(184 days)
Acticoat™ silver coated dressing is intended for use as an effective barrier to bacterial penetration and as a method to reduce infection of partial and full thickness wounds.
Acticoat™ silver coated dressing is a 3-ply gauze wound dressing consisting of an absorbent rayon/polyester core and an upper and lower layer of silver coated high density polyethylene mesh designed to be a barrier against microbial infections of a wound. The silver in the coating is an alloy of silver and oxygen. The coating is highly porous, and the film has enhanced solubility in water-based fluids. Additionally, the performance characteristics of the Acticoat™ silver coated dressing are similar to those found in untreated gauze-based dressings in the areas of absorptivity and moisture content, abrasion resistance and adhesion, and tensile strength.
I am sorry, but I cannot provide an answer based on the context you provided. The provided text is a 510(k) summary for a medical device (a silver-coated wound dressing) and discusses substantial equivalence to a predicate device, as well as various performance tests like silver dissolution, absorptivity, tensile strength, and antimicrobial activity. However, it does not contain the specific information required to answer your questions about acceptance criteria, a study that proves the device meets them, sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set details, or how ground truth was established for a training set. This type of information is typically associated with the evaluation of artificial intelligence/machine learning (AI/ML) driven medical devices, which is not what this document describes.
§ 880.5090 Liquid bandage.
(a)
Identification. A liquid bandage is a sterile device that is a liquid, semiliquid, or powder and liquid combination used to cover an opening in the skin or as a dressing for burns. The device is also used as a topical skin protectant.(b)
Classification. Class I (general controls). When used only as a skin protectant, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.