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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; spinal tumor; and failed previous fusion (pseudarthrosis).

When used in a percutaneous approach with minimally invasive surgery (MIS) instrumentation, 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; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis).

The Salvo® Spine System is a thoracolumbosacral pedicle screw system designed through a posterior surgical approach. The implants are manufactured from titanium alloy (Ti-6Al-4V EL) per ASTM F136, commercially pure titanium per ASTM F67, cobaltchromium alloy per ASTM F 1537, and PEEK-OPTIMA LT1 with BaSO4. The System consists of a variety of screws, rods, and connectors that create a rigid construct as an adjunct to fixation and stabilization of the thoracic, lumbar, and sacral spine.

The provided text describes the 510(k) premarket notification for the Salvo® Spine System, a medical device. It does not contain information about a study proving that the device meets acceptance criteria related to an AI-driven or diagnostic system. The document focuses on regulatory approval based on substantial equivalence to predicate devices, rather than performance metrics of an AI model or a new diagnostic tool.

Therefore, I cannot extract the requested information (performance metrics, sample sizes, ground truth establishment, expert qualifications, etc.) as the document does not contain this type of data. The "Non-Clinical and/or Clinical Tests Summary & Conclusions" section explicitly states:

• "Nonclinical testing was performed on the Salvo® Spine System to support substantial equivalence to the predicate device. Dynamic axial compression bending testing per ASTM F1717 was performed."
• "Clinical testing is not applicable."

This indicates that the device's clearance is based on mechanical testing and comparison to existing devices, not on a study involving human readers, AI assistance, or the establishment of diagnostic thresholds.

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