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The Mercury® Spinal System is intended to provide immobilization of the spine in skeletally mature patients as an adjunct to fusion for procedures of the thoracic, lumbar, and sacral spine (T1-S1). Screws may be placed from the thoracic spine through the sacral spine and into the iltum. This system is intended for anterior/anterolateral nonpedicle fixation, posterior non-pedicle fixation, and posterior pedicle fixation for the following indications: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

This system is intended to be used with bone graft.

Spinal Elements' Mercury Spinal System is comprised of a variety of screws, hooks, rods, connectors, and staples that are used for attachment to the non-cervical spine (the thoracic spine through the sacrum and in the ilium). A variety of constructs may be assembled to suit the individual pathology and anatomy of the patient. Rods span the distance between screws and hooks and achieve fixation by the mechanical joining of the rods with the screws or hooks. Connectors are used to mechanically join one rod to another. Staples (when used) are placed under the head of the screws to help distribute loads placed against the bone.

Screws, hooks, rods, connectors, and staples are made from titanium alloy (Ti-6A1-4V) conforming to ASTM F 136 and ISO 5832-3 or ASTM F 1472. Additionally, some rods may be manufactured from cobalt chromium alloy (Co-Cr) conforming to ASTM F 1537 and ISO 5832-12.

The provided document, K141372, is a 510(k) premarket notification for the Mercury® Spinal System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through a clinical study or comprehensive performance evaluation with AI.

Therefore, the document does not contain the information requested regarding acceptance criteria, study methodologies, sample sizes, expert qualifications, or ground truth establishment relevant to an AI/ML medical device.

The "Performance Data" section briefly mentions:

• Static Axial Grip and Torsional Grip Interconnection Testing per ASTM F 1798
• Static Compression, Static Torsion, and Dynamic Compression Construct Testing per ASTM F 1717

These are mechanical and materials testing standards for spinal implant systems, not studies involving AI or human interpretation of medical images. The conclusion, "All data indicates that the device will perform as intended," refers to these engineering tests.

In summary, none of the requested information regarding acceptance criteria and study data for an AI/ML medical device can be extracted from this document.

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