Search Results

Rx Indications for Use: PluroGel® Antimicrobial Burn and Wound Dressing is indicated for the management of full and partial thickness wounds including surgically created wounds, dermal ulcers (pressure ulcers), leg ulcers (diabetic foot ulcers), superficial wounds, first degree burns, partial thickness burns, and donor sites. PluroGel® Antimicrobial Burn and Wound Dressing maintains a moist wound and skin environment that supports autolytic debridement of necrotic tissue.

OTC Indications for Use: PluroGel® Burn and Wound Dressing (OTC) is indicated for the management of minor cuts, minor burns, and minor lacerations. PluroGel® Burn and Wound Dressing (OTC) maintains a moist wound and skin environment.

PluroGel® Antimicrobial Burn and Wound Dressing and PluroGel® Burn and Wound Dressing (OTC) is a translucent, biocompatible, odorless, semisolid gel intended to provide and maintain a clean and moist wound environment that is conducive to healing. The dressing maintains moisture in the wound and protects the wound from desiccation to provide an optimal moist wound environment conducive to wound healing. PluroGel® Antimicrobial Burn and Wound Dressing and PluroGel® Burn and Wound Dressing (OTC) is non-cytotoxic, contains a surfactant, and is water soluble to aid in the removal of wound debris in between dressing changes.

PluroGel® is provided non-sterile and contains phenoxyethanol and potassium sorbate as antimicrobial preservative agents to inhibit the growth of microorganisms within the product during shelf storage before and after opening.

I am sorry, but the provided text does not contain the information required to answer your request regarding the acceptance criteria and the study that proves the device meets the acceptance criteria for a medical device that uses AI. The document discusses a 510(k) premarket notification for "PluroGel® Antimicrobial Burn and Wound Dressing" and "PluroGel® Burn and Wound Dressing (OTC)," which are wound dressings and not AI-powered devices.

Therefore, I cannot extract details about:

• A table of acceptance criteria and reported device performance for an AI device.
• Sample sizes for test sets, data provenance, or details about training sets for an AI model.
• Number of experts, their qualifications, or adjudication methods for ground truth establishment in an AI context.
• MRMC studies, effect sizes for human readers with AI assistance, or standalone algorithm performance.
• The type of ground truth (expert consensus, pathology, outcomes data) relevant to AI.

The document primarily focuses on the substantial equivalence of the wound dressing product to a predicate device based on its intended use, technological characteristics (ingredients, form, sterility), and non-clinical testing (biocompatibility, shelf life, period of use after opening, and a single animal wound healing study). It explicitly states "Summary of Clinical Testing: Not applicable," which further confirms no human clinical trials (nor AI performance studies) were conducted for this submission.

Ask a specific question about this device