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The EBI SpineLink™ System is a spinal fixation device for pedicle screw fixation and a nonpedicle hook and sacral/iliac screw fixation system of the noncervical spine.

When used as a pedicle screw fixation system, in the non-cervical spine of skeletally mature patients, the System is intended to provide immobilization and stabilization 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 neurologic impairment, fracture, dislocations, scoliosis, kyphosis, spinal tumor, and failed previous fusion (psuedarthrosis).

In addition, when used as a pedicle screw fixation system in skeletally mature patients, it is intended 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; (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 a solid fusion mass.

When used as a posterior hook and sacral/iliac screw fixation system, the levels of attachment are the lumbar and thoracic spine, and screw fixation limited to the sacrum and ilium. The System is intended for the treatment of degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). Psuedarthrosis; stenosis; scoliosis; spondylolisthesis, fracture; previous failed fusion; or tumor resection.

When used as an anterior fixation system, the levels of attachment are the anterolateral vertebral bodies of the lumbar and thoracic spine. The System is intended for the treatment of degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). Psuedarthrosis; stenosis; scoliosis; spondylolisthesis; fracture; previous failed fusion; or tumor resection.

The EBI SpineLink™ System is a spinal fixation device that uses interconnecting links. This submission is to revise the labeling in accordance with the FDA Final Rule dated July 27, 1998, "Orthopedic Devices: Classification and Reclassification of Pedicle Screw Spinal Systems."

The provided text does not describe the acceptance criteria or a study that proves the EBI SpineLink™ System meets acceptance criteria.

Instead, this document is a 510(k) Summary of Safety & Effectiveness for the EBI SpineLink™ System, which outlines the device's substantial equivalence to previously cleared devices. It focuses on:

1. Device Description and Intended Use: Detailing what the EBI SpineLink™ System is and the conditions it's intended to treat (spinal fixation for various instabilities and deformities).
2. Comparison to Predicate Devices: Stating that the device is substantially equivalent to other marketed spinal systems in terms of intended use, materials, and function, and complies with applicable standards and special controls.
3. Regulatory Information: Including the FDA's clearance letter for the device (K984027).

Therefore, I cannot populate the requested table or answer the specific questions about acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, ground truth, or MRMC studies, as this information is not present in the provided document.

The document does mention:

• Compliance with material standards.
• Compliance with mechanical testing standards.
• Compliance with biocompatibility standards.
• Labeling requirements.

These could be considered broad categories of "acceptance criteria," but no specific numerical or qualitative thresholds are provided, nor are any study results to demonstrate compliance.

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