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Rx: The coactiv+™ Antimicrobial Wound Gel is indicated for management of ulcers (including diabetic foot and leg ulcers and pressure ulcers), 1st and 2nd degree burns, partial & full thickness wounds, large surface area wounds and surgical incisions for adult populations.

OTC: The coactiv+™ Antimicrobial Wound Gel is indicated for management of minor lacerations, minor burns (1st degree burns) and abrasions for adult populations.

The coactiv+™ Antimicrobial Wound Gel is a white, odorless hydrogel that provides a moist wound environment conducive to wound healing. The coactiv+™ Antimicrobial Wound Gel provides preservative properties through an antimicrobial (PHMB) to help inhibit microbial colonization within the gel during shelf storage. Chronic wounds are known to contain non-viable tissue. The coactiv+™ Antimicrobial Wound Gel can facilitate debridement through a moist wound environment.

The coactiv+™ Antimicrobial Wound Gel contains water, Poloxamer 407, Glycerol, Trisodium citrate, PHMB (0.1% w/w), Citric acid, Disodium EDTA.

The coactiv+™ Antimicrobial Wound Gel dressing will be supplied in 0.7 oz. (21 g) white/opaque polypropylene (19 x 100 mm) screw cap tubes.

The device will be available as both a Rx and OTC product.

This document describes the FDA's 510(k) clearance for the coactiv+™ Antimicrobial Wound Gel. It explicitly states that the device is "substantially equivalent" to predicate devices and provides non-clinical and performance data to support this claim. However, it does not contain the kind of detailed information about acceptance criteria and study design (especially for an AI/ML medical device) that your request outlines.

Specifically, the document does not provide:

• A table of acceptance criteria for device performance beyond standard biocompatibility and stability testing.
• Information on a test set (sample size, data provenance) for an AI/ML device performance study.
• Details on expert involvement (number, qualifications, adjudication) for establishing ground truth related to AI/ML output.
• Any mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study or human reader improvement with AI.
• Any standalone (algorithm-only) performance data as would be relevant for an AI/ML device.
• The type of ground truth used relevant to AI/ML (e.g., expert consensus, pathology, outcome data).
• Details on a training set (sample size, ground truth establishment) for an AI/ML device.

The study described here is for a topical wound gel, not an AI/ML-driven device. The performance data presented relate to:

1. Biocompatibility Testing: According to ISO 10993 standards (e.g., cytotoxicity, sensitization, implantation, acute systemic toxicity, pyrogenicity, genotoxicity).
2. Performance Testing: USP <51> for preservative effectiveness, pH, viscosity, appearance, and microbial enumeration (TAMC/TYMC) for shelf-life and stability.
3. Animal Testing: A porcine model to demonstrate no negative impact on full thickness wound healing.

Therefore, I cannot fulfill your request for details on the acceptance criteria and study for an AI/ML device based on the provided text, as this document pertains to a physical wound gel.

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