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Dermacyn™ Wound Care is intended for moistening absorbent wound dressings and for debriding and cleaning acute and chronic dermal lesions, such as Stage I-IV pressure ulcers, statis ulcers, diabetic ulcers, post-surgical wounds, first and second degree burns, abrasions and minor irritations of the skin.

Dermacyn™ is intended for moistening absorbent wound dressings and cleaning minor cuts, minor burns, superficial abrasions and minor irritations of the skin.

The subject device is a wound cleansing solution that is intended for the moistening and debriding of dermal wounds. 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. The subject device is offered in various bottle sizes with and without a trigger spray.

This premarket notification (K060113) for Dermacyn™ Wound Care does not contain the detailed information necessary to complete most of the requested sections regarding acceptance criteria and study data. The document focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance, rather than presenting a performance study with acceptance criteria.

However, based on the provided text, I can infer the acceptance criteria relate to the device being substantially equivalent to the predicate devices (Allclenz™ Cleanser and CarraKlenz Wound Cleanser) in terms of function, intended use, and safety, as demonstrated through non-clinical testing.

Here's a breakdown of what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance

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

• Not provided. The document states "Non-clinical testing was conducted" but gives no details about sample sizes, study design (retrospective/prospective), or data provenance.

3. 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)

• Not applicable / Not provided. This device is a wound cleanser, and the "testing" mentioned is non-clinical, likely bench testing for safety and performance (e.g., microbial efficacy, chemical composition, biocompatibility). It does not appear to involve human interpretation or a "ground truth" established by clinical experts in the way AI/diagnostic devices would.

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

• Not applicable / Not provided. See point 3.

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. This is not an AI or diagnostic device, so an MRMC study is not relevant or mentioned.

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

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

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

• Not applicable / Not provided. For non-clinical testing of a wound cleanser, "ground truth" would relate to accepted standards for biocompatibility (e.g., ISO standards), chemical composition validation, or efficacy against specific microorganisms in a lab setting, rather than clinical outcomes or diagnostic accuracy. The document doesn't detail these specific ground truths.

8. The sample size for the training set

• Not applicable / Not provided. This is not a machine learning device, so there is no training set in the conventional sense.

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

• Not applicable / Not provided. See point 8.

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