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When used as an intervertebral body fusion device, the Guided Lateral Interbody Fusion (GLIF) System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients should have had six months of non-operative treatment. The GLIF System is to be used with a supplemental fixation system and autogenous bone graft.

When used as a vertebral body replacement device, the Guided Lateral Interbody Fusion (GLIF) system is intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged or unstable vertebral body due to tumor or trauma (i.e. fracture). The GLIF System is intended for use with supplemental spinal fixation system. Specifically the GLIF System is to be used with Alphatec Zodiac Polyaxial Spinal Fixation System or the Alphatec Mirage Top Tightening Spinal System. Furthermore the GLIF System is intended for use with allograft.

The Guided Lateral Interbody Fusion (GLIF) System will be comprised of interbody implants, curved access instruments and specialized disc preparatory instruments. The Guided Lateral Interbody Fusion (GLIF) System provides a lateral approach to the spine from a posterior angle while the patient is in the prone position. The lateral access technique allows a larger cage to be implanted similar to an anterior lumbar interbody fusion sized cage and patient is already in the prone position which eliminates the need to break the sterility field and flip the patient for supplemental fixation.

The provided text describes a 510(k) summary for the "Guided Lateral Interbody Fusion (GLIF) System." This submission is for a medical device that is an intervertebral body fusion device and vertebral body replacement device, not a diagnostic AI/ML algorithm.

Therefore, the requested information regarding acceptance criteria and study details for an AI/ML device (such as sample size for test/training sets, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance) is not applicable to this document.

The "Performance Data" section states:

"The test results demonstrate that the mechanical performance of the GLIF System is substantially equivalent to the predicate device."

This indicates that the acceptance criteria and study for this device focused on demonstrating mechanical performance and substantial equivalence to existing, legally marketed devices (predicates), specifically the Novel Spinal Spacer System (K080699) and the Nuvasive CoRoent (K071795). These tests would typically involve bench testing for material properties, fatigue, subsidence, and other biomechanical characteristics relevant to an implantable device, rather than studies involving human readers or AI algorithm performance.

In summary, none of the requested information regarding acceptance criteria for an AI/ML device is available in this document because it pertains to a physical surgical implant, not an AI/ML diagnostic or assistive tool.

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