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The Kodiak Spinal Fixation System is intended for posterior, non-cervical fixation in skeletally mature patients as an adjunct to fusion for the following indications; degenerative discase (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e. Fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis and/or lordosis); tumor; pseudarthrosis; and/or failed previous fusion.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the Kodiak Spinal Fixation System implants are indicated as an adjunct to treat progressive spinal deformities (i.e., scoliosis, kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis. Additionally, the Kodiak Spinal Fixation System is intended to treat pediatic diagnosed with the following conditions: spondylolisthesis / spondylolysis. fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. Pediatic pedicle screw fixation is limited to a posterior approach.

The Kodiak Spinal Fixation System is intended to be used with autograft and/or allograft.

The Kodiak Spinal Fixation System is a thoracolumbosacral pedicle screw system designed to be implanted through a posterior surgical approach. The implants are manufactured from titanium alloy (Ti-6AI-4V ELI) per ASTM F136, commercially pure titanium (CP Ti Grade 2) per ASTM F67 and cobalt chromium (Co-28Cr-6Mo) alloy per ASTM F1537. The Kodiak System consists of a variety of shapes and sizes of screws, hooks, rods, connectors, and cross-connectors to create a rigid construct as an adjunct to fusion for temporary internal fixation and stabilization of the thoracic, lumbar and sacral spine.

The provided text is a 510(k) summary for the Kodiak Spinal Fixation System, a medical device for orthopedic surgery. It details the device's intended use, regulatory classification, and a comparison to predicate devices, focusing on non-clinical testing.

However, the document explicitly states: "Clinical Information: Not applicable; determination of substantial equivalence is not based on an assessment of clinical performance data."

This means that the 510(k) submission for the Kodiak Spinal Fixation System does not include a study proving the device meets acceptance criteria based on clinical performance or human-in-the-loop AI assistance. The "performance data" section only describes non-clinical mechanical testing (e.g., static and dynamic axial compression testing per ASTM F1717).

Therefore, I cannot provide the requested information regarding acceptance criteria and a study that proves the device meets those criteria, as no such clinical study data is presented or summarized in this 510(k) document. The device's substantial equivalence determination was based on non-clinical performance and a comparison of technological features to predicate devices.

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