(313 days)
The Dual Rod Anterior Fixator System is designed to aid in the surgical correction and stabilization of the spine. The system is intended to assist stabilization until a solid spinal fusion develops. The specific indications for the Dual Rod Anterior Fixator System are the following:
- Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies).
- Pseudoarthrosis
- Stenosis
- Spondylolisthesis
- Spinal deformities: scoliosis, kyphosis, lordosis
- Fracture
- Unsuccessful previous attempts at spinal fusion
- Tumor resection
All components of the Dual Rod Anterior Fixator System are intended to be fixed/attached to the anterolateral spine by bolts/prongs in the thoracic and/or lumbar areas only.
The Dual Rod Anterior Fixator System consists of the Dual Rod Fixator, transverse connector, bolts, and nut (DYNA-LOK® nut). Instrumentation is also available to facilitate implantation of the device components. The purpose of the Dual Rod Anterior Fixator System is to provide stabilization during the development of a solid spinal fusion. The Dual Rod Anterior Fixator System implant components are fabricated from ASTM F136 (or its ISO equivalent) titanium alloy or ASTM F138 (or its ISO equivalent) stainless steel and may be sold sterile or non-sterile. Titanium alloy implants are not to be used with stainless steel implant components in a spinal construct
The provided text is related to a 510(k) premarket notification for a medical device called the "Dual Rod Anterior Fixator System." This type of document is a regulatory submission to the FDA, not a study report that details acceptance criteria and device performance in the way a clinical trial or a performance study would. It focuses on demonstrating substantial equivalence to a predicate device rather than proving performance against specific acceptance criteria with detailed study results.
Therefore, the provided document does not contain the information required to populate a table of acceptance criteria and reported device performance, or to answer questions about sample size, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set details, or how ground truth was established for a training set.
The document states: "Mechanical test data were supplied in support of the Dual Rod Anterior Fixator V. System 510(k) notification. The Dual Rod Anterior Fixator System was declared to be substantially equivalent to several commercially available devices." This indicates that some mechanical testing was done, but the specifics of those tests, the acceptance criteria used, and the actual performance results are not included in this document.
Without the actual mechanical test report, it's impossible to provide the requested information.
§ 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.