(71 days)
Silimed Tissue Expanders are intended for temporary subcutaneous implantation to develop surgical flaps and additional tissue coverage required in a wide variety of applications, particularly to aid in reconstruction following mastectomy, to aid in the treatment of underdeveloped breasts, and to aid in the treatment of soft tissue deformities.
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I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, specifics of a study, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details. This document is a 510(k) clearance letter from the FDA for a device called "Silimed Tissue Expander," outlining its regulatory status and intended use. It does not contain the detailed study information required to answer your request.
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