(67 days)
The Trinica Select™ Anterior Cervical Plate System is intended for anterior interbody screw fixation of the cervical spine at levels C2-T1. The System is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with degenerative disc disease (as defined by neck pain of discogenic origin of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudoarthrosis, and/or failed previous fusions.
WARNING: This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.
The Trinica Select Anterior Cervical Plate System is a fixation device consisting of cervical plates, locking caps, fixed bone screws and variable angle bone screws made from titanium alloy in conformance with ASTM F136. The locking cap is preassembled onto the plate and is designed with tabs that prevent bone screws from backing out. The plates and locking caps are treated with titanium anodization per AMS (Aerospace Material Specification) 2488 Type II. Bone screws are subjected to a color anodizing process to differentiate the screw type and diameter
Plates are offered in one-level, two-level, and four-level fusion configurations (22 mm through 92 mm). Bone screws are available in lengths from 10mm through 18mm in 1mm increments. The screws have either a 4.2 inch 4.6 inch diameter. Fixed angle and variable angle screws are available.
The provided document is a 510(k) summary for the Trinica Select Anterior Cervical Plate System. It describes a medical device and its substantial equivalence to predicate devices, rather than a study evaluating device performance against acceptance criteria for an AI/ML powered device. Therefore, the requested information regarding acceptance criteria, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies is not available in this document.
The document states:
- Summary of Non-Clinical Tests: "Based on risk analysis, appropriate testing was conducted to evaluate the impact of the changes to ensure that the modified device meets established criteria and that identified potential risks were mitigated. Results of the testing demonstrated that the modified device meets established criteria."
- Conclusions Drawn From Testing: "Testing of the Trinica Select Anterior Cervical Plate System demonstrates that the device is substantially equivalent to the devices and that the design modifications do not affect device safety and effectiveness."
However, it does not specify what these established criteria are, what the reported device performance was against these criteria, or provide any details about the study design that would allow me to populate the requested table and answer the specific questions about sample sizes, ground truth, experts, or comparative effectiveness.
This document focuses on demonstrating substantial equivalence for a physical medical device (an anterior cervical plate system) based on material, design, and non-clinical performance testing (likely mechanical testing under loads), rather than clinical performance or the performance of an AI/ML algorithm.
§ 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.