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As a posterior, non-pedicle screw system of the T4-S2 spine, the Osteonics® Spinal System is indicated for:

• Long and short curve scoliosis .
• Vertebral fracture or dislocation
• . Spondylolisthesis
• . Degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies).
• Previously failed fusion
• . Spinal tumor

Pedicular Use:

• When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally . mature patients, the Osteonics Spinal System is indicated for one or more of the following: degenerative spondylolistlisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).
• In addition, the Osteonics Spinal system is indicated for pedicle screw fixation in skeletally . mature patients with severe spondylolisthesis (Grades 3 and 4) at the L5-S1 joint, having fusions with autogenous bone graft, having the device fixed or attached to the lumbar and sacral spine (with pedicle placement at L3 and below)with removal of the implants after the development of a solid fusion mass.

The Osteonics® Spinal System is comprised of single-use, non-sterile devices manufactured from ASTM F-136-96 Titanium Alloy (Ti6Al-4V ELI). The Osteonics® Spinal System consists of rods, hooks, containment rings, bone screws and their accessories (blockers and caps), and transverse links.

The provided document is a 510(k) Premarket Notification for the Osteonics® Spinal System. It seeks expanded indications for use, particularly concerning pedicle screw applications, due to a recent reclassification of such uses.

However, the document does not contain information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, or how ground truth was established, which are typically found in clinical trial reports or validation studies.

This document is primarily a regulatory submission for expanding the indications of an already cleared device, asserting substantial equivalence to the previously cleared version of the same device. It focuses on the scope of use rather than proving specific performance metrics through new studies.

Therefore, I cannot populate the requested table or provide details about the study because the provided text does not contain that information. The document explicitly states:

• "The Osteonics® Spinal System functions as the subject and predicate device. The components of the Osteonics® Spinal System were determined to be substantially equivalent via 510(k) #K951725."
• "The design and function of the Osteonics® Spinal System remains unchanged."
• "As a result of the recent downclassification of pedicle screw uses, the indications of the Osteonics® Spinal System will be expanded..."

These statements indicate that the submission is based on regulatory reclassification and previous substantial equivalence determinations, not on new performance studies for the expanded indications.

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