(70 days)
The intended use of the SIMAL Cervical Stabilization Device is anterior screw fixation of the cervical spine. Fixation is done via ventral or transoral approach. Indications for Use: Spondylolisthesis(instability), fractures, spinal stenosis, deformities (scoliosis, kyphosis, lordosis), tumors, or pseudarthrosis
The SIMAL Cervical Stabilization System are screws and plates for anterior stabilization of the cervical spine and for anterior C2. C1 stabilization from the transoral approach.
The anterior stabilization plates have large length varieties with four lengths per segment to fit all patient sizes. For the Trans-oral approach "winged" models secure placement of articular grafts.
Both of the types of plates are anchored by titanium screws, which are available in various sizes.
The provided text is a 510(k) summary for the SIMAL Cervical Stabilization System. It describes the device, its intended use, and its equivalence to previously marketed devices. However, this document does not contain any information about acceptance criteria, device performance testing, study design elements (like sample size, ground truth, expert qualifications, or adjudication methods), or any comparative effectiveness studies (MRMC) or standalone algorithm performance.
The 510(k) summary is a premarket notification to the FDA to demonstrate that a device is substantially equivalent to a legally marketed predicate device. It primarily focuses on comparing technological characteristics and intended use, not on presenting detailed performance data from studies against specific acceptance criteria in the way a clinical trial or performance evaluation report would.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. The document simply states the device is substantially equivalent to predicate devices, implying it meets established safety and effectiveness standards by virtue of that equivalence.
§ 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.