(106 days)
Mepiform Adherent Silicone Dressing is intended for the management of both old and new hypertrophic and keloid scars. It can also be used as a prophylactic therapy on closed wounds which may prevent hypertrophic or keloid scarring.
The Mepiform Adherent Silicone Dressing for Scar Care consists of a silicone coated nonwoven bonded to an adhesive thermoplastic polyurethene film. The silicone dressing is protected by a low density polyethylene release film. The Mepiform dressing is individually sealed in a medical grade paper pouches and packaged in cartons of five (5) pouches each. The Mepiform dressings are available in two sizes: 5 cm x 7.5 cm (2" x 3") and 10 cm x 18 cm (4" x 7").
The provided text describes a 510(k) summary for a medical device called Mepiform Adherent Silicone Dressing for Scar Care. It outlines the device's purpose, components, and regulatory classification. However, the document does not contain any information about a study proving the device meets acceptance criteria.
The 510(k) summary focuses on establishing substantial equivalence to a predicate device based on its intended use, technological characteristics, and safety profile (nontoxic, nonirritant, nonsensitizing in laboratory tests). It does not present results from a clinical trial or performance study that would typically include acceptance criteria and reported device performance metrics.
Therefore, I cannot provide the requested table or answer the specific questions about sample sizes, ground truth, expert involvement, or comparative effectiveness studies, as this information is not present in the provided text.
The information given is primarily for regulatory clearance based on substantial equivalence, not a detailed performance study.
§ 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.