(45 days)
The VIP™ Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine C2-C7 for the following indications: 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), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudarthrosis, failed previous fusion, spondylolisthesis, and spinal stenosis.
The VIP™ Anterior Cervical Plate System consists of plates of various lengths to be used with either variable angle screws or fixed angle screws. Each VIP plate attaches to the anterior portion of the vertebral body of the cervical spine (levels C2-C7). VIP™ implants are composed of titanium alloy, as specified in ASTM F136, F1295.
This document is a 510(k) Summary for the VIP™ Anterior Cervical Plate System, a medical device for spinal fixation. It describes the device, its intended use, and its substantial equivalence to predicate devices based on mechanical testing. However, it does not contain the information required to answer your questions about acceptance criteria and a study proving the device meets those criteria.
Here's why and what's missing:
- Acceptance Criteria and Reported Performance: The document states that "Mechanical testing in accordance with the 'Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s', May 3, 2004 is presented." This indicates that mechanical tests were performed, but the document does not report the specific acceptance criteria (e.g., minimum load to failure, maximum displacement under load) nor the actual results of these tests for the VIP system or its predicates.
- Study Details (Sample Size, Ground Truth, Experts, Adjudication, MRMC, Standalone): The document refers to "mechanical testing" – this is a physical bench test of the device, not a study involving human subjects, data analysis, or ground truth establishment in the way you're asking about (e.g., for an AI device). Therefore, none of the questions related to these aspects (sample size for test set, data provenance, number of experts, adjudication, MRMC, standalone performance, type of ground truth, training set details) are applicable or answerable from the provided text.
In summary, the provided text confirms that mechanical testing was performed to demonstrate substantial equivalence, but it does not detail the specific acceptance criteria, test results, or any clinical study information that would be relevant to the questions you've posed.
§ 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.