(31 days)
Silicone 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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The provided text is a U.S. FDA 510(k) clearance letter for a "Magnetic Port Silicone Tissue Expander." This document primarily deals with regulatory clearance based on substantial equivalence to a predicate device and does not contain information about acceptance criteria or a study proving device performance against such criteria.
Therefore, I cannot fulfill your request for the detailed information about acceptance criteria and a study from the provided text. The document is about regulatory approval, not a performance study report.
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