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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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I am sorry, but based on the provided document, I cannot extract the information required to answer your request. The document is a 510(k) clearance letter from the FDA for a device called "Rollicone Tissue Expander/Inflatable Tissue Expander." This type of document confirms that the device is substantially equivalent to legally marketed predicate devices and is allowed to be marketed.

However, it does not contain information about:

• Specific acceptance criteria for device performance.
• Results of a study proving the device meets acceptance criteria.
• Details about sample sizes, data provenance, expert qualifications, ground truth establishment, or statistical study designs (MRMC, standalone).

The document's purpose is regulatory clearance, not a detailed technical report of device validation studies.

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