(129 days)
[The device] is indicated for managing signs and symptoms of nail dystrophy, i.e., nail splitting and nail fragility, for intact or damaged nails. [The device] coats and adheres to the nail surface preventing direct abrasion and friction on the nail surface while also providing protection against the effects of moisture.
This product for nail dystrophy is a biocompatible, polymeric lacquer that is applied directly to the nail. The product is dispersed in a solution that dries rapidly, adhering to the contours of the nail to form a transparent, colorless, flexible, waterproof barrier.
The provided text is related to a 510(k) summary for a "Liquid Bandage" device intended for nail dystrophy. However, the document does not describe acceptance criteria for software, an AI-powered device, or a study that uses a test set, ground truth, experts, or comparative effectiveness studies.
The document outlines the regulatory submission for a medical device (liquid bandage for nail dystrophy), comparing it to a predicate device (Ecocel®). It discusses general biocompatibility testing, preclinical studies, laboratory studies, and clinical safety studies to demonstrate substantial equivalence to the predicate.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study proving the device meets those criteria, as the necessary information regarding software performance, AI, test sets, ground truth establishment, expert involvement, or comparative effectiveness with human readers is not present in the provided text.
The text mentions "clinical studies" for safety but gives no details about their design, sample size, or specific outcomes in relation to predefined performance acceptance criteria for a diagnostic or AI device.
§ 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.