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Acecide High-Level Disinfectant and Sterilant is intended to be used for the automated sterilization or high-level disinfection of clean, heat sensitive, critical or semi-critical medical devices that are not compatible with other sterilization or high-level disinfection processes that can be biologically monitored.

Acecide High-Level Disinfectant and Sterilant should be used under the following contact conditions:

Sterilization: Time 5 hours, Temperature 25°C, Minimum Recommended Concentration of Peracetic Acid 1900 ppm
High-Level Disinfection: Time 5 minutes, Temperature 25°C, Minimum Recommended Concentration of Peracetic Acid 1900 ppm

Acecide Peracetic Acid Test Strips are intended for verifying the minimum recommended concentration of peracetic acid in Acecide High-Level Disinfectant and Sterilant during reuse.

Acecide High-Level Disinfectant and Sterilant is a germicide that requires the combination of two parts, Solution 1 and Solution 2, within the Solution 2 bottle. The product is used full strength without dilution. It is packaged in two High Density Polyethylene bottles.

The active ingredients in Acecide High-Level Disinfectant and Sterilant are peracetic acid and hydrogen peroxide. As discussed in Block's article, the mechanism of microbial action is believed to be oxidizing sulthydryl and sulfur bonds on proteins and enzymes, particularly in the cell walls.

Acecide Peracetic Acid Test Strops are provided to verify that the minimum recommended concentration, 1900 ppm peracetic acid (PAA) of Acecide High-Level Disinfectant and Sterilant is present.

The provided text describes the regulatory submission for the Acecide™ High-Level Disinfectant and Sterilant and Acecide™ Peracetic Acid Test Strips. It outlines the efficacy testing performed for the disinfectant and sterilant, and the performance of the test strips.

Here's a breakdown of the requested information:

1. Table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance

• Acecide High-Level Disinfectant and Sterilant - Efficacy Testing:
  • Sporicidal: Three lots of Acecide High-Level Disinfectant and Sterilant were used for AOAC sporicidal testing. Sporicidal simulated-use testing was also performed on endoscopes (specific number of endoscopes not provided).
  • Tuberculocidal: Three lots of Acecide High-Level Disinfectant and Sterilant were used. Tuberculocidal simulated-use testing was also performed on endoscopes (specific number of endoscopes not provided).
  • Virucidal, Fungicidal, Bactericidal: The text indicates general testing for these categories without specifying lot numbers or detailed sample sizes beyond "three lots" for sporicidal and tuberculocidal.
  • Clinical Testing (Residues): "Clinical testing of used endoscopes" was performed to determine residue levels (specific number of endoscopes not provided).
• Acecide Peracetic Acid Test Strips: Sample size for testing strip accuracy is not explicitly stated.
• Data Provenance: The document does not specify the country of origin for the data or whether the studies were retrospective or prospective. Given it's a 510(k) submission, it's generally expected that the studies were conducted prospectively to demonstrate compliance with regulatory requirements.

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

The document does not mention the use of experts to establish a "ground truth" in the way it might be applied to, for example, image interpretation by radiologists. Instead, the "ground truth" for the disinfectant and test strip efficacy is based on standardized microbiological testing methods (e.g., AOAC sporicidal testing) and chemical analysis. The qualifications of the personnel conducting these tests are not provided.

4. Adjudication method for the test set

Not applicable. The efficacy studies for a disinfectant and sterilant rely on direct measurements and adherence to established protocols, not on expert adjudication of ambiguous cases.

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 submission for a chemical disinfectant/sterilant and test strips, not an AI-powered diagnostic device that involves human reader interpretation.

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

• Standalone Performance: The described "efficacy testing" for the Acecide High-Level Disinfectant and Sterilant is essentially a standalone performance evaluation of the chemical agent itself under various conditions. The Acecide Peracetic Acid Test Strips also have a standalone performance in terms of their ability to accurately measure the chemical concentration. There is no "human-in-the-loop" aspect to these performance tests, as the devices are not diagnostic decision-support tools.

7. The type of ground truth used

• Acecide High-Level Disinfectant and Sterilant: The ground truth for efficacy is established by the ability to kill specific microorganisms (spores, mycobacteria, viruses, fungi, bacteria) and by adhering to established standards for these classifications (e.g., "sporicidal," "tuberculocidal," "virucidal," "fungicidal," "bactericidal"). For biocompatibility and material compatibility, the ground truth is established by chemical testing for residues, cytotoxicity, hemolysis, acute toxicity, and visual/physical inspection of materials after exposure.
• Acecide Peracetic Acid Test Strips: The ground truth for the test strips is their accuracy in measuring the concentration of peracetic acid, likely against a known standard or validated chemical assay.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a training set. The "training" for such products involves formulation development and process optimization, not algorithm training.

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

Not applicable, as there is no training set in the context of an AI/ML algorithm.

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