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The Proficient® Posterior Cervical Spine System is intended to immobilize the spine as an adjunct to fusion for cervical (C1-C7) and thoracic (T1- T3) spinal segments that have been affected by the following acute or chronic instabilities: traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g. pseudoarthrosis); tumors involving the cervical/thoracic spine; and degenerative diseases, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radios and degenerative disease of the facets with instability. The Proficient® Posterior Cervical Spine System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time in patients with advanced stage tumors involving the cervical spine whose life expectancy is insufficient to permit achievement of fusion. In order to achieve additional levels of fixation, the Proficient® Posterior Cervical Spine System may be connected to the CapSure® Spine System or the Sniper® Spine System using the Proficient® transition rods.

The subject Proficient® Posterior Cervical Spine System consists of a selection of non-sterile, single-use polyaxial screws, locking screws, rods, and connectors manufactured from titanium per ASTM F136 and ASTM F67 and cobalt-chrome allovs per ASTM F1537 and ASTM F1058. The rods, screws, and connectors are attached to the cervicothoracic spine of skeletally mature patients to stabilize the spine during fusion of vertebral bodies.

I am sorry, but the provided text does not contain information about the acceptance criteria and the study that proves a device (e.g., an AI-powered medical device) meets those criteria.

The document is a 510(k) premarket notification for a medical device called the "Proficient® Posterior Cervical Spine System," which is a spinal implant. It describes the device, its intended use, comparison to predicate devices, and mechanical performance testing to demonstrate substantial equivalence, such as:

• Dynamic axial compression bend testing
• Dynamic torsional testing
• Static and axial grip testing

This type of testing is to ensure the mechanical integrity and performance of the physical implant, not to validate criteria for an AI or software-based medical device as your request implies.

Therefore, I cannot extract the information required in your request, such as sample size for test sets, data provenance, number of experts for ground truth, MRMC studies, or training set details, because this document is about a surgical implant and not a software/AI device.

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