(64 days)
The Uniplate Anterior Cervical Plate 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.
Indication includes symptomatic cervical spondylosis, trauma, 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), spinal stenosis, re-operation for failed fusion, or instability following surgery for the above indications.
Uniplate Anterior Cervical Plate System consists of an assortment of plates and screws.
The Uniplate Anterior Cervical Plate System also contains Class 1 manual surgical instruments and cases that are considered exempt from premarket notification.
This 510(k) summary describes a spinal implant device, not a device that measures or reports performance metrics like accuracy, sensitivity, or specificity. Therefore, the information requested in the prompt (acceptance criteria, study details, human reader improvement, etc.) is not applicable to this submission.
The document focuses on demonstrating substantial equivalence to a predicate device based on design, materials, and intended use, rather than on performance metrics obtained from human subject studies or algorithmic evaluations.
Here's why the specific questions cannot be answered from the provided text:
- No reported performance data: The "PERFORMANCE DATA:" section states "Performance data were submitted to characterize the Uniplate Anterior Cervical Plate System" but does not provide any specific metrics or results. This is common for mechanical devices where testing often involves benchtop mechanical evaluations rather than clinical performance metrics.
- No AI/Algorithm component: The device is a physical spinal implant (plates and screws). It does not involve any artificial intelligence, algorithms, or image interpretation components that would require a test set, ground truth, expert consensus, or MRMC studies.
- Nature of the device: This is a Class II medical device, specifically a "Spinal Intervertebral Body Fixation Orthosis." The regulatory pathway for such devices often involves demonstrating mechanical performance and biocompatibility, along with substantial equivalence to a legally marketed predicate device, rather than diagnostic accuracy.
Therefore, a table of acceptance criteria and reported device performance with the requested details cannot be generated from the given 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.