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The Soft Tissue Augmentation Resorbable (STAR) Matrix is intended to support localized gingival augmentation to increase keratinized tissue.

STAR Matrix is indicated for:

• Covering of implants placed in immediate or delayed extraction sockets;
• Localized gingival augmentation to increase keratinized tissue (KT) around teeth and implants.

The Soft Tissue Augmentation Resorbable Matrix (STAR Matrix) is a cross – linked, resorbable membrane engineered from highly purified Type I collagen fibers derived from Porcine Achilles Tendon for use in periodontal, oral, and maxillofacial surgery. STAR Matrix is composed of two structures: a smooth outer layer that acts as a barrier membrane and a porous matrix layer to allow cell invasion and tissue ingrowth. The product is oriented so that the porous layer is in contact with the host tissue bone/bone graft or periosteum to facilitate tissue integration. The product is provided sterile, non-pyrogenic, and for single use only. Product is provided in various sizes where it can be easily trimmed for appropriate fit and sutured into place during surgery.

The provided document is a 510(k) summary for a medical device (Soft Tissue Augmentation Resorbable Matrix - STAR Matrix) and focuses on demonstrating substantial equivalence to a predicate device. It does not contain information about acceptance criteria and a study proving the device meets those criteria, as typically found in a clinical study report for software as a medical device (SaMD) or AI/ML-driven devices.

The document primarily covers:

• Description of the device: A resorbable membrane for gingival augmentation.
• Comparison to predicate devices: Highlighting similarities and differences in technical characteristics.
• Performance data: Primarily non-clinical (in vitro, animal, biocompatibility, sterilization, shelf life).
• No clinical studies were required to determine substantial equivalence for this device.

Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving a device meets those criteria because the document does not describe such a study. The information requested (acceptance criteria table, sample sizes, ground truth establishment, expert adjudication, MRMC studies, standalone performance, training set details) is typically found in documentation for the validation of AI/ML-based medical devices or devices demonstrating clinical efficacy/safety through trials, which is not the nature of this 510(k) submission.

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