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The Salvo™ 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 chronic instabilities or deformities of the thoracic. lumbar, and sacral spine: degenerative disc disease; spondylolisthesis; fracture; dislocation; scoliosis; kyhosis; spinal tumor; and failed previous fusion (pseudarthrosis).

The modified Salvo™ Spine System is a thoracolumbosacral pedicle screw system designed to be implanted through a posterior surgical approach. The implants are manufactured from titanium alloy (Ti-6Al-4V) per ASTM F136, commercially pure titanium per ASTM F67, and cobalt-chromium alloy per ASTM F1537. The Salvo™ Spine System consists of a variety of screws, rods, and cross-connectors that create a rigid construct as an adjunct to fusion for internal fixation and stabilization of the thoracic, lumbar, and sacral spine.

I'm sorry, but this document does not contain the information required to answer your request. The provided text is an FDA 510(k) clearance letter and a 510(k) summary for the Salvo™ Spine System.

This type of FDA submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, primarily through comparison of design, materials, and performance testing data (e.g., mechanical tests like dynamic axial compression bend testing and static pull apart testing) to ensure the changed device meets existing standards. It does not typically involve:

• AI/Human-in-the-loop performance studies: The device is a thoracolumbosacral pedicle screw system, which is a physical implant, not an AI or software device.
• Acceptance criteria related to AI performance: There are no metrics like accuracy, sensitivity, specificity, or reader improvement to report.
• Sample sizes for AI training/test sets or ground truth establishment: These concepts are not applicable to a physical surgical implant.
• Expert adjudication or multi-reader multi-case studies: These are relevant for diagnostic devices interpreting medical images or data, not for orthopedic implants.

Therefore, I cannot extract any information related to acceptance criteria, study design, expert involvement, or AI performance as requested in your prompt. The document only confirms the device's clearance based on mechanical performance data demonstrating substantial equivalence to a predicate device.

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