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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.

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The DuralaBtic Anatomical Chin Implants are intended to be used to augment or reconstruct the maxilla for cosmetic or reconstructive surgery .

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 biocompatibility, mutagenicity, thoroughly tested -for 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.

The provided text is a 510(k) premarket notification document for Duralastic Malar Implants. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with acceptance criteria and results.

Therefore, the document does not contain the information required to answer the prompt.

Specifically, it does not include:

1. A table of acceptance criteria and reported device performance.
2. Details about sample sizes, data provenance, number of experts, adjudication methods for a test set.
3. Information on multi-reader multi-case (MRMC) studies or standalone algorithm performance.
4. The type of ground truth used, or details about training sets.

The document primarily describes the product, its intended use, physical properties, sterilization process, and concludes that it is substantially equivalent to a previously approved device (K952707) based on using the same molds and materials.

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