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The AXIS 5.5 LUMBAR PEDICLE SCREW SYSTEM is intended for posterior, non-cervical fixation of skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis and/or lordosis); tumor; pseudarthrosis; and/or failed previous fusion.

The AXIS 5.5 LUMBAR PEDICLE SCEW System consists of a variety of shapes and sizes of rods, screws, Crosslink plates, which can be rigidly locked into a variety of configurations, with each construct being tailormade for the individual case.

The AXIS 5.5 LUMBAR PEDICLE SCEW System implant components are fabricated from medical grade titanium alloy described by such standards as ASTM F67 or ASTM F136 or ISO 5832-3 or 5832-2.

This document is a 510(k) premarket notification for the AXIS 5.5 Lumbar Pedicle Screw System. It describes the device, its intended use, and provides evidence of substantial equivalence to predicate devices. However, it does not contain information about an AI/ML-driven medical device or studies related to its acceptance criteria and performance.

Therefore, I cannot provide the requested information about acceptance criteria and study details for an AI-driven device based on the provided text. The document pertains to a mechanical orthopedic implant.

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