(253 days)
The Quantum Anterior Cervical Plate is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion of the cervical spine (C2 to T1). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical fusion in patients with:
·degenerative disc disease (as defined by neck pain of discogenic origin with
degeneration of the disc confirmed by patient history and radiographic studies),
· spondylolisthesis,
- · trauma (i.e. fractures or dislocations),
- · tumors.
- · deformity (defined as kyphosis, lordosis, or scoliosis),
- · pseudarthrosis.
- · failed previous fusion,
- · spinal stenosis.
The Quantum Anterior Cervical Plate is a titanium alloy plate, conforming to ASTM F3001, intended for anterior screw fixation of the plate to the cervical spine. The fixation construct consists of a cervical plate that is attached to the vertebral body of the cervical spine with selfdrilling and self-tapping bone screws using an anterior approach. Plates are available in a variety of lengths (08 mm - 110 mm), addressing multiple levels of fixation (one to five). The plate incorporates graft visualization holes on the longitudinal center line for intraoperative visualization. Bone screws are available in three diameters (3.75 mm. and 4.75 mm) and a variety of lengths (10 mm - 20 mm). Screws are made from titanium alloy per ASTM F136.
This document is a 510(k) Premarket Notification from the U.S. Food & Drug Administration (FDA) for a medical device called the "Quantum Anterior Cervical Plate." It details the device's characteristics, intended use, and the rationale for its substantial equivalence to previously marketed predicate devices.
Based on the provided text, there is NO information regarding Acceptance Criteria or any study testing AI/ML-driven device performance. This document pertains to a physical medical implant (a cervical plate) and its mechanical testing, not a diagnostic or prognostic AI/ML system.
Therefore, I cannot provide the requested information as it is not present in the provided text. The questions posed in your prompt (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance) are relevant to the evaluation of AI/ML-based medical devices, which this document does not describe.
§ 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.