(185 days)
HANSON SCAR ADE is indicated for the topical management of keloid and hypertrophic scars
HANSON SCAR ADE is a topical gel made from silicones. HANSON SCAR ADE is intended for use in managing would and keloid scarring resulting from surgery, laser abrasion, chemical peels and other trauma. This product is offered non-sterile. For convenience it is packaged in half ounce and one ounce plastic tubes. Each tube will have Directions for Use, and Cautions. HANSON SCAR ADE is indicated for use to aid associated erythema or discoloration of scars. HANSON SCAR ADE is applied to the scar in a thin coat and excess is wiped away with a tissue. HANSON SCAR ADE is to be used on healed scars, in the case of surgery typically after 10 days from surgery. The product is not to be used on open wounds. Discontinue use if any infection is suspected, and obtain professional health care assistance.
I am sorry, but the provided text does not contain information on acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment for a device. The document is a 510(k) summary statement and a clearance letter for a medical device called "HANSON SCAR ADE," which is a silicone gel for scar management. It primarily focuses on the device's classification, intended use, and substantial equivalence to a predicate device (Kelo-Cote topical gel).
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the given information.
§ 878.4025 Silicone sheeting.
(a)
Identification. Silicone sheeting is intended for use in the management of closed hyperproliferative (hypertrophic and keloid) scars.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.