(24 days)
The uNion MAX Cervical Plate System is intended for anterior fixation of the cervical spine (C2 to T1). The system is to be used to provide stabilization of the anterior cervical spine as an adjunct to fusion for the treatment of 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), tumors, spinal stenosis, deformity (i.e., kyphosis, lordosis or scoliosis), pseudarthrosis or failed previous fusion.
uNion MAX is an anterior cervical plate and screw system used to provide mechanical support across implanted level(s) in the cervical spine until fusion is achieved. The components include Ø4.0mm and Ø4.5mm fixed and variable screws having self-tapping, self-drilling or self-drilling/self-tapping tips and one- through four-level plates having lengths from 8mm to 84mm. The plates incorporate a pivoting locking mechanism which functions to block screw backout. The devices are sold non-sterile.
The provided document is a 510(k) Premarket Notification from the FDA for a medical device called the uNion® MAX Cervical Plate System. It describes the device and its intended use, and importantly, declares that the device is "substantially equivalent" to legally marketed predicate devices based on performance data.
However, the document does not contain any information about acceptance criteria or a study that proves the device meets those criteria in the context of AI/ML performance. This document pertains to the regulatory clearance of a physical medical implant, not a software or AI-driven diagnostic or treatment device.
Therefore, I cannot provide the requested information. The concepts of "acceptance criteria," "reported device performance," "sample size for test set," "data provenance," "experts to establish ground truth," "adjudication method," "MRMC study," "standalone performance," "type of ground truth," "sample size for training set," and "ground truth for training set" as typically applied to AI/ML devices, are not applicable to this document.
The "Performance Data" section in the 510(k) summary refers to "ASTM F1717 mechanical testing of the worst case uNion MAX constructs included static and dynamic compression bending and static torsion." This testing is for the mechanical properties of the cervical plate system itself, ensuring its structural integrity and safety. It tests the physical attributes of the device, not its analytical or interpretive capabilities.
§ 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.