(49 days)
Non-Pedicle Screw Fixation
When used as an anterior spinal system the Thoracolumbar Spinal Rod System is intended for the treatement of DDD (degenerative disc disease defined as back pain of discogenic origin with degeneration of the disc confirmed by history or radiographic studies), pseudoarthrosis, stenosis, deformities (scoliosis, kyphosis, lordosis), spondylolisthesis, fracture, previous failed fusion, or tumor resection. The Thoracolumbar Spinal Rod System is limited to non-cervical use.
When used as a posterior, non-pedicle spinal system (consisting of hooks and sacral/iliac screws), the Thoracolumbar Spinal Rod System is intended for the treatement of DDD (degenerative disc disease defined as back pain of discogenic origin with degeneration of the disc confirmed by history or radiographic studies), pseudoarthrosis, stenosis, deformities (scoliosis, kyphosis, lordosis), spondylolisthesis, fracture, previous failed fusion, or tumor resection. The Thoracolumbar Spinal Rod System is limited to non-cervical use.
Pedicle Screw Fixation
When used as a pedicle screw system, in the spine of skeletally mature patients, the Thoracolumbar Spinal Rod System is indicated for patients: (a) having severe spondylolisthesis (Grades 3 and 4) at the L5-S1 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.
In addition, when used as a pedicle screw system, in the non-cervical spine of skeletally mature patients, the Thoracolumbar Spinal Rod 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 of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).
The Thoracolumbar Spinal Rod System consists of stainless steel rods attached to the spinal column through the use of interlaminal hooks and/or screws. Crossbars may be used to connect rods to rods to provide a more rigid construct, as well as screws to rods and hooks to rods.
I am sorry, but the provided text does not contain information about acceptance criteria or a study proving device performance in the context of a medical device review. The document is a 510(k) premarket notification for a Thoracolumbar Spinal Rod System, primarily focusing on its intended use, device description, and substantial equivalence to predicate devices. It's a regulatory document for market clearance, not a performance study report.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance.
- Sample sizes or data provenance for a test set.
- Number and qualifications of experts for ground truth.
- Adjudication method.
- MRMC comparative effectiveness study results.
- Standalone algorithm performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.