(269 days)
The Natrelle® 133 Plus Tissue Expanders 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.
The Natrelle® 133 Plus Tissue Expanders are designed to develop tissue flaps as part of 2stage reconstruction mammoplasty. The devices are constructed from silicone elastomer and consist of an expansion envelope with a BIOCELL® textured surface, an orientation line, three suture tabs (optional), 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 expanded, 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 Tissue Expander, a medical device. This type of document is filed with the FDA to demonstrate substantial equivalence to a legally marketed predicate device, rather than to prove a device meets specific acceptance criteria based on a clinical study for AI or diagnostic performance. Instead, it focuses on non-clinical performance data and technological characteristics.
Therefore, the information requested in your prompt (acceptance criteria, study details, sample sizes, ground truth establishment, expert adjudication, MRMC studies, standalone performance, etc.) is not applicable to this document. This document does not describe a study proving a device meets acceptance criteria related to AI or diagnostic performance.
Explanation based on the provided text:
- Type of device: The Natrelle® 133 Plus Tissue Expander is a physical medical device (tissue expander made of silicone elastomer) used for breast reconstruction, scar revision, and tissue defect procedures. It is not an AI or diagnostic software/device.
- Purpose of the 510(k) submission: The primary goal of a 510(k) is to demonstrate that a new device is "substantially equivalent" to a predicate device already on the market. This means it has the same intended use and technological characteristics, or if there are differences, those differences do not raise new questions of safety or effectiveness.
- Performance Data mentioned: The document states: "Non-clinical performance data were submitted to support the substantial equivalence of the Natrelle® 133 Plus Tissue Expander to the predicate device. These data included biocompatibility data and mechanical testing data. 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 engineering and material testing (e.g., strength, durability, biocompatibility), not clinical diagnostic accuracy or AI performance. The "acceptance criteria" here would be specific thresholds for these physical properties and material safety, not metrics like sensitivity, specificity, or AUC for an AI model.
In summary, as this document pertains to a physical medical device and a 510(k) submission focused on substantial equivalence through non-clinical testing, the requested information about AI/diagnostic study setup is not present.
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