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When used as an anterolateral/anterior system, the levels of attachment are the lumbar, thoracic, and cervical spine. The points of attachment are screw fixation into the anterolateral vertebral bodies of the lumbar and thoracic spine (T1-L5) and anterior vertebral bodies of the cervical spine. The indications are degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, spinal stenosis, deformities (i.e., scoliosis, kyphosis, lordosis), tumor, pseudoarthrosis, or failed previous fusion.

When used as a nonpedicle, posterior system consisting of hooks, crosslinks, and sacral/iliac screws, the levels of attachment are the lumbar, thoracic, and cervical spine and the sacrum and ilium. The indications are degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, spinal stenosis, deformities (i.e., scoliosis, kyphosis, lordosis), tumor, pseudoarthrosis, or failed previous fusion.

When used as a pedicle screw system in the non-cervical spine of skeletally mature patient, the system is indicated for patients: (a) having severe spondylolisthesis (Grades 3 and 4) at L5-S1 joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (d) who are having the device removed after the development of solid fusion mass.

In addition, when used as a pedicle screw system in the non-cervical spine of skeletally mature patients, the system is intended to provide immobilization of spinal segments 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 (pseudoarthrosis).

The Surgical Dynamics Spiral Radius 90-D Rodding System is to be used in conjunction with the SDRS Spinal Rods, SDRS Spinal Rod with Sacral Eye and the SDRS Locking Screw.

The Spiral Radius 90-D Rodding System consists mainly of 1) screws and hooks that are implanted in vertebral bodies and 2) rods that fit into and are locked upon the screw heads using a locking cap. The system also includes crossbars that connect 2 parallel-running rods, offset screws and clips that allow a rod to be placed in certain situations where a direct connection to the vertebrae would cause excessive bending of the rod, and rod-to-rod connectors that allow a construct to be extended. All components of the system are composed of Ti-6Al-4V which conforms to ASTM F136.

The provided text describes the 510(k) summary for the "Spiral Radius 90-D Rodding System," a spinal fixation device. The focus of the provided document is on the regulatory submission for this medical device, including its description, indications for use, and a statement on substantial equivalence to predicate devices.

However, the provided text does not contain any information about acceptance criteria, device performance metrics (e.g., sensitivity, specificity, accuracy), or any details regarding a study that would prove the device meets specific acceptance criteria.

The "TESTING" section (marked as {1} in your input) briefly mentions:

"Mechanical testing was performed, including static and dynamic compression testing and static torsion testing."

This indicates that some form of testing was done to ensure the physical properties of the device. However, it does not provide:

• Specific acceptance criteria: What were the pass/fail thresholds for the compression and torsion tests?
• Reported device performance: What were the actual values obtained from these tests?
• Comparative data: How did these results compare to the predicate device or established standards?
• Study design details: No information about sample sizes for these mechanical tests, data provenance, ground truth establishment, or any clinical study involving human readers or AI algorithms is present.

Therefore, I cannot fulfill your request for a table of acceptance criteria, reported device performance, or details about studies involving human readers, AI, or specific ground truths, as this information is not present in the provided document.

The document's primary purpose is to establish substantial equivalence to a predicate device based on its design, materials, and intended use, rather than to report on detailed performance studies against quantitative acceptance criteria for software or diagnostic performance.

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