(35 days)
To augment or reconstruct the malar cheek contour or the maxillary Zygoma.
Duralastic Malar implants are crescent shaped concave convex silicone elastomer rubber implants made from specially formulated silicone elastomers designed for implantation. They are manufactured in pairs with a mirror image left and right. The LSR 30 Implant Grade elastomer is Masterfiled at FDA and has been thoroughly tested for mutagenicity, biocompatibility, carcinogenicity, and cytotoxicity. These referenced material characterizations are found in Applied Silicone's Master File MAF-562. The Duralastic Malar Implants will be provided sterile and nonsterile.
I'm sorry, but your input refers to a 510(k) submission for Duralastic Malar Implants, which are physical silicone elastomer implants for cosmetic and reconstructive surgery. The documents describe the product, its materials, intended use, sterilization, and its substantial equivalence to a predicate device.
The information you are requesting, such as acceptance criteria tables, sample sizes for test and training sets, expert qualifications, adjudication methods, and details about AI/ML algorithm performance (like MRMC studies or standalone algorithm performance), are not applicable to this type of medical device submission. These types of criteria and studies are typically associated with the evaluation of software as a medical device (SaMD), especially those incorporating artificial intelligence or machine learning, which rely on data and algorithms for their function.
Therefore, I cannot provide the requested information from the given text because it is not relevant to the Duralastic Malar Implants submission.
§ 878.3550 Chin prosthesis.
(a)
Identification. A chin prosthesis is a silicone rubber solid device intended to be implanted to augment or reconstruct the chin.(b)
Classification. Class II.