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The TOSCA II Anterior Cervical Plate System is intended for anterior cervical fixation 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), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis and/or lordosis), tumor, pseudarthrosis and failed previous fusion.
WARNING: The TOSCA II Anterior Cervical Plate System is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.

The TOSCA II Anterior Cervical Plate System comprises plate and screw components in a variety of sizes and lengths. Variable angle screws and a Center graft screw are offered.

The provided text is a 510(k) summary for the TOSCA II Anterior Cervical Plate System. It describes the device, its intended use, and states that substantial equivalence to a previously cleared device (TOSCA Anterior Cervical Plate System) was demonstrated based on equivalence in basic design, intended use, indications, anatomic sites, and performance.

However, the document does not contain specific information regarding acceptance criteria for device performance, the results of a study proving those criteria, or details such as sample sizes, ground truth establishment, expert qualifications, or MRMC studies.

Therefore, I cannot fulfill your request for this information from the provided text. The document primarily focuses on establishing substantial equivalence to a predicate device based on design and intended use, rather than presenting a detailed performance study with quantifiable acceptance criteria.

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