(17 days)
The C-TEK Anterior Cervical Plate System is intended for anterior interbody screw fixation of the cervical spine. This system is indicated for use in the temporary stabilization of the anterior spine from C2 to C2 during the development of cervical spinal fusions in patients with: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies); trauma (including fractures); primary and metastatic malignant tumors; deformity (defined as kyphosis, or scoliosis); pseudarthrosis; failed previous fusions; and/or spinal cord stenosis and cervical myelopathy.
The INTERPORE CROSS C-TEK C-Thru Anterior Cervical Plate System is intended for anterior interbody screw fixation of the cervical spine. This system is indicated for use in the temporary stabilization of the anterior spine from C2 to C7 during the development of cervical spinal fusions in patients with: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies); trauma (including fractures); primary and metastatic malignant tumors; deformity (defined as kyphosis, lordosis, or scoliosis); pseudarthrosis; failed previous fusions; and/or spinal cord stenosis and cervical myelopathy.
The C-TEK Anterior Cervical Plate System consists of a variety of shapes and sizes of bone plates and screws manufactured from surgical implant grade titanium alloy as described by ASTM F 136 (Ti 6Al 4V ELI). The plates are provided in a fixed hole (C-TEK and C-TEK C-Thru) or slotted hole (C-TEK) design and are available in 1 to 5 level plates. The screws are supplied color coded to identify their respective lengths. Fixation is provided by bone screws inserted into the vertebral body of the cervical spine using an anterior approach.
The provided document is a 510(k) summary for a medical device called the "C-TEK Anterior Cervical Plate System." This filing focuses on establishing substantial equivalence to a predicate device, primarily through material composition, indications for use, and biomechanical performance. It does not describe a study involving an AI/algorithmic device or its performance against acceptance criteria in the manner requested.
The questions in your prompt are geared towards evaluating an AI-powered diagnostic or assistive device, which requires details about:
- Statistical performance metrics (sensitivity, specificity, accuracy).
- Test and training datasets (size, provenance, ground truth establishment).
- Expert involvement (number, qualifications, adjudication).
- Comparative effectiveness studies (MRMC, standalone).
Since the C-TEK Anterior Cervical Plate System is a physical implant (spinal intervertebral body fixation orthosis) made of titanium alloy, these types of evaluations are not applicable. The substantial equivalence for this device would be demonstrated through mechanical testing (e.g., fatigue, static strength), biocompatibility, and sterilization validations, rather than diagnostic performance metrics against a medical imaging dataset.
Therefore, I cannot fulfill your request as the provided text does not contain the information necessary to describe acceptance criteria or a study proving device performance for an AI/algorithmic device. The document is about a hardware medical implant.
§ 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.