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The EBI Omega21 Spinal Fixation System is a non-cervical spinal fixation device intended for use as a pedicle screw fixation system, a posterior hook and sacral/iliac screw fixation system, or as an anterolateral fixation system. Pedicle screw fixation is limited to skeletally mature patients. The device is indicated for all of the following indications regardless of the intended use: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, kyphosis, and or lordosis), tumor, stenosis, pseudoarthrosis, and failed previous fusion.

The EBI® Omega21 Spinal Fixation System is a spinal fixation device that utilizes rods, screws, couplers and hooks. This submission is for the modification to the Indications for Use.

The provided document is a 510(k) summary for a spinal fixation system, not a study evaluating an AI/ML device. Therefore, it does not contain information related to acceptance criteria, device performance, sample sizes, ground truth establishment, or clinical study methodologies typically associated with AI/ML device evaluations.

The document is primarily focused on demonstrating substantial equivalence of the EBI® Omega21™ Spinal Fixation System to previously marketed predicate devices, as required for FDA clearance. It describes the device, its intended use, materials, and compares its technological characteristics to existing devices.

Therefore, I cannot extract the requested information as it is not present in the provided text.

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