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The Quantum Anterior Cervical Plate System is intended for anterior cervical fixation (C2-C7) in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (defined as neck pain of discogenic only with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (including fracture or dislocation), spinal stenosis, deformaties or curvatures (lordosis, kyphosis, or scoliosis), tumors, pseudoarthrosis, and failed previous fusion.

The Quantum Anterior Cervical Plate System is comprised of plates and screws that are used for attachment to the anterior cervical spine (C2-C7). Plates and screws are available in a variety of sizes to suit the individual pathology and unatomic condition of the patient. The device is manufactured from titanium alloy.

The provided text does not contain detailed acceptance criteria and the results of a study proving a device meets these criteria in the format requested.

The document is a 510(k) summary for the Quantum Anterior Cervical Plate System. It describes the device, its intended use, and states that substantial equivalence was shown to previously cleared devices. Under the "Performance Data" section, it only briefly mentions:

"Mechanical testing indicates that the Quantum Anterior Cervical Plate is capable of performing in accordance with its intended use."

This statement is very general and does not provide:

• Specific acceptance criteria: There are no quantifiable thresholds or targets mentioned for performance metrics.
• Detailed study results: There are no data tables, sample sizes, or methodologies of the mechanical testing.
• Information on ground truth, expert involvement, or comparative studies.

Therefore, I cannot populate the requested table or provide the detailed study information as the input text does not contain it. The document primarily focuses on establishing substantial equivalence to predicate devices, which often relies on comparison of design, materials, and intended use, rather than extensive new clinical or detailed standalone performance studies with specific statistical acceptance criteria.

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