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The MEGA Spine System is a pedicle screw system 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 MEGA 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 spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudarthrosis).

The MEGA Spine System is a top-loading multiple component, posterior spinal fixation systems which consist of pedicle screws, rods, locking bolt, and a cross(transverse) linking mechanism.

The MEGA Spine System will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion. The MEGA Spine System implant components are supplied non-sterile, single use and fabricated from titanium alloy (Ti-6A1-4V ELI) that conforms to the ASTM F136. Various sizes of these implants are available. Specialized instruments are also available for the application and removal of the MEGA Spine System.

The provided document is a 510(k) summary for the MEGA Spine System, a medical device for spinal fixation. It describes the device, its indications for use, and its substantial equivalence to predicate devices based on mechanical testing. However, it does not contain the specific information required to complete the table and answer the study-related questions as it is not a study report on device performance but a premarket notification for regulatory approval.

Based on the provided text, here's what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that "Mechanical testing as listed in APPENDIX 9 that was conducted in accordance with ASTM F1717 demonstrates equivalence to the above listed predicate devices." However, it does not provide the specific acceptance criteria or the reported device performance metrics. Therefore, this table cannot be filled with the requested level of detail.

Missing Information for Complete Answer:

The following information is not present in the provided 510(k) summary:

2. Sample size used for the test set and the data provenance: This document does not detail specific sample sizes for mechanical testing or the origin of any data (e.g., country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This document is about mechanical testing of a medical device, not a performance study involving human interpretation or ground truth establishment by experts.
4. Adjudication method for the test set: Not applicable for mechanical testing.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical spinal implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for mechanical testing. The "ground truth" would be the ASTM standard and predicate device performance.
8. The sample size for the training set: Not applicable to this type of device and study.
9. How the ground truth for the training set was established: Not applicable to this type of device and study.

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