(55 days)
The Evanesce Scar Management System is intended for the over the counter topical management of Hypertrophic and Keloid Scars
The Evanesce Scar Management System is composed of a sheet of soft, flexible, translucent silicone elastomer.
The provided document is a 510(k) premarket notification for the Evanesce Scar Management System, a silicone elastomer sheeting intended for the topical management of hypertrophic and keloid scars. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed studies with acceptance criteria and performance data for the new device itself.
Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.
Here's why and what information is present:
- 510(k) Summary: The purpose of a 510(k) is to demonstrate that the new device is "substantially equivalent" to a legally marketed predicate device. This is primarily done through comparison of indications for use, technological characteristics, and safety and effectiveness information with the predicate.
- Predicate Device: The document identifies "SCAR HEAL" (510(k) K971468) from Specialty Systems, Inc. as the predicate device.
- Device Description and Intended Use: These are provided for the Evanesce Scar Management System, highlighting it as a sheet of soft, flexible, translucent silicone elastomer for over-the-counter topical treatment of hypertrophic and keloid scars.
- FDA Letter: The FDA's letter confirms their review and finding of "substantial equivalence" to devices marketed prior to May 28, 1976, allowing the device to be marketed. This letter signifies regulatory clearance, but it does not detail specific performance studies of the Evanesce system.
To answer your request, if this were a document that contained such information, it would typically look like this (hypothetical example, NOT from the provided text):
1. A table of acceptance criteria and the reported device performance
| Performance Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Scar Volume Reduction | ≥ 20% reduction in 8 weeks | 25.3% reduction (p |
§ 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.