(176 days)
The Nixall Antimicrobial Solutions™ Skin & Wound Hydrogel is intended to be used for Over-The-Counter and Prescription Use. The Over-The-Counter use is intended for the following indications:
- For use on minor skin irritations, minor cuts, exit sites, minor lacerations, minor abrasions and minor burns, including sunburns.
- To moisten and lubricate absorbent wound dressings and moisten the wound bed. A moist wound and skin environment facilitates autolytic debridement.
The Prescription Use Nixall Antimicrobial Solutions™ Skin & Wound Hydrogel is indicated for the following uses:
- Use with dermal irritation, sores, injuries and ulcers of dermal tissues.
- Moistening and lubricating absorbent wound dressings and the wound bed and facilitate autolytic debridement of acute and chronic dermal lesions.
- Management of partial or full thickness wounds such as 1st and 2nd degree burns, stage I – IV pressure ulcers, diabetic and stasis ulcers, abrasions and skin irritations, surgical wounds (donor and graft sites, incisions), trauma wounds, and various dermatoses including atopic dermatitis.
The Nixall Antimicrobial Solutions™ Skin & Wound Hydrogel is a hypochlorous acid hydrogel solution applied topically to skin and wound areas.
The hydrogel dressing is supplied in various packaging configurations. The OTC hydrogel and the prescription use hydrogel contain hypochlorous acid, a known antimicrobial, which serves as a preservative to inhibit the growth of microorganisms in the hydrogel during shelf-life. The OTC and RX products are supplied non-sterile.
It appears there might be a misunderstanding of the provided FDA 510(k) clearance letter. The document for "Nixall Antimicrobial Solutions™ Skin & Wound Hydrogel" pertains to a medical device (a topical hydrogel), specifically a wound care product, and not an AI/software as a medical device (SaMD).
Therefore, the concepts of acceptance criteria for an AI model, training sets, test sets, ground truth establishment by experts, MRMC studies, or standalone algorithm performance are not applicable to this type of medical device clearance. The "study that proves the device meets the acceptance criteria" in this context refers to standard non-clinical testing for medical devices.
The FDA 510(k) summary provided details on standard medical device testing, which includes:
- Biocompatibility Testing (ISO 10993 series): To ensure the device is safe for contact with the human body (e.g., cytotoxicity, irritation, sensitization, local effects after implantation, chemical characterization).
- Antimicrobial Effectiveness Testing (USP ): To demonstrate the product's ability to inhibit microbial growth within the container (as it contains hypochlorous acid as a preservative).
- Bacterial Endotoxins Test (USP ): To ensure levels of endotoxins are safe.
Therefore, I cannot fulfill the request as stated because the provided input does not describe an AI/software device and thus does not contain the information requested about AI model acceptance criteria and validation.
If you have a document describing an AI/SaMD product, I would be happy to analyze it according to your requested criteria.
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