(136 days)
Properly used, this system is intended for anterior interbody screw/plate fixation of the cervical spine. The indications and contraindications of spinal instrumentation systems should be well understood by the surgeon. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with: 1) degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), 2) trauma (including fractures), 3) tumors, 4) deformity (defined as kyphosis, or scollosis), 5) pseudarthrosis, and/or 6) failed previous fusions.
The ATLANTIS® Anterior Cervical Plate System components are temporary implants that are intended for anterior interbody screw fixation of the cervical spine during the development of a cervical spinal fusion.
The ATLANTIS® Anterior Cervical Plate System consists of a variety of shapes and sizes of bone plates, screws, and associated instruments. Fixation is provided by bone screws inserted into the vertebral body of the cervical spine using an anterior approach.
The ATLANTIS® Anterior Cervical Plate System implant components are made from titanium alloy, with certain plates having subcomponents manufactured from a superelastic alloy (Nitinol-NiTi). Stainless steel and titanium implant components must not be used together in a construct.
The provided text describes a medical device, the ATLANTIS® Anterior Cervical Plate System, and its 510(k) submission to the FDA. The submission focuses on demonstrating substantial equivalence to previously marketed devices through mechanical testing. It does not contain information about acceptance criteria and studies related to AI/ML device performance.
Therefore, I cannot answer your specific questions related to acceptance criteria for an AI/ML device, its performance, sample sizes for test/training sets, expert qualifications, or ground truth establishment based on the provided text.
The document is a traditional 510(k) summary for a physical medical implant, not an AI/ML powered diagnostic or prognostic tool. The "study" mentioned is "Mechanical testing was provided demonstrating that the subject ATLANTIS® Translational Plate and subject screws are substantially equivalent to other commercially available anterior cervical fixation systems." This is a engineering/biomechanical study, not one evaluating 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.