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Posterior pedicle screw fixation: The Rogozinka Spinal Rod System Direct ("U"-shaped head) and Offset ("T"-shaped head) screws when placed in the vertebral levels L3 to S1 are intended only for patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar - first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; and (c) who are having the device fixed or attached to the lumbar and sacral spine. Other and Offset Screws are intended only for sacral/iliac attachment as specified below.

Posterior hook and/or sacral/iliac screw fixation: The Rogozinski Rod System is intended for the treatment of degenerative disc disease (defined as spinal instability and one of the following: decreased disc height, ridging of vertebral end plates, scaring or thickening of ligamentous tissues and/or change in the facet process), scoliosis; spondylolisthesis; fracture; unsuccessful previous attempts at spinal fusion; or tumor resection. The Rogozinski Thoracolumbar Spinal Rod system is limited to non-cervical use.

The Rogozinski Thoracolumbar Spinal Rod System consists of two stainless steel rods attached to the spinal column through the use of hooks and/or screws. Universal cross-bars may be used to connect rods to provide a more rigid construct, as well as screws to rods and hooks to rods. Screws are provided in a variety of lengths and in up-angle, neutral, down-angle and pedicle hooks are provided in several sizes to accommodate varying patient morphology. Screws used with this system feature a "T" shaped head for offset attachment to the rod using a coupler, crossbar, and set screw or a "T"-shaped head for direct attachment to the rod use screw. Up-angle, down-angle, neutral and pedicle hooks may be attached either directly to the rod or offset from the rod attached with to the rod with a crossbar mechanism.

The provided text describes a spinal rod system and references several studies to support its safety and effectiveness. However, it does not include specific acceptance criteria for the device's performance, nor does it present a study proving the device meets such criteria directly.

Instead, the documents focus on demonstrating substantial equivalence to predicate devices and supporting the overall clinical utility and safety of pedicle screw fixation through meta-analyses, historical cohort studies, and randomized trials of similar systems or approaches, rather than directly evaluating the "Rogozinski Thoracolumbar Spinal Rod System Smith & Nephew Spine" against predefined performance metrics.

Therefore, I cannot provide a table of acceptance criteria and reported device performance as that information is not present. I can, however, extract details about the referenced studies that informed the device's acceptance.

Here's an analysis of the provided text based on your requested information, highlighting what is missing and what can be inferred:

1. Table of Acceptance Criteria and Reported Device Performance

• Acceptance Criteria: Not explicitly stated. The document does not define specific numerical thresholds (e.g., fusion rate > X%, complication rate

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