(79 days)
Synthes Vectra-T System is intended for anterior plate and screw fixation of the cervical spine (C2-C7).
Synthes Vectra-T System is indicated for the following:
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., fractures or dislocations)
Spinal Stenosis
Tumors (primary and metastatic)
Failed previous fusions
Pseudoarthrosis
Deformity (i.e., scoliosis, kyphosis, and/or lordosis)
The Synthes Vectra-T System consists of one-level to four-level plates with cancellous and cortex fixed-angle and variable-angle screws. The plate attaches to the anterior portion of the vertebral body of the cervical spine (C2-C7). The plate uses a translating mechanism for the screw carriage to slide to accommodate for bone graft resorption. There is a removable spacer that holds the screw carriage in place during screw placement.
The plates and screws are manufactured from Titanium Aluminum Niobium (Ti-6Al-7Nb), the same as K050451 Vectra System. The plate clip is manufactured from Elgiloy (40Co-20Cr-16Fe-15Ni-7Mo), the same as K050451 Vectra System.
The provided text is a 510(k) summary for the Synthes Vectra-T System, a cervical plating instrumentation. This type of regulatory document is for medical devices and does not typically include clinical study data in the way that an AI/software as a medical device (SaMD) submission would.
Therefore, the information required to answer the questions about acceptance criteria and study details (such as sample size, data provenance, ground truth, expert qualifications, adjudication methods, MRMC studies, or standalone performance for an algorithm) is not present in the provided document.
The document describes the device, its intended use, and its substantial equivalence to previously cleared devices. It focuses on the physical characteristics and indications for use, not on the performance of a diagnostic algorithm or AI system.
Based on the provided text, I cannot provide the requested information.
§ 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.