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The Cyclone™ Anterior Cervical Plate System is a unilateral fixation device intended to provide stabilization during the process of cervical spinal fusion (C2-C7) in patients with degenerative disc disease (as defined by neck pain of discogenic origin of the disc confirmed by patient history and radiographic studies), trauma (including fractures). tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudoarthrosis, and/or failed previous fusions.

The Cyclone™ Anterior Cervical Plate System is a unilateral fixation device consisting of cervical plates (locking mechanism is pre-assembled to plates) and unicortical screws made from titanium alloy in conformance with ASTM F136. The plates are offered in one-level, two-level, three-level, and four-level fusion configurations (14mm-88mm). There are four different lengths of the standard 4mm diameter screw (12, 14, and 18mm). The rescue screw has a diameter of 4.4mm and lengths are 12, 14 and 16mm.

The provided text is a 510(k) summary for the "Cyclone™ Anterior Cervical Plate System" and an FDA clearance letter. It does not contain information about acceptance criteria, device performance studies, or AI/software analysis.

Therefore, I cannot populate the table or answer the questions you've posed as the necessary information is not present in the given document. The document describes a traditional medical device (a spinal plate and screws) and its regulatory clearance, not a software or AI-driven diagnostic device that would typically involve the kind of performance studies and ground truth establishment you're asking about.

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