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The SpineWorks FixxSure Cross Link is intended work with the Talon Pedicle Screw system to provide immobilization and stabilization 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 thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis).

The SpineWorks FixxSure Cross Link must be used with the Talon Pedicle Screw system.

The SpineWorks FixxSure Cross Link allows spinal surgeons to convert a dual-rod construct into a frame and increase overall construct strength. The FixxSure Cross Link comes in a multi-span and fixed design, both of which can be rigidly locked onto a dual-rod construct and has the capability of being manipulated into various planes of angulation. The SpineWorks implant has a proprietary dual locking mechanism allowing maximum Cross Link/rod connection while offering superior ease of insertion/use.

The provided text describes a 510(k) premarket notification for a medical device called the SpineWorks FixxSure Cross Link. It is a submission to the FDA seeking to demonstrate substantial equivalence to legally marketed predicate devices, not a study evaluating the device's performance against specific acceptance criteria in a clinical setting with AI.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details cannot be extracted from this document.

The document states:

• Nonclinical Tests: "Testing was conducted according to ASTM F1717 and F1798 with adequate strength." This refers to mechanical and material testing, not clinical performance or AI evaluation.
• Comparison: "The FixxSure Cross Link is similar to the predicate device in terms of material, design and indications." This is the basis for the 510(k) submission (substantial equivalence), not a detailed performance study against specific criteria.

In summary, this document does not contain the information required to populate the requested table and provide descriptions of a study proving the device meets acceptance criteria related to AI or clinical performance.

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