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ACECIDE-C is a high level disinfectant intended to disinfect reusable clean heatsensitive semi-critical medical devices (such as flexible endoscopes) which contact mucous membranes when used at or above its minimum recommended concentration of 2000 ppm peracetic acid for 7.0 minutes at 20°C.

ACECIDE-C is a sterilant intended to sterilize reusable clean heat-sensitive critical and semi-critical medical devices (such as flexible endoscopes) which contact and potentially penetrate into sterile body areas, for which there is no other practical method of sterilization, when used at or above its minimum recommended concentration of 2000 ppm peracetic acid for 2.0 hours at 20℃.

ACECIDE Test Strips are used with ACECIDE-C High Level Disinfectant and Sterilant use solution to ensure that the level of peracetic acid is above the minimum recommended concentration of 2000 ppm.

ACECIDE-C High-Level Disinfectant and Sterilant is packaged in two separate plastic bottles: ACECIDE-C 6.8% Peracetic Acid Concentrate Solution 1 is a concentrate of acetic acid and hydrogen peroxide, which react with each other in the presence of a catalyst and stabilizer to form 6.2 - 6.8 % w/w peracetic acid at a pH value of <1. ACECIDE-C Buffer Concentrate Solution 2 contains a sequestrant, an anti-corrosive, and buffer salts for a pH value of about 8.7 to 9.7. At the time of use, one part of ACECIDE-C 6.8% Peracetic Acid Concentrate Solution 1 and one part of the ACECIDE-C Buffer Concentrate Solution 2 is mixed with 18 parts of tap water at 20℃ for a final concentration of 3100 - 3400 ppm peracetic acid.

ACECIDE Test Strips are used with ACECIDE-C use solution to ensure that the level of peracetic acid is above the minimum recommended concentration of 2000 ppm. The test strips are based on the same basic chemistry as other peracetic acid test strips and assay methods. Peracetic acid oxidizes iodide to iodine with starch forming a visible blue-gray/blue-black compound with iodine. This color change in the indicator paper is the visual basis for the tests strips and their reading.

The document describes the acceptance criteria and supporting studies for ACECIDE-C High-Level Disinfectant and Sterilant, which is a liquid chemical high-level disinfectant and sterilant.

Acceptance Criteria and Reported Device Performance

Study Information

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

   • AOAC Use Dilution Test: Stainless steel penicylinders labeled with Staphylococcus aureus, Salmonella choleraesuis, and Pseudomonas aeruginosa. The exact number of cylinders per test is not specified, but the methodology refers to AOAC standards (955.14, 955.15, and 964.02) which dictate specific sample sizes (e.g., 60 carriers per organism per concentration).
   • AOAC Fungicidal Test: Cultures of Trichophyton mentagrophytes, Aspergillus niger, and Candida albicans. Again, the exact number of replicates is not specified but would follow AOAC 955.17 standards.
   • Virucidal Tests: Influenza A Virus, Herpes Simplex Virus type 1, Adenovirus type 2, and Poliovirus type 1. Sample sizes for viral inactivation studies typically involve multiple replicates, but specific numbers are not given.
   • Mycobactericidal Tests: M. terrae. Not specified.
   • Sporicidal Exposure Time Determination: 40 of each type of spore-labeled carrier (B. subtilis and C. sporogenes).
   • Full Three Lot AOAC Sporicidal Test: Three lots of ACECIDE-C were tested, implying multiple carriers per lot, as per AOAC 966.04.
   • Confirmatory Sporicidal Test: One lot of ACECIDE-C.
   • Simulated-use tests with flexible endoscopes (M. terrae): Not specified the number of endoscopes or replicates. Endoscopes used included a bronchoscope, gastroscope, and colonoscope.
   • Simulated-use tests with flexible endoscopes (B. subtilis): Not specified the number of endoscopes or replicates. Endoscopes used included a bronchoscope, gastroscope, and colonoscope.
   • In-use tests with ACECIDE-C: Olympus gastroscopes and colonoscopes (number not specified but implied to be multiple from an endoscopy clinic), and Olympus bronchoscopes (number not specified but implied to be multiple from a hospital).
   • Data Provenance: The studies were conducted by MicroChem Laboratory, Inc. in Euless (Dallas), TX, USA. The studies are retrospective from the perspective of the 510(k) submission, confirming product performance.

2. 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 device is a chemical disinfectant/sterilant, not an imaging or diagnostic device requiring human expert interpretation for ground truth. The "ground truth" is established through standardized microbiological and chemical assays, such as those defined by AOAC and EPA guidelines, which measure microbial kill or chemical concentration. The document mentions Norman Miner, Ph.D., President/Study Director of MicroChem Laboratory, Inc., as the application correspondent and likely oversaw these studies. His qualifications suggest expertise in microbiology and chemistry relevant to disinfectant testing.

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

   • Not applicable. The ground truth relies on objective laboratory assays to determine microbial viability (or lack thereof) post-exposure and chemical concentration, not subjective human assessment requiring 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 an AI-based diagnostic or imaging device.

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

   • The "standalone" performance here refers to the disinfectant's ability to kill microbes and spores without human intervention during the disinfection/sterilization process itself (beyond preparing the solution and operating the device or immersing instruments). All the studies (AOAC, virucidal, mycobactericidal, sporicidal, simulated-use, and in-use tests) demonstrate the standalone efficacy of the ACECIDE-C solution itself under specified conditions.

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

   • The ground truth is based on microbiological viability testing (showing no colony formation, no viral infectivity, no fungal growth) and chemical concentration measurements. For example, the AOAC Sporicidal Test directly verifies sterilization by determining the absence of viable spores post-treatment. The "in-use" tests directly cultured endoscopes from patient use to confirm the absence of bacteria.

7. The sample size for the training set:

   • Not applicable. This is not a machine learning or AI device that requires a "training set." The studies performed are direct efficacy tests of a chemical product.

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

   • Not applicable for the same reason as above.

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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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