(298 days)
The VerteLoc Spinal System is indicated for use as a cervical vertebral body replacement (VBR) fusion device in the cervical spine (C3-C7) in skeletally mature patients for partial or total replacement of diseased, collapsed or unstable vertebral body due to tumour, trauma (i.e., fracture), or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues.
The VerteLoc Spinal System is to be used with bone graft material. The Vertel.oc Spinal System is intended for use with supplemental internal fixation that has been cleared by the FDA.
The Verteloc Spinal System is a modular vertebral body replacement (VBR) system intended to replace a diseased, collapsed, damaged or unstable cervical vertebral body following partial or total corpectomy. The VerteLoc device comprise of three components; two end bodies and one mid body, which when used in combination is used to replace a measured deficit in the patient's spine. The VerteLoc device is offered in a variety of footprints and heights to accommodate the needs of patients. When assembled, the central portion of the end and mid bodies create an inner hollow for the placement of autograft and/or autograft bone graft material. The VerteLoc device is manufactured from unreinforced PEEK OPTIMA LT1 as per ASTM F2026 with titanium pins as per ASTM F136 and ISO 5832-3 as well as tantalum marker beads as per ASTM F560 and ISO 13782.
The VerteLoc Spinal System VBR is to be used in conjunction with supplemental fixation systems.
I am sorry, but the provided text does not contain information about the acceptance criteria or a study proving that a device meets the acceptance criteria. The document is an FDA 510(k) clearance letter for the "VerteLoc Spinal System," which describes the device, its indications for use, and a summary of technological characteristics compared to predicate devices. It also mentions non-clinical testing conducted, but it does not detail specific acceptance criteria, reported device performance against those criteria, or the methodology of an in-depth study to prove acceptance.
Therefore, I cannot provide the requested table or answer the specific questions about sample size, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth establishment, or training set details.
§ 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.