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REVERA™ Wound Care is indicated for 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 for traumatic wounds, cuts, abrasions, and minor burns.

REVERA™ Wound Care, is a single use saline topical wound wash, that will be supplied in a 60 ml (2 oz) pouch. The mechanical action of the solution moving across the wound aids in the removal of foreign objects e.g. dirt and debris. No preservatives or stabilizers are added. REVERA™ Wound Care passes the USP sterility test.

This is a 510(k) premarket notification for a medical device (REVERA™ Wound Care), which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with acceptance criteria in the way an AI/software as a medical device (SaMD) submission would.

Therefore, the provided text does not contain the information requested regarding acceptance criteria and a study proving device performance in the context of an AI/ML or SaMD device.

Here's a breakdown of why the requested information cannot be extracted from this document:

• Type of Device: REVERA™ Wound Care is a "saline topical wound wash." It is a physical product, not a software or AI device.
• Regulatory Pathway: A 510(k) submission for a physical device primarily aims to show "substantial equivalence" to a legally marketed predicate device. This involves comparing technological characteristics and intended use, not typically a detailed performance study against specific acceptance criteria for diagnostic or prognostic accuracy.
• Lack of AI/ML Specifics: There is no mention of algorithms, computational models, or any form of AI or machine learning in the text.

If this were an AI/SaMD 510(k) submission, the information requested would typically be found in sections detailing performance studies, clinical validation, or analytical validation.

In summary, none of the requested information (acceptance criteria table, sample size, data provenance, ground truth experts, adjudication, MRMC, standalone performance, ground truth type, training set size, or training set ground truth establishment) is present because this document is for a physical wound care product, not an AI/SaMD device.

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