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The PROVIDENCE™ Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine C2-C7 for the following indications: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudarthrosis, failed previous fusion, spondylolisthesis, and spinal stenosis.

The PROVIDENCE™ Anterior Cervical Plate System consists of plates used with either variable or fixed angle screws. The plate attaches to the anterior portion of the vertebral body of the cervical spine (levels C2-C7). The implants are composed of titanium alloy, as specified in ASTM F136, F1295.

The provided text describes a 510(k) summary for the PROVIDENCE™ Anterior Cervical Plate System. It focuses on the device's description, intended use, and substantial equivalence to a predicate device, supported by mechanical testing. However, it does not include the information requested in your prompt regarding acceptance criteria, device performance, study details (sample sizes, data provenance, expert involvement, adjudication, MRMC studies, standalone performance), or ground truth establishment.

A 510(k) submission primarily demonstrates that a new device is substantially equivalent to a legally marketed predicate device. This often relies on comparing technical characteristics and performance data (like mechanical testing, as mentioned here) to show that the new device is as safe and effective as the predicate. It typically does not involve the types of human-reader or diagnostic performance studies that are relevant to your inquiry, especially for devices like spinal plate systems.

Therefore, I cannot fulfill your request using the provided input as the necessary information is not present.

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