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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%(

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

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