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

The 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 ELI) per ASTM F136, commercially pure titanium per ASTM F67, cobalt-chromium alloy per ASTM F1537, and PEEK-OPTIMA LT1 per ASTM F2026. The Salvo® Spine System consists of a variety of screws, rods, and connectors that create a rigid construct as an adjunct to fusion for internal fixation and stabilization of the thoracic, lumbar, and sacral spine.

This FDA 510(k) clearance letter and summary are for a spinal implant system (Salvo® Spine System), not an AI/ML medical device. Therefore, the information requested in your prompt (e.g., acceptance criteria for device performance in terms of AI metrics, sample sizes for AI training/test sets, ground truth establishment, MRMC studies) is not applicable or present in the provided text.

The document describes the Salvo® Spine System as a thoracolumbosacral pedicle screw system, which is a physical implant used in spinal fusion surgery. The "performance data" section refers to nonclinical (mechanical) testing of the implant itself, to ensure its structural integrity and comparability to a predicate device.

Therefore, I cannot provide the requested information based on the given text.

If you have a document related to an AI/ML medical device, please provide that, and I will be happy to extract the relevant details.

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