(72 days)
The Exactech Ambassador™ Cervical Plate System is intended for anterior cervical fixation (C2-T1) for the following indications: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e.. scoliosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.
The Ambassador™ Cervical Plate System consists of a variety of bone plates and screws. Fixation is achieved by inserting bone screws through the openings in the plate into the vertebral bodies of the cervical spine. The Ambassador™ Cervical Plate System implant components are made from titanium alloy such as described by ASTM F136. Plates and screws are provided nonsterile with instructions for sterilization.
I am sorry, but the provided text describes a medical device called "Exactech Ambassador™ Cervical Plate System" and its 510(k) premarket notification. This document focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and mechanical performance data, rather than acceptance criteria and a study proving device performance as typically understood for AI/ML-based medical devices.
Therefore, I cannot extract the information required in your request, such as a table of acceptance criteria and reported device performance (in the context of clinical metrics), sample sizes for test sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details. This type of information is usually associated with studies evaluating the diagnostic or predictive performance of algorithms, which is not the subject of this document.
§ 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.