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The Lanx Spinal Fixation 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: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; spinal tumor; and failed previous fusion (pseudarthrosis).

The Lanx Spinal Fixation System is a posterior attachment pedicle fixation system. The system is made up of a series of screws, rods, cross-links and interlocking mechanisms. Materials: Titanium Alloy ASTM F136-92 ISO 5832-3

The provided text is a 510(k) Summary for the Lanx Spinal Fixation System, which is a medical device for spinal fixation. It details the device's name, classification, predicate device equivalence, description, materials, and intended use.

No study proving the device meets specific acceptance criteria is described in this document. The document states that "Fatigue and static testing conducted in accordance with ASTM F-1717-01 are complete. The test results demonstrate that the device will perform in a manner substantially equivalent to available spinal fixation systems." This indicates that the device underwent standard mechanical testing for spinal fixation systems and demonstrated equivalence to existing, legally marketed devices, which is the basis for its 510(k) clearance.

Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes for test/training sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance, as these are not present in the provided text.

The closest information related to "acceptance criteria" is that the device "meets required general controls authorized under Sections 501, 502, 510, 516, 518, 519, and 520 of the Food, Drug, and Cosmetic Act" and passed "Fatigue and static testing conducted in accordance with ASTM F-1717-01." However, these are regulatory and standard testing requirements, not specific performance acceptance criteria for a study as typically outlined for AI/software devices.

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