(86 days)
The AcroMed Anterior Cervical Stabilization System is intended for anterior cervical intervertebral body fixation. This system is indicated for patients in which stability is desired following anterior cervical fusion for the indications listed below. The intended levels for treatment range from C2 to T1.
Indications include symptomatic cervical spondylosis, trauma (including fracture), post-traumatic kyphosis or lordosis, tumor, degenerative disc disease (defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies), re-operation for failed fusion, or instability following surgery for the above indications.
The AcroMed Anterior Cervical Stabilization System, in its fully assembled form, consists of two laterally placed rods joined by platforms which lie on the anterior vertebral surface. The system is anchored to the vertebrae with screws. The implant provides supplemental stability to the cervical spine following anterior cervical fusion. Depending upon the implant configuration, it may serve as either a fixed (load-bearing) or unfixed (load-sharing) construct.
The following types of components are available in the system: Rods, Platforms, Screws and Cross Connectors. All components are manufactured from implant grade Titanium alloy which conforms to ASTM F136 specifications. Assemblies are also available for convenience of the surgeon. These are pre-assembled partial constructs consisting of one Platform, one Cross Connector, two Rods and two Locking Screws.
An instrument set is available specifically designed for use with the AcroMed Anterior Cervical Stabilization System.
The provided text describes a medical device, the AcroMed Anterior Cervical Stabilization System, and its 510(k) submission for market clearance. However, it does not contain information about acceptance criteria, device performance studies, sample sizes, expert involvement, or any of the detailed study parameters requested.
The document states: "PERFORMANCE DATA: Non-Clinical: Static bending compression and torsion were performed on the system to characterize its mechanical properties. Additionally, testing was also performed to characterize fatigue life. Finally, quasi-static range-of-motion studies were performed in axial compression/tension and torsion to characterize the system's displacement during loading."
This section only broadly mentions the types of non-clinical mechanical tests conducted. It does not provide any specific criteria for these tests, the actual results obtained, or any details about how these results demonstrate that the device meets some predefined acceptance criteria. It also does not discuss any clinical studies.
Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance or any of the other detailed study parameters, as this information is not present in the provided text.
§ 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.