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HEMOCLEAN® is intended for the disinfection of artificial kidney machines (hemodialysis machines). It should be used under the following the dilution rate and contact condition:

HEMOCLEAN® is a single component germicide that does not require mixing or activation. HEMOCLEAN® is a stabilized mixture of hydrogen peroxide 5.3%(<6.0%) and peracetic acid 1.7%; inert ingredients are 93%. The product is a clear colorless liquid, high acid, and completely soluble in water. HEMOCLEAN® finally breaks down to carbon dioxide, water, and oxygen. The product is used full strength with automated dilution by the hemodialysis machine for the intended use. It is packaged in five liters polyethylene containers with a vent filter on the cap and is shipped in two 5-liter containers per box. The shelf life of the concentrate is one year when properly stored.

HEMOCLEAN® is indicated for the disinfection of hemodialysis machines. To use HEMOCLEAN® in automated hemodialysis machines, the user should follow the manufacture's recommendations for dilution of peracetic acid-based disinfectants. AAMI-quality water for hemodialysis must be used for diluting HEMOCLEAN® in the hemodialysis machine.

The provided text describes the device HEMOCLEAN®, a germicide for hemodialysis machines, and references non-clinical and clinical tests performed during its 510(k) submission. However, the document does not contain specific acceptance criteria with numerical targets or detailed results that demonstrate how the device "meets" those criteria in a quantitative sense as typically seen for AI/ML device performance.

Instead, the submission focuses on establishing substantial equivalence to a predicate device (Minntech/Renal Systems Actril®) by demonstrating similar technological characteristics and performance for its intended use as a hemodialysis machine disinfectant. The "acceptance criteria" appear to be implicit in demonstrating safety and effectiveness comparable to the predicate device.

Here's an analysis based on the information provided, attempting to fit it into the requested structure:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not explicitly stated. The document mentions "In vitro performance testing" and "Testing was performed in a dialysis clinic in hemodialysis machines," but does not provide details on the number of runs, machines, or specific samples tested for these assessments.
• Data Provenance: The "clinical test results" were from "a dialysis clinic." The country of origin for the data is not specified, but the submitter (KRD CO., LTD.) is based in Korea. The submission date is March 29th, 2004, indicating retrospective data collection relative to the submission.

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

This information is not provided in the document. The concept of "ground truth established by experts" is more common for diagnostic imaging or AI/ML evaluations. For a chemical germicide, performance is typically assessed through standardized microbiological testing and chemical analysis, rather than expert consensus on subjective findings.

4. Adjudication Method for the Test Set

This information is not applicable/provided. Adjudication methods (like 2+1, 3+1) are typically used in studies involving human interpretation (e.g., radiologist reads) to establish a consensus ground truth. This is not described for the testing of HEMOCLEAN®.

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

This information is not provided and is not applicable to this type of device. MRMC studies evaluate the performance of human readers, sometimes with and without AI assistance, for diagnostic tasks. HEMOCLEAN® is a chemical disinfectant, not a diagnostic imaging device.

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

This information is not applicable as HEMOCLEAN® is a chemical germicide, not an algorithm or AI/ML device. Its performance is chemical and biological efficacy.

7. The Type of Ground Truth Used

The "ground truth" for a chemical disinfectant would typically be established through:

• Microbiological assays: Demonstrating specified log reductions of various microorganisms (bacteria, spores, fungi, viruses) under defined conditions.
• Chemical analysis: Confirming the breakdown of the disinfectant into non-toxic components and verifying residual levels are within safe limits.
• Predicate device comparison: Using the established performance characteristics and safety profile of the legally marketed predicate device (Actril®) as a benchmark.

The document indicates "In vitro performance testing" and "Testing was performed in a dialysis clinic in hemodialysis machines," which would likely involve these types of ground truth assessments, though specific metrics are not detailed.

8. The Sample Size for the Training Set

This information is not applicable as HEMOCLEAN® is a chemical germicide, not an AI/ML device that undergoes "training."

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

This information is not applicable for the same reason as above.

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