(76 days)
Properly used, this system is intended for anterior interbody screw 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, lordosis, or scoliosis), 5) pseudarthrosis, and/or 6) failed previous fusions.
Nota Bene: This device system is intended for anterior cervical intervertebral body fusions only.
WARNING: This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.
The ATLANTIS™ Anterior Cervical Plate System consists of a variety of shapes and sizes of bone plates (set screws and washers are preassembled to the 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 allov described by ASTM F136 or ISO 5832-3. Stainless steel and titanium implant components must not be used together in a construct. MEDTRONIC SOFAMOR DANEK expressly warrants that these devices are fabricated from the foregoing material No other warranties, express or implied, are made. specification. Implied warranties of merchantability and fitness for a particular purpose or use are specifically excluded. Do not use any of the ATLANTIS™ Anterior Cervical Plate System components with the components from any other system or manufacturer.
This document is a 510(k) summary for the ATLANTIS™ Anterior Cervical Plate System, describing its substantial equivalence to itself. It is a regulatory submission for a medical device and therefore does not contain acceptance criteria for device performance nor a study proving it meets such criteria.
The prompt's request for specific information like sample sizes, data provenance, expert adjudication, MRMC studies, standalone performance, training set details, and ground truth establishment indicates a focus on clinical performance evaluation or AI/diagnostic algorithm validation. These are not typically part of a 510(k) submission for a spinal implant such as the ATLANTIS system.
A 510(k) application for a device like this primarily focuses on demonstrating that the new device is as safe and effective as a legally marketed predicate device. This is often achieved through material characterization, mechanical testing (e.g., fatigue, static strength), and comparison of design features and indications for use. The provided text indicates the ATLANTIS system was claimed to be substantially equivalent to itself, implying it's a modification or resubmission of an already cleared device, or perhaps a clarification of indications for an existing product line.
Therefore, I cannot fulfill the request for information regarding acceptance criteria and performance studies in the format requested because the provided document does not contain this type of data.
§ 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.