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The Moss Miami 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 Moss Miami 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 Moss Miami Spine System is also a hook and sacral/iliac screw fixation svstem 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), turnor, 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. It is designed to accommodate the 5.0mm and 6.35mm spinal rods of the Moss Miami Spine System

The provided text is a 510(k) summary for the DePuy AcroMed, Inc. CrossOver Cross Connector, a spinal fixation device. It details the device's description, intended use, materials, and predicate devices. However, the document does not contain any information regarding acceptance criteria for device performance or a study proving the device meets acceptance criteria.

The section labeled "PERFORMANCE DATA:" directly states:

Performance data were submitted to characterize the CrossOver Cross Connector.

This indicates that some performance data was submitted, but the document itself does not elaborate on what that data entails, what acceptance criteria were used, or the results of any specific studies.

Therefore, I cannot provide the requested information in the table or answer the subsequent questions based on the provided text. The document is primarily a regulatory filing (510(k) summary) focused on demonstrating substantial equivalence to a predicate device, rather than a detailed report of a performance study with specific acceptance criteria.

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