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Coreleader Scar-D Silicone Sheeting is intended for use: for the management of closed hypertrophic and keloid scars.

Coreleader Scar-D silicone sheeting is a thin, soft and self-adhesive sheet made from medical grade silicone with a PU Foam/PU non-woven film backing paper and a non-silicone polyester release paper. It is able to hold moisture with adequate pressure on the scar. The sheets are rectangular and come in four sizes, 5 cm x 8 cm, 5 cm x 20 cm, 2.5 cm x 100 cm and 5 cm x 100 cm. They are approximately 0.6 mm thick. The sheet maybe cut or trimmed to the desired shape or size prior to placement on the scar. The sheets are not for use on an open wound, are not sterile but can be washed.

The provided text is a 510(k) summary for the "Coreleader Scar-D Silicone Sheeting." This document focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance, rather than presenting a performance study with acceptance criteria.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set details cannot be extracted from this document.

The document primarily describes the device's characteristics, intended use, and states that it is substantially equivalent to two predicate devices (BIODERMIS CORP., K003948, EPI-DERM SILICONE GEL SHEETING and SMITH & NEPHEW UNITED, INC., K935803, CICA-CARE SILICONE GEL SHEET). It does not contain information about a specific study designed to prove the device meets pre-defined acceptance criteria for its performance.

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