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Fixation of C1-C2 in case of fracture or multi-operated back.

The J.B.S. Posterior C1-C2 Clamp System is a single-use. temporary device used for fixation of the C1-C2 vertebrae. The System is to be removed after fusion occurs. It consists of a cervical hook, a superior hook, a linking screw and a locking screw. All these components are made of surgical implant titanium with the composition Ti-6AL-4V ELI according to ASTM-136-92 or ISO 5832-3-90.

The provided text describes a medical device called the "J.B.S. POSTERIOR C1-C2 CLAMP SYSTEM®", which is a spinal fixation device. However, the text is a 510(K) summary for a medical device and does not contain any information about acceptance criteria or a study proving that the device meets those criteria, particularly in the context of an AI/algorithm-driven device.

The request asks for information relevant to the testing and evaluation of an AI-driven medical device, including aspects like sample size for test and training sets, ground truth establishment, expert qualifications, and multi-reader multi-case studies. These concepts are not applicable to the non-AI, mechanical spinal clamp system described in the input.

Therefore, I cannot fulfill the request using the provided input. The input describes a physical medical implant, not an AI/algorithm device.

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