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For the cleansing of dermal lesions such as stage I-IV pressure uicers, stasis الداريع s, diabetic ulcers, foot ulcers, post-surgical wounds, first and second degree burns, cuts, abrasions and minor irritation of the skin.

The Allclenz " Wound Cleanser is a colorless, transparent solution supplied nonsterile in 12 fl. oz. plastic bottles equipped with trigger-spray intended for cleansing and irrigation of dermal wounds.

Biocompatibility of the product has been established by primary dermal irritation (rabbit), ocular irritation (rabbit), sensitization (guinea pig), and in vitro cytotoxicity studies.

The provided text is a 510(k) summary for a medical device (wound cleanser) and does not contain information related to a study that proves the device meets acceptance criteria as typically found for AI/ML-based medical devices or diagnostic tools.

The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device based on composition, function, and intended use, along with basic biocompatibility studies. It does not involve performance metrics like sensitivity, specificity, accuracy, or expert adjudication as would be relevant for the questions asked.

Therefore, I cannot provide the requested information, as these details are not present in the provided document.

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