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

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 to transfix the joint. The SurGenTec TiLink-P SI Joint Fixation System includes TiLink Implants and associated Instruments. The TiLink-P SI Joint Fusion System fixates the sacroiliac joint by transfixing the cortices of the ilium and cortices of the sacrum.

The TiLink-P Compression Anchor is positioned so that it spans the cortices of ilium and cortices of sacrum, the TiLink-P Locking Screw is inserted through the TiLink-P Compression Anchor and across the SI Joint via a lateral approach, compressing the joint. Bone graft material is used with the TiLink-P SI Joint Fusion System to facilitate bone growth.

The provided text is a 510(k) Premarket Notification from the FDA for a medical device called the "TiLink-P Joint Fusion System." The purpose of these notifications is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device, meaning it's as safe and effective.

The type of "device" in question here is a system of orthopedic implants and instruments used for sacroiliac joint fusion. This is a physical medical device, not software or an AI algorithm. Therefore, the questions related to "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of an AI/software device do not apply to this document.

The document describes performance testing for the physical device, which involves mechanical tests to ensure its structural integrity and functionality, rather than clinical performance based on an AI model's output.

Here's why the AI/software-related questions cannot be answered from this document:

• No AI or Software Component: The 510(k) summary explicitly describes the TiLink-P Joint Fusion System as "various orthopedic instruments to assist the user in implanting a titanium sacroiliac implant" and "TiLink Implants and associated Instruments." There is no mention of any AI, machine learning, or software component that would require assessment of diagnostic accuracy, image performance, or human-AI collaboration.
• Focus on Substantial Equivalence: The entire premise of a 510(k) is to prove substantial equivalence to a predicate device. This typically involves comparing indications for use, technological characteristics, materials, and mechanical performance for physical devices. It does not involve evaluating "device performance" in terms of diagnostic accuracy or impact on human readers, which are typical for AI/software clearances.
• Performance Testing Summary: The "Performance Testing Summary" lists "Axial Pullout Testing per ASTM F543," "Torsional Properties per ASTM F543-17," and "Static and Dynamic Cantilever Test per ASTM F3574." These are all standard mechanical tests for orthopedic implants, ensuring they can withstand physiological loads. They are not studies of algorithm performance.

Therefore, I cannot provide answers to the questions you've asked because they are tailored for AI/software-based medical devices, and the provided document describes a physical orthopedic implant system.

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