(111 days)
Properly used, this system is interior interbody screw fixation of the cervical spine. The indications and contraindications of spinal instrumentation systems should be well understood by the surgeon. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with: 1) degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), 2) trauma (including fractures), 3) tumors, 4) deformity (defined as kyphosis, lordosis, or scoliosis), 5) pseudarthrosis, and/or 6) failed previous fusions.
Nota Bene: This device system is intended for anterior cervical intervertebral body fusions only.
WARNING: This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.
The PREMIER™ Anterior Cervical Plate System consists of a variety of bone plates and screws. Fixation is achieved by inserting bone screws through the openings in the plate into the vertebral bodies of the cervical spine. The PREMIER™ Anterior Cervical Plate System features a sliding washer that covers the heads of the bone screws to prevent screw back-out. The sliding washer is fixed into place with a set screw. The sliding washer and set screw come pre-assembled to the plate. Associated instruments are available to facilitate the implantation of the device.
The PREMIER™ Anterior Cervical Plate System implant components are made from titanium alloy such as described by ASTM F136 or ISO 5832-3. This material is not compatible with other metal alloys. Do not use any of the PREMIER™ Anterior Cervical Plate System components with the components from any other system or manufacturer. MEDTRONIC SOFAMOR DANEK expressly warrants that these devices are fabricated from the foregoing material specifications. No other warranties, express or implied, are made. Implied warranties of merchantability and fitness for a particular purpose or use are specifically excluded.
The provided text is a 510(k) summary for the PREMIER™ Anterior Cervical Plate System. It describes the device, its indications for use, and a substantial equivalence claim to itself. However, it does not contain any information about acceptance criteria, device performance testing, clinical studies, sample sizes, ground truth establishment, or expert reviews.
Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, as this information is not present in the provided document.
The document only states:
- Device Name: PREMIER™ Anterior Cervical Plate System
- Description: A system of bone plates and screws for anterior interbody screw fixation of the cervical spine, featuring a sliding washer to prevent screw back-out. Made from titanium alloy.
- Indications for Use: Temporary stabilization of the anterior spine during cervical spinal fusions in patients with degenerative disc disease, trauma, tumors, deformity, pseudarthrosis, and/or failed previous fusions.
- Substantial Equivalence: Claimed to be substantially equivalent to itself, implying it's a modification or resubmission of a previously cleared device, or that the previous predicate was also this same device. This typically means performance testing against specific criteria would have been done for the original device or is considered sufficiently similar to not warrant new, extensive clinical trials for this resubmission.
To answer your specific questions, information regarding performance testing and acceptance criteria would typically be found in a separate section of a 510(k) submission, not usually included in the public 510(k) summary provided here.
§ 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.