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The SIS Facial Implant is intended for use to provide soft tissue repair or reinforcement in plastic and reconstructive surgery of the face and head. The device is supplied sterile and is intended for one-time use.

The SIS Facial Implant is manufactured from porcine small intestinal submucosa (SIS) and is nominally supplied in a strand configuration pre-attached to a trocar. The device is packaged in a lyophilized (dried) state, and supplied sterile in a sealed double pouch system.

The provided text is a 510(k) summary for the SIS Facial Implant. It describes the device, its intended use, predicate devices, and the conclusion of substantial equivalence based on testing. However, it does not contain a detailed study report with specific acceptance criteria or an analysis of device performance against those criteria.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor can I answer questions about sample sizes, data provenance, expert involvement, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.

The document primarily focuses on demonstrating substantial equivalence to predicate devices through biocompatibility, viral inactivation, and mechanical testing, but the results of these tests in a quantifiable manner against specific criteria are not detailed in this summary.

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