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The TIMX Spine System is a pedicle screw system intended 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 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 TIMX Spine System is also indicated for pedicle screw fixation for the treatment of severe spondylolisthesis (Grades 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.

The TIMX Spine System is also a hook and sacral/iliac screw fixation system of the noncervical spine indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis), tumor, and previous failed fusion (pseudarthrosis).

The CrossOver Cross Connector is designed to transversely connect two rods used in spinal instrumentation constructs. The connector minimizes the torsional forces on the construct, thus reducing the micromotion and the probability of the construct shifting after placement.

The provided text is a 510(k) summary for the TIMX Spine System, specifically mentioning the CrossOver Cross Connector. It describes the device, its intended use, and materials. It also states that "Performance data were submitted to characterize the CrossOver Cross Connector." However, the document does not provide details about specific acceptance criteria, the study design, or the results of any performance studies in a way that would allow filling out the requested table or answering the specific questions about sample sizes, ground truth establishment, or expert involvement.

Therefore, the following information is not available in the provided text:

• A table of acceptance criteria and reported device performance.
• Sample sizes used for test sets or data provenance.
• Number of experts used to establish ground truth or their qualifications.
• Adjudication method for the test set.
• Information about Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
• Information about standalone algorithm performance studies.
• The type of ground truth used.
• Sample size for the training set.
• How the ground truth for the training set was established.

The document only broadly states that "Performance data were submitted to characterize the CrossOver Cross Connector." Without access to those submitted performance data, it is impossible to answer the specific questions posed.

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