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The Mega Plus Spine System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chromic instabilities of the thoracic, lumbar, and sacral spine: degenerative disc disease; spondylolisthesis; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis).

The Mega Plus Spine System 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 disc disease; spondylolisthesis; fracture; dislocation; scoliosis; spinal tumor; and failed previous fusion (pseudarthrosis).

The Mega Plus Spine System is a top-loading multiple component, posterior spinal fixation system which consists of pedicle screws (multi-axial, multi-axial long arm, mono and long-arm), iliac screws, rods, locking bolts, cross-links, and connectors. The Mega Plus Spine System will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion. The Mega Plus Spine implant components are supplied non-sterile, single use and fabricated from titanium alloy (Ti-6Al-4V ELI) that conforms to ASTM F136 or cobalt chromium alloy (Co28-Cr6-Mo) that conform to ASTM F1537. Various sizes of these implants are available. Specialized instruments are also available for the application and removal of the Mega Plus Spine System. Modifications to the Mega Plus Spine System from the clearance in K173180 include the addition of CoCr rods, the addition of LED and deformity type rods, and the inclusion of non-anodized screws for all screw types and sizes.

I am sorry, but the provided text does not contain information about the acceptance criteria and the study that proves the device meets the acceptance criteria in the format requested. The document is a 510(k) summary for a medical device (Mega Plus Spine System) and primarily focuses on demonstrating substantial equivalence to predicate devices, rather than detailing specific performance criteria or a study designed to prove those criteria.

Therefore, I cannot generate the table or answer the specific questions about sample size, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth, or training set details.

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