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The NuVasive® HELLX-T ACP System is intended for anterior screw fixation of the cervical spine. These implants have been designed to provide stabilization as an adjunct to cervical fusion. Indications for the use of this implant system include degenerative disc disease defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma, spinal stenosis, deformity, tumor, pseudarthrosis or failed previous fusion.

WARNING: The NuVasive HELIX-T ACP System is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.

The NuVasive Helix-T ACP System consists of a variety of types and sizes of plates and attachment screws .Implant components can be rigidly locked into a variety of different configurations to suit the individual pathology and anatomical conditions of the patient.

The provided text is a 510(k) summary for the NuVasive Helix-T Anterior Cervical Plate System. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it explicitly states "Summary of Clinical Tests (Not Applicable)" and only mentions "Mechanical testing was presented."

Therefore, the document does not contain information about specific acceptance criteria or a study proving the device meets those criteria in the context of clinical performance or diagnostic accuracy. It is for a physical medical device (an implantable plate and screw system) and its approval is based on substantial equivalence to an already marketed device, supported by mechanical testing, rather than a study demonstrating diagnostic or predictive performance.

As such, I cannot populate the requested table or answer the specific questions about sample sizes, expert ground truth, MRMC studies, or standalone performance, as this kind of data is not relevant to the information provided in this 510(k) summary.

In summary:

• Acceptance Criteria/Device Performance: Not applicable as no clinical study or diagnostic performance assessment is presented. The approval is based on substantial equivalence to a predicate device and mechanical testing (details of which are not provided in this summary).
• Sample size (test set), data provenance: Not applicable.
• Number of experts and qualifications: Not applicable.
• Adjudication method: Not applicable.
• MRMC comparative effectiveness study: Not applicable.
• Standalone performance: Not applicable.
• Type of ground truth: Not applicable.
• Sample size for training set: Not applicable.
• How ground truth for training set was established: Not applicable.

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