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The uNion™ Cervical Plate System is intended for anterior fixation of the cervical spine (C2 to T1). The system is to be used to provide stabilization of the anterior cervical spine as an adjunct to fusion for the treatment of degenerative disc disease (defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), tumors, spinal stenosis, deformity (i.e., kyphosis, lordosis or scoliosis), pseudarthrosis or failed previous fusion.

uNion™ is an anterior cervical plate and screw system used to provide mechanical support across implanted level(s) in the cervical spine until fusion is achieved. The components include Ø4.0mm and Ø4.5mm fixed and variable screws having self-tapping, self-drilling or self-drilling/self-tapping tips, one- through four-level standard plates having lengths from 10mm to 84mm and one- and two-level midline plates having lengths from 10mm to 46mm. Both the standard and the midline plates incorporate a pivoting insert which functions as an anti-back out mechanism. The devices are sold non-sterile.

The provided text describes a 510(k) Pre-market Notification for the uNion™ Cervical Plate System, focusing on its substantial equivalence to predicate devices based on mechanical testing. It does not contain information about an AI/ML device or its performance study against acceptance criteria in the way described in the prompt. Therefore, I cannot extract the requested information.

The document discusses:

• Device: uNion™ Cervical Plate System (a medical implant for spinal fixation).
• Regulatory Category: Class II, Spinal intervertebral body fixation orthosis.
• Purpose of filing: 510(k) Pre-market notification to demonstrate substantial equivalence to legally marketed predicate devices.
• Performance Data: Mechanical testing of worst-case uNion™ constructs (static and dynamic compression bending, static torsion) according to ASTM F1717.
• Conclusion: The mechanical test results showed that the uNion™ performance is substantially equivalent to the predicate devices.

None of the requested information regarding acceptance criteria, AI/ML performance study, sample sizes for test/training sets, ground truth establishment, or expert adjudication is present in the provided text, as it pertains to a traditional medical device, not an AI/ML system.

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