(56 days)
For Over-The-Counter use SignaDRESS™ DuoDERM® Dressing may be used on abrasions, minor cuts, minor scalds and burns, and skin tears. Under the supervision of a health care professional, SignaDRESS may be used for wounds such as leg ulcers ( venous stasis ulcers, arterial ulcers and leg ulcers of mixed aetiology), pressure ulcers (Stage I-IV) and diabetic ulcers, surgical wounds (postoperative wounds, donor sites, dermatological excisions), and burns (first and second degree).
SignaDRESS™ DuoDERM® Dressing is a sterile hydrocolloid dressing that, over-the-counter, may be used on abrasions, lacerations, minor cuts, minor scalds and burns and skin tears. Under the supervision of a healthcare professional, SignaDRESS may be used for wounds such as leg ulcers (venous stasis ulcers, aertial ulcers and leg ulcers of mixed aetiology), pressure ulcers (Stage I-IV) and diabetic ulcers, surgical wounds (post-operative wounds, donor sites, dermatological excisions), and burns (first and second degree).
This document is a 510(k) Premarket Notification for the SignaDRESS™ DuoDERM® Dressing. It establishes the device's substantial equivalence to a predicate device but does not contain a study detailing acceptance criteria and device performance. Instead, it focuses on regulatory approval based on equivalence and safety data from a previous submission.
Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth details for a study, as this document does not describe such a study.
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