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The Rexious Spinal Fixation System is a posterior pedicle screw system indicated for the treatment of severe Spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

In addition, the Rexious Spinal Fixation System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic lumbar and sacral spine: degenerative Spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudarthrosis).

The Rexious Spinal Fixation System is a top-loading multiple component, posterior spinal fixation system which consists fixation system which consists of pedicle screws, rods, set screws, connectors, and a transverse (cross) linking mechanism.

The Rexious Spinal Fixation System will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion. The DIO Spinal System implant components are supplied non-sterile, single use and fabricated from titanium alloy (Ti-6A1-4V ELI) that conforms to ASTM F136. Various sizes of these implants are available.

The provided document does not contain information about acceptance criteria or a study proving the device meets them in the context of AI/ML or diagnostic performance. Instead, it is a 510(k) summary for a spinal fixation system, focusing on substantial equivalence to predicate devices for regulatory approval.

Key points from the document regarding "performance data":

• No new testing: "The addition of components to the system did not introduce a new worst case construct, and therefore no additional testing was performed."
• Substantial Equivalence: The conclusion is based on establishing substantial equivalence to predicate devices (e.g., Fixpine II System (K100765)) in terms of design, materials, indications, intended use, packaging, labeling, and performance.

Therefore, none of the specific questions related to AI/ML device performance (acceptance criteria, sample size, expert qualifications, adjudication, MRMC studies, standalone performance, ground truth, training set details) can be answered from this document. The "Performance Data" section in this submission refers to the mechanical performance and safety of the spinal implant, which is assessed through comparison to an existing device rather than through a clinical study with acceptance criteria as typically defined for diagnostic or AI/ML-driven devices.

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