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The TiLink-P Joint Fusion System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.

The TiLink-P SI Joint Fusion System contains various orthopedic instruments to assist the user in implanting a titanium sacroiliac implant into the sacroiliac joint. The SurGenTec TiLink-P SI Joint Fixation System includes TiLink Implants and associated Instruments (sterile or non-sterile). The TiLink-P SI Joint Fusion System may be used via lateral or posterior oblique. Bone graft material is used with the TiLink-P SI Joint Fusion System to facilitate bone growth.

This document is a 510(k) premarket notification decision letter from the FDA to SurGenTec LLC for their TiLink-P SI Joint Fusion System. It states that the device has been determined to be substantially equivalent to legally marketed predicate devices.

Based on the provided text, the device discussed is NOT an AI/ML medical device. The document describes a physical medical device (components of a sacroiliac joint fusion system) and its mechanical, material, and biological performance testing.

Therefore, the requested information regarding "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of AI/ML performance (e.g., sensitivity, specificity, MRMC studies, ground truth establishment with experts) is not applicable to this submission.

The document discusses performance testing relevant to a physical implantable device, such as:

• Axial Pullout Testing per ASTM F543: This likely measures the force required to pull the implant out of bone, assessing its fixation strength.
• Static and Dynamic Cantilever Test per ASTM F3574: This assesses the implant's resistance to bending under various loading conditions, relevant for its structural integrity.
• Sterilization, Packaging, and Shelf-Life Validations: These ensure the device remains sterile and functional over time.
• Biocompatibility Assessment per ISO 10993: This confirms the materials used in the device are safe for contact with human tissue.

The "acceptance criteria" for these tests would be specific parameters and thresholds (e.g., minimum pullout force, maximum deflection under load) defined by the manufacturer and often guided by relevant ASTM/ISO standards. The "study" proving it meets these criteria would be the results of the physical tests.

Since the prompt specifically asks for details relevant to an AI/ML device, and this document does not pertain to AI/ML, I cannot provide the requested information in that context.

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