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Vashe™ Wound Cleanser is intended for cleansing, irrigating, moistening, and debriding acute and chronic dermal lesions, such as Stage I-IV pressure ulcers, stasis ulcers, diabetic ulcers, post-surgical wounds, first and second degree burns, abrasions and minor irritations of the skin in addition to moistening and lubricating absorbent wound dressings. The Vashe™ Wound Cleanser is intended for use by qualified health care personnel trained in its use.

The subject device is a wound cleansing solution that is intended for cleansing, irrigating, and debriding dermal wounds in addition to moistening and lubricating absorbent wound dressings. The mechanical action of fluid moving across the wound provides for the mechanism of action and aids in the removal of foreign objects such as dirt and debris. Vashe is offered in various volumes.

The provided text is a 510(k) summary for the Vashe™ Wound Cleanser and associated FDA correspondence. This device is a wound cleansing solution, and the documentation focuses on demonstrating its substantial equivalence to existing, legally marketed predicate devices, rather than presenting a performance study with specific acceptance criteria and detailed study results as one might find for a novel diagnostic or therapeutic device.

Therefore, many of the requested categories for acceptance criteria and study details are not directly applicable or explicitly stated in this type of submission.

Here's an attempt to extract and interpret the information based on the provided text, noting where specific details are absent:

1. Table of Acceptance Criteria and Reported Device Performance

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

• The document describes pre-clinical testing for biocompatibility, but does not specify a "test set" in the context of clinical performance data or algorithm validation.
• Sample Size: Not specified. Pre-clinical testing often involves in-vitro or animal studies, but no numbers are provided here.
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). While "pre-clinical" implies lab or animal studies, the specific details are absent.

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

• This is not applicable to this type of submission. There is no mention of a "test set" requiring expert-established ground truth in the context of diagnostic performance. The evaluation is based on substantial equivalence to existing products.

4. Adjudication Method for the Test Set

• Not applicable. No "test set" and corresponding adjudication methods are mentioned for evaluating device performance in the provided text.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Improvement with AI vs. Without AI Assistance

• Not applicable. This device is a wound cleanser, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study is outside the scope of this submission.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Not applicable. This device is a physical wound cleanser, not an algorithm.

7. The Type of Ground Truth Used

• For the biocompatibility testing, the "ground truth" would be established by standard biological assays and observation for adverse reactions, comparing results against established safety thresholds for medical devices.
• For the overall device, the "ground truth" for substantial equivalence is derived from a comparison of its characteristics (indications, technology, performance, safety) to those of the legally marketed predicate devices. The predicates themselves are considered "proven" safe and effective through prior FDA clearance.

8. The Sample Size for the Training Set

• Not applicable. This device is a physical product, not an AI model requiring a training set.

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

• Not applicable. As above, this is not an AI model.

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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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