tabular format. Instead, it states that performance was determined according to ISO 8637 and compared to predicate devices, and that the device did not induce any adverse biological effects.

However, based on the information provided, we can infer the acceptance criteria and summarize the reported findings for comparability.

Inferred Acceptance Criteria and Reported Device Performance for Gambro Revaclear™ 300 and 400 Dialyzer

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

• In Vitro Performance Testing:

  • Sample Size: Not explicitly stated in the summary, but it notes that "Detailed measurement results are provided in Section 17."
  • Data Provenance: Not specified, but generally, in vitro testing is conducted in a laboratory setting, not usually tied to a specific country of origin in the same way clinical data is. It's prospective in nature for device evaluation.

• Biocompatibility Evaluation:

  • Sample Size: Revaclear 400 was chosen as a "master product" for testing, implying it represents the product family. The specific number of samples tested is not provided in this summary.
  • Data Provenance: Not specified, but similar to in vitro testing, it's typically prospective lab testing.

• Mechanical Hemolysis:

  • Sample Size: "three experiments. In each experiment three filters were tested in parallel" (i.e., at least 9 filters tested in total for Revaclear 300 and predicate devices).
  • Data Provenance: Not specified, likely prospective lab testing.

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 section is Not Applicable (N/A).
The studies described are non-clinical (in vitro, biocompatibility, mechanical hemolysis) and do not involve human subject data requiring expert interpretation or ground truth establishment in the way clinical diagnostic studies do. The "ground truth" for these tests is the objective measurement against established standards (ISO 8637, ISO 10993) and comparison to predicate device performance.

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

This section is Not Applicable (N/A).
Adjudication methods like 2+1 or 3+1 are used in clinical studies, particularly in image interpretation, to resolve discrepancies between readers. The studies described are non-clinical performance and safety tests, not clinical evaluations involving human readers.

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 section is Not Applicable (N/A).
No MRMC study was conducted. The device is a physical medical device (dialyzer), not an AI-powered diagnostic tool. The document explicitly states "Summary of Clinical Tests: N/A".

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

This section is Not Applicable (N/A).
The device is a physical medical device, not an algorithm.

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

As described in point 3, the concept of "ground truth" as it applies to clinical diagnostic studies is not directly relevant here. However, the closest equivalent is:

• In Vitro Performance: Compliance with ISO 8637 physical and chemical specifications and performance metrics (clearances, flow resistance, ultrafiltration coefficient) of the legally marketed predicate devices.
• Biocompatibility: Adherence to ISO 10993-1 and FDA Memorandum G-95-1 standards for biological endpoints (cytotoxicity, sensitization, systemic toxicity, genotoxicity, hemocompatibility) and characterization of materials and leachables based on chemical analysis.
• Mechanical Hemolysis: Measurement of free hemoglobin levels against established scientific principles indicating hemolysis, and comparison to the predicate device's performance.

8. The sample size for the training set

This section is Not Applicable (N/A).
There is no "training set" in the context of this device's evaluation. Training sets are relevant for AI/machine learning models where data is used to teach the algorithm. This document describes the testing of a physical medical device.

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

This section is Not Applicable (N/A).
As there is no training set, there is no ground truth for a training set.

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