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The Pre-Formed Silicone Block is intended for use in the cosmetic correction of soft tissue deformities, and is contoured at the surgeon's discretion to create a custom implant to aid in the reconstruction process.

The Pre-Formed Silicone Block is an implant intended to be used in the aesthetic (cosmetic) correction of soft tissue deformities. The Pre-Formed Silicone Block comes in multiple shapes and sizes (cup-shaped in small, medium and large; crescent-shaped, and rectangular block) and one durometer to accommodate a variety of surgical techniques and implantation sites. All implants are made from medical grade silicone and can be trimmed with a knife or scissors. The trimmable feature allows the surgeon to custom fabricate, at surgery, an implantable implant for a specific surgical indication. The implants are provided either sterile or non-sterile. Devices that are provided non-sterile must be sterilized prior to use.

The provided text is a 510(k) Summary for a medical device (Pre-Formed Silicone Block). This document describes the device, its indications for use, and a comparison to predicate devices to demonstrate substantial equivalence, rather than detailing a study that proves the device meets specific acceptance criteria through performance evaluation.

Therefore, the information required to answer the prompt (acceptance criteria, device performance results, sample sizes, expert ground truth establishment, MRMC studies, standalone performance, etc.) is not present in the provided text. The document states:

• "No additional testing was provided in this submission in order to demonstrate substantial equivalence."
• "Previous testing (i.e., biocompatibility, sterilization, and non-clinical performance testing) was leveraged to support a demonstration of substantial equivalence." (This implies that this specific submission did not include new performance studies comparing the device to acceptance criteria, but rather relied on comparisons to previously cleared devices and existing safety/biocompatibility data.)

In summary, the provided FDA 510(k) summary does not contain the information requested about performance studies, acceptance criteria, or their results. It primarily focuses on demonstrating substantial equivalence to predicate devices based on shared characteristics.

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