(88 days)
The Spinal Innovations SPECTRUM™ Cervical Spinal System is intended for anterior intervertebral body screw fixation of the cervical spine. The system implants are indicated for use in the temporary stabilization of the anterior spine during the development of cervical spine 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 or dislocation), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudoarthrosis, and/or failed previous fusions.
Warning: This device is not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.
The Spinal Innovations SPECTRUM™ Cervical Spinal System is intended for anterior intervertebral body screw fixation of the cervical spine. This system includes plates in varying designs and both fixed angle and variable angle screws. The screws are available in diameters of 4.0 mm and 4.5 mm and varying lengths. The plates have two widths: Standard width of .750 inches and Narrow width of .680 inches. The plates will be available in two lordotic curve geometries. The Cervical Screws are cancellous bone screws. The screw locking means is assembled to the plate during the manufacturing process.
The provided text is a 510(k) summary for the Spinal Innovations SPECTRUM™ Cervical Spinal System. It describes the device, its intended use, and the basis for substantial equivalence to predicate devices. However, this document does not contain information about acceptance criteria or a study proving the device meets specific acceptance criteria in the way one would expect for an AI/ML medical device.
This 510(k) is for a physical medical device (a cervical spinal system), not a software or AI/ML device. Therefore, the questions regarding AI/ML device performance (like stand-alone performance, MRMC studies, sample sizes for test/training sets, expert ground truth establishment, etc.) are not applicable to this type of submission.
The "Testing" section only states: "Biomechanical testing demonstrated that the components of the Spinal Innovations SPECTRUM™ Cervical Spinal System exhibit equivalent mechanical performance, compared to predicate devices." This implies that the acceptance criteria are related to mechanical performance equivalence, but the specific metrics, thresholds, or the details of the study are not provided in this summary.
Given the nature of the document, I cannot fulfill your request for information related to AI/ML device performance as it is not present. If you were looking for information on a physical medical device's performance, the provided text only offers a high-level statement about biomechanical 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.