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Sterilox™ is a high level disinfectant system intended for processing heat sensitive medical devices when used according to the User Manual with an immersion time of ten (10) minutes at 30°C. Sterilox is a single use product generated on site by the Maxigen II (E200) generator for use at its MRC of 400-450 ppm (AFC). The Sterilox high level disinfectant is intended for processing only in an automated endoscope reprocessor or washer disinfector with FDA-cleared capability to maintain the solution temperature at 30°C.

The device is intended for use by qualified health care personnel trained in its use.

The Sterilox Liquid Chemical High Level Disinfectant System is an apparatus that produces a single use High Level Disinfectant by on-site electrochemical activation (electrolysis) of a dilute aqueous solution of sodium chloride (NaCl). The disinfectant is then circulated on the internal and external surfaces of re-usable heat-sensitive medical devices within a washer-disinfector AER with FDA-cleared capability to maintain the solution temperature at 30°C used in hospitals, clinics and various other health care settings. It is a device intended for use by qualified healthcare personnel trained in its use.

Here's an analysis of the provided text regarding the Sterilox™ High Level Disinfectant System, structured to answer your specific questions:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the specific numerical sample sizes for each microbiological or toxicity test test set, other than:

• "Clinical In-Use": "No surviving microorganisms on any of the endoscopes tested" implies a sample size of multiple endoscopes, but the exact number isn't given.
• "Simulated Use Test": "inoculated scopes were processed in Sterilox and AER for 10 minutes at 30° C." implies multiple scopes, but quantity not specified.
• General Microbiological Tests (AOAC, EPA methods): These methods typically have defined sample sizes, but the report summarizes the results rather than detailing the experimental setup for each test performed on this specific device.

Data Provenance: The information provided generally describes laboratory testing (e.g., AOAC methods for efficacy, animal studies for toxicity). There is no explicit mention of data origin (e.g., country) for these studies. The "Clinical In-Use" implies real-world usage, making it prospective in nature for that specific part of the study. The remaining tests are laboratory studies.

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

There is no information in the provided text about the use of "experts" to establish ground truth in the way one might for diagnostic AI. The ground truth for the microbiological efficacy tests and toxicological tests is established by standardized laboratory methods (e.g., AOAC, EPA protocols) which inherently define what constitutes a positive or negative result. For instance, for sporicidal activity, the ground truth is whether spores are killed as per the method's criteria, not an expert's interpretation of an image.

4. Adjudication Method for the Test Set

Not applicable. This device is a high-level disinfectant, not an AI or diagnostic tool where expert adjudication of results would typically be employed. The tests are laboratory-based and use objective endpoints.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. This is a chemical disinfectant, not a diagnostic imaging device or AI algorithm for human interpretation enhancement. Therefore, an MRMC study is not relevant or included in this submission.

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

Yes, in the sense that all efficacy and safety studies were conducted on the device itself (the Sterilox Liquid Chemical High Level Disinfectant System and its germicide solution), demonstrating its performance independently without a human interpretation component that would require "human-in-the-loop" considerations.

7. The Type of Ground Truth Used

The ground truth used for this device's evaluation is primarily:

• Laboratory outcomes/direct measurements: For microbiological efficacy, it's the destruction or inactivation of specific microorganisms (e.g., spores, bacteria, fungi, viruses, mycobacteria) under specified conditions, measured by standard laboratory culture techniques.
• Physiological/toxicological responses: For toxicity, the ground truth is the observable response (or lack thereof) in animal models (e.g., irritation, sensitization, LD50 values, mutagenicity) against established biological endpoints.
• Chemical analysis: For residue data, the ground truth is the quantifiable level of Sterilox components remaining after rinsing.
• Physical observation: For material compatibility, the ground truth is visible changes, damage, or corrosion.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device. There is no "training set" in the context of supervised learning. The testing described is empirical validation against pre-defined performance standards.

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

Not applicable, as there is no training set for this type of device submission.

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Sterilox is a high level disinfectant system intended for processing heat-sensitive medical devices when used according to the User Manual with an immersion time of ten (10) minutes at 25°C. Sterilox is a single use product generated on site for use at its MRC of 650-675 ppm (AFC). Sterilox is intended for use with manual or automatic endoscope reprocessing protocols.

Sterilox High Level Disinfectant system is intended for use by qualified health care personnel trained in its use.

The Sterilox Liquid Chemical High Level Disinfectant System is an apparatus that produces a single use High Level Disinfectant by on-site electrochemical activation (electrolysis) of a dilute aqueous solution of sodium chloride (NaCI). The germicide is then circulated through and about reusable heat-sensitive medical devices either in a manual system or within a typical washer-disinfector used in hospitals, clinics and various other health care settings. It is a device intended for use by qualified healthcare personnel trained in its use.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided 510(k) Summary.

Acceptance Criteria and Device Performance for Sterilox Liquid Chemical High Level Disinfectant System

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the efficacy tests performed and the results reported as "Meets (efficacy) requirements" or "Solution is..." (e.g., fungicidal, bactericidal, virucidal, tuberculocidal). For "High Level Disinfectant", the primary criteria relate to the destruction of specific microorganisms within a defined time and temperature.

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

The document does not explicitly state a single comprehensive "test set" sample size in terms of the number of unique devices or the overall quantity of tests performed for all criteria. Instead, it lists various studies, each with its own sample considerations, but the exact number of replicates or individual samples within each test is not provided in this summary.

Data Provenance: The document does not specify the country of origin for the data. The studies are described as lab-based efficacy tests (e.g., AOAC methods) and simulated-use/clinical in-use tests. It can be inferred that these are prospective studies conducted specifically for this 510(k) submission, rather than retrospective analyses of pre-existing data.

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

This information is not provided in the 510(k) summary. For microbiological efficacy studies, the "ground truth" is typically established by the laboratory performing the tests and adhering to standardized methodologies (e.g., AOAC, EPA). The interpretation of results against pass/fail criteria is inherent in these methods. There's no mention of a separate panel of experts establishing ground truth for individual test outcomes beyond the standard practices of the testing labs.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method in the context of multiple readers or reviewers for the test results. The efficacy tests are primarily quantitative (e.g., log reduction, survival/non-survival) and are typically evaluated against pre-defined acceptance criteria specified by the test method (e.g., AOAC, EPA guidelines).

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study (MRMC for human readers improving with AI) is relevant for diagnostic imaging AI devices where human interpretation is assisted by AI. The Sterilox Liquid Chemical High Level Disinfectant System is a physical disinfectant system, not a diagnostic AI tool, so an MRMC study is not applicable.

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

Yes, the primary efficacy testing represents "standalone" performance in the sense that the disinfectant solution's performance was evaluated inherently. While a human initiates the process and follows instructions, the efficacy (microbial kill, toxicological safety, etc.) is an intrinsic property of the chemical system itself when used as directed, independent of ongoing human-in-the-loop decisions during its operation for a specific disinfection cycle. The "Microbiological Efficacy" and "Residue Data" sections specifically detail these standalone performance evaluations.

7. The Type of Ground Truth Used

The ground truth used for the efficacy studies can be categorized as follows:

• Microbiological Culture Results: For all microbial efficacy tests (sporicidal, fungicidal, bactericidal, virucidal, tuberculocidal, simulated use, clinical in-use), the "ground truth" is determined by established laboratory methods that quantify or qualitatively assess the survival or death of target microorganisms. This involves culturing residual organisms after exposure to the disinfectant.
• Analytical Chemistry/Toxicology Assays: For residue data and toxicological assessments, the "ground truth" is derived from quantitative analytical tests for chemical residues and standardized biocompatibility/toxicology assays (e.g., skin irritation, mutation assays).

8. The Sample Size for the Training Set

This device does not utilize a "training set" in the context of machine learning or AI. Therefore, this question is not applicable. The development of chemical disinfectants relies on chemical formulation, microbiology, and toxicology, not statistical models trained on data.

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

As there is no "training set" for this type of device, the concept of establishing ground truth for it is not applicable.

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