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The Global Spinal Fixation System is a pedicle screw indicated for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

In addition, the GSFS is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairement, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

The Global Spinal Fixation System (GSFS) is a multiple component system comprised of a variety of single-use, non-sterile devices that allow the surgeon to build a spinal implant construct in order to provide stabilization and promote spinal fusion. The implants are manufactured from titanium allov. Ti6A14V that conforms to ASTM 136 98 and include pedicle screws, hooks, rods, cross link, and connector. Various sizes of these implants are available. Specialized instrument made from surgical instrument grade stainless steel is available for the application and removal of the GSFS implants.

I am sorry, but the provided text does not contain any information regarding acceptance criteria, device performance, sample sizes, data provenance, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone algorithm performance, or ground truth establishment for a medical device.

The text is a summary of safety and effectiveness information for the "Global Spinal Fixation System," a spinal implant. It describes the device, its indications for use, and confirms its substantial equivalence to a predicate device. It also includes the FDA's clearance letter for the device.

Therefore, I cannot fulfill your request to create a table of acceptance criteria and device performance, or provide details about the studies you've specified, as this information is not present in the provided document.

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