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The Valeo™ Cervical Plate System is intended for anterior screw fixation at the vertebral bodies of the cervical spine (C2-C7). The Valeo™ Cervical Plate System is indicated for use in temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with degenerative disc disease (as defined by neck pain in discogenic origin of the disc confirmed by patient history and radiographic studies), spinal stenosis, spondylolisthesis, deformity (defined as kyphosis, and scoliosis), trauma (including fractures), tumors, pseudoarthrosis, and/or failed previous fusions.

This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine. The device is intended for anterior cervical intervertebral body fusions only.

The Valeo™ Cervical Plate System is comprised of an assortment of titanium alloy plates and screws that act to stabilize the spine during the intervertebral fusion process. The Valeo™ Cervical Plate System is manufactured from wrought Ti-6A1-4V in accordance with ISO 5832-3.

The provided text describes a medical device, the "Valeo™ Cervical Plate System," and its 510(k) clearance by the FDA. However, it does not contain information about acceptance criteria, device performance, a specific study proving the device meets acceptance criteria, sample sizes, expert involvement, adjudication methods, or direct performance metrics for the device itself.

Instead, the document states:

• Performance Standards: "Testing performed on this device indicates that the Valeo™ Cervical Plate System is substantially equivalent to predicate devices. ASTM F1717 performance standards were adhered to and all applicable requirements were met."

This indicates that the device's substantial equivalence was established by demonstrating adherence to a recognized ASTM standard (F1717) and by comparison to existing predicate devices, rather than through a clinical study that measures specific acceptance criteria against reported device performance, as would be expected for an AI/CADe device.

Therefore, I cannot fulfill your request for the specific details outlined (points 1-9) because the provided text does not contain that type of information for this device submission. The device is a physical spinal fixation system, not an AI/CADe system, and its clearance relies on substantial equivalence and adherence to engineering standards for medical implants.

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