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The Valeo™ Pedicle Screw System is intended for noncervical pedicle fixation from the T1 to L5 vertebrae in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudarthrosis; and failed previous fusion.

The Valeo™ Pedicle Screw System comprises non-sterile, single use, titanium allov components for creating a posterior spinal implant construct. The system attaches to the spine through a component system comprising screws, rods, connectors, and set screws. The system is designed to stabilize the spine during the fusion process. The ValeoTM Pedicle Screw System is fabricated from wrought Ti-6A1-4V (ISO 5832-3).

This document is a 510(k) summary for the Valeo™ Pedicle Screw System. It describes the device, its indications for use, and its substantial equivalence to predicate devices. However, this document does not contain any information regarding clinical studies, acceptance criteria for device performance (beyond substantial equivalence to predicate devices), or specific performance metrics.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, nor can I provide information about:

1. A table of acceptance criteria and the reported device performance
2. Sample sizes used for the test set and data provenance
3. Number of experts used to establish ground truth and their qualifications
4. Adjudication method
5. MRMC comparative effectiveness study results or effect sizes
6. Standalone algorithm performance
7. Type of ground truth used
8. Sample size for the training set
9. How ground truth for the training set was established

The document primarily focuses on establishing substantial equivalence based on design, function, and materials to previously cleared devices. The "Performance Standards" section merely states "Testing performed indicates the Valeo™ Pedicle Screw System is substantially equivalent to predicate devices," but it does not detail what that testing entailed or what the specific performance criteria or results were.

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