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The SpineTune™ TL Spinal System is a posterior, noncervical pedicle fixation system indicated to provide immobilization and stabilization of spinal segments in skeletally-mature patients as an adjunct to fusion by autogenous bone graft in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar and sacral spine:

• Spondylolisthesis (Grade 3 and 4)
• Degenerative spondylolisthesis with objective evidence of neurological impairment
• Trauma (i.e., fracture or dislocation)
• Spinal stenosis
• Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis)
• Tumor
• Pseudoarthrosis
• Failed previous fusion

The Spinetune TL Spinal System is a top-loading posterior spinal fixation system consisting of pedicle screws, rods, set screws, transverse connectors and lateral, axial and domino type connectors.

This document describes a spinal fixation system, not an AI/ML powered device. As such, it does not contain information about acceptance criteria for device performance in the context of AI/ML, sample sizes for test or training sets, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.

The provided text is a 510(k) summary for the LDR Spine SpineTune™ TL Spinal System, a medical device for spinal fixation. It details the device description, its intended use, and states that "Non Clinical testing was not required" and that "The outcomes of verification and validation activities indicate that the propose SpineTune™ TL Spinal System is substantially equivalent to the predicate device."

Therefore, I cannot provide the requested information as it is not present in the provided text.

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