(9 days)
The Struxxure® System is intended for anterior screw fixation of the cervical spine. These implants have been designed to provide stabilization as an adjunct to cervical fusion. Indications for the use of this implant system include degenerative disc disease (defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), spinal stenosis, deformity (i.e., kyphosis, lordosis or scoliosis), tumor, pseudarthrosis or failed previous fusion.
Struxxure consists of plates and screws in a variety of sizes. Plates from 1- to 5-levels are offered. Fixed and variable angle screws are available in two diameters in both self-drilling versions. This submission adds additional 1-level plate options to the Struxxure Anterior Cervical Plate System.
The provided document is a 510(k) Premarket Notification from the FDA for a medical device called the "STRUXXURE® MCS Anterior Cervical Plate System." This document primarily focuses on demonstrating substantial equivalence to a predicate device based on mechanical testing and a comparison of intended use, indications for use, basic design, and materials.
Crucially, this document does NOT describe the performance of software or an AI-powered device, nor does it detail a clinical study involving human readers or the establishment of ground truth for such a device. The acceptance criteria and study information requested in your prompt (related to AI/software performance) are not applicable to the content provided.
The document discusses:
- Device: STRUXXURE® MCS Anterior Cervical Plate System, which is an implantable medical device (plates and screws) for anterior cervical spinal fixation.
- Purpose of Submission: To demonstrate substantial equivalence to a legally marketed predicate device (STRUXXURE® Anterior Cervical Plate System) to allow the new device to be marketed.
- Testing: Mechanical tests were performed on the "worst case subject plate per ASTM F1717: static compression bending, static torsion, and dynamic compression bending."
- Conclusion: The tests demonstrated "substantially equivalent mechanical performance of the subject plates as compared to legally marketed predicates."
Therefore, I cannot provide the information requested in your prompt using the provided text because it does not pertain to the performance of a software or AI device. The document is about the physical characteristics and mechanical performance of a spinal 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.