Search Results

The ISOBAR Spinal System is a pedicle screw system intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

As a pedicle screw system, the ISOBAR Spinal System is intended for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebrae in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

When used as a posterior, non-cervical, non-pedicle screw fixation system, the ISOBAR Spinal System is intended for hook fixation from T1 to the ilium/sacrum. The non-pedicle screw indications are spondylolisthesis, degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by history patient history and radiographic studies), deformities (scoliosis, kyphosis and lordosis), tumor, pseudoarthrosis, trauma (fracture or dislocation) and/or previous failed fusion surgery.

The ISOBAR Spinal System consists of pedicle screws, rods, nuts, crosslink members and hooks. It can be used for single or multiple level fixation. All components are manufactured from titanium alloy (Ti-6A1-4V) that conforms to ASTM F136.

The provided text describes the ISOBAR Spinal System and its substantial equivalence to predicate devices, but it does not contain information related to software or AI-based device performance, acceptance criteria, or a study to prove acceptance criteria.

The device in question is a physical pedicle screw spinal system, and its performance data is limited to "static and fatigue compression testing... according to ASTM F1717-96." This is a standard for mechanical testing of metallic spinal implant constructs, not for evaluating algorithm performance or clinical accuracy.

Therefore, I cannot provide the requested information about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth for an AI/software device, as these aspects are not applicable to the presented documentation for the ISOBAR Spinal System.

Ask a specific question about this device