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Over-the-Counter Use: For management of minor skin abrasions, minor irritations, minor cuts, minor cuts, minor burns and intact skin. Prescription Use: For management of wounds such as Stage I-IV pressure ulcers, partial and full thickness wounds, diabetic foot and leg ulcers, post-surgical wounds, first-and second-degree burns, grafted and donor sites, and minor irritations of the skin in addition to moistening and lubricating absorbent wound dressings.

CleanSmart™ Wound Cleanser is a clear hypotonic solution topically applied to skin and wound areas. The subject device is a wound management and cleansing solution that is intended for cleansing, irrigating, and debriding dermal wounds in addition to moistening and lubricating absorbent wound dressings (e.g. gauze). 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. CleanSmart™ Wound Cleanser contains the following ingredients: Ionized water (99.927%), Sodium chloride (0.06%), Hypochlorous acid (0.011%) and hypochlorite Ion (0.002%). CleanSmart™ Wound Cleanser will be supplied in Polyethylene terephthalate (PET) bottles of various volumes (2 oz, 8 oz, 16 oz, 23 oz) with spray inserts / caps.

This document is a 510(k) Summary for the CleanSmart™ Wound Cleanser, indicating that it is a medical device application seeking to demonstrate substantial equivalence to previously cleared devices. It is not an AI/ML device, and therefore the majority of the requested information (sample sizes, expert ground truth, MRMC studies, standalone performance, training sets, etc.) is not applicable.

However, I can extract the relevant information regarding the performance testing and acceptance criteria as described in the document.

1. Table of Acceptance Criteria and Reported Device Performance:

Study Proving Device Meets Acceptance Criteria:

The study that proves the device meets the acceptance criteria is detailed in the "Performance Testing" section (Page 5, Section 14) of the 510(k) Summary.

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

• Sample Size for Test Set: This type of information is not provided in the summary. For studies like biocompatibility (ISO 10993) and preservative effectiveness (USP ), the sample sizes are determined by the specific standards and test methodologies themselves, rather than being explicitly stated as a general "test set" size in this summary.
• Data Provenance: Not explicitly stated, but these are laboratory tests following established international standards (ISO) and pharmacopeial monographs (USP). The manufacturer is Simple Science, LLC, based in Edina, Minnesota, USA, suggesting the studies were likely conducted in the US or by accredited labs following these standards. The data would be prospective, as these are de novo tests conducted for the purpose of the 510(k) submission.

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

This information is not applicable to the type of device and testing described. The "ground truth" for chemical and biological laboratory tests of a wound cleanser is based on the objective readings and protocols of the specified standards (ISO 10993, USP ), not on human expert consensus, pathology, or outcomes data in the way an AI/ML diagnostic device would require.

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

Not applicable. Adjudication methods are typically relevant for subjective expert reviews, particularly in medical image analysis or clinical trials involving human assessment, which is not the case for these laboratory-based performance tests.

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 device is a wound cleanser, not an AI/ML diagnostic or assistive device that would involve human readers.

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

Not applicable. This device is a physical product (wound cleanser), not an algorithm. Therefore, "standalone performance" in the context of an algorithm is irrelevant.

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

The "ground truth" for the performance tests described (biocompatibility, preservative effectiveness, stability) is based on:

• Objective measurements and standardized protocols: For ISO 10993 (biocompatibility), the ground truth is determined by the cellular responses and tissue reactions measured against established safety thresholds.
• Microbiological assay results: For USP (preservative effectiveness), the ground truth is the measured reduction in microbial populations over time, compared to acceptance criteria defined in the USP monograph.
• Chemical and physical stability parameters: For shelf-life stability, the ground truth is the chemical composition and physical properties remaining within specified ranges over time.

These are not based on expert consensus, pathology, or outcomes data in a clinical sense.

8. The sample size for the training set:

Not applicable. This is not an AI/ML device, so there is no "training set."

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

Not applicable. As there is no training set for an AI/ML algorithm, this question is not relevant.

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