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The EBI® Top Loading MAS 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 lordosis), tumor, stenosis, psuedoarthrosis, and failed previous fusion.

The EBI® Top Loading MAS Spinal Fixation System is a single use spinal fixation device that utilizes rods, screws, and hooks.

The provided text describes a 510(k) premarket notification for the EBI® Top Loading MAS Spinal Fixation System. However, it does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details.

The document primarily focuses on establishing substantial equivalence to predicate devices, describing the device, its intended use, materials, and product classification. There is no performance data or study methodology presented.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets those criteria based on the provided input.

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