(266 days)
The Natrelle® 133 Plus MICROCELL™ Tissue Expander can be utilized for breast reconstruction after mastectomy, correction of an underdeveloped breast, scar revision, and tissue defect procedures. The expander is intended for temporary subcutaneous or submuscular implantation and is not intended for use beyond six months.
Natrelle® 133 Plus MICROCELL™ Tissue Expanders are designed to develop tissue flaps as part of 2-stage reconstruction mammoplasty. The devices are constructed from silicone elastomer and consist of an expansion envelope with a MICROCELL™ textured surface, an orientation line, three suture tabs, a MAGNA-SITE® integrated injection site, and a stable base to enable outward expansion. The tissue expanders are available in multiple styles and sizes to meet diverse surgical needs.
The MAGNA-SITE® injection site and MAGNA-FINDER® Xact external locating device contain rare-earth, permanent magnets for an accurate injection system. When the MAGNA-FINDER® Xact external locating device is passed over the surface of the tissue being expander, its rare-earth, permanent magnet indicates the location of the MAGNA-SITE® injection site. The injection site is self-sealing and includes a titanium needle guard to prevent inadvertent puncture through the base of the injection site.
The provided text is a 510(k) summary for the Natrelle® 133 Plus MICROCELL™ Tissue Expander. It describes the device, its intended use, and its technological characteristics. However, it does not contain information about a study that proves the device meets specific acceptance criteria in the context of an AI-powered diagnostic or assistive tool.
The "Performance Data" section states:
"Non-clinical performance data, including mechanical testing data and biocompatibility data, were submitted to support clearance of Natrelle® 133 Plus MICROCELL™ Tissue Expanders. Where appropriate, testing was conducted according to methods prescribed by relevant ASTM and/or ISO standards. All pre-established acceptance criteria were met."
This refers to physical device performance, mechanical properties, and biocompatibility, not the performance of an AI system, human-in-the-loop performance, or the use of ground truth established by experts.
Therefore, I cannot fulfill your request for the specific details outlined (AI performance metrics, sample sizes for AI training/test sets, expert adjudication methods, MRMC studies, standalone performance, or ground truth establishment for AI) because this information is not present in the provided document. The document pertains to a medical device (tissue expander), not an AI system.
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