(173 days)
The Blackstone Unity™ Anterior Lumbar Plate Fixation System is indicated for use as an anteriorly placed supplemental fixation device for the lumbosacral (LS-S1) level below the bifurcation of the vascular structures.
When properly used, this system will help provide temporary stabilization until a solid spinal fusion develops. Specific indications include:
- a) Degenerative disc disease (defined as back pain of discogenic origin with degenerative disc confirmed by history and radiographic studies)
- b) Pseudoarthrosis
- c) Spondylolysis
- d) Spondylolisthesis
- e) Fracture
- f) Neoplastic disease
- g) Unsuccessful previous fusion surgery
- h) Lordotic deformities of the spine
- i) Idiopathic thoracolumbar or lumbar scoliosis
- i) Deformity (i.e., scoliosis, and/or lordosis) associated with deficient posterior elements such as that resulting from laminectomy, spina bifida, or myelomenigocele
- k) Neuromuscular deformity (i.e., scoliosis, and/or kyphosis) associated with pelvic obliquity
The Blackstone Unity™ Anterior Lumbar Plate Fixation System is comprised of non-sterile, single use, titanium alloy components. The system is designed for use as a supplemental fixation device for the lumbosacral level, below the bifurcation of the vascular structures. The components are offered in a variety of sizes in order to accommodate specific needs during surgery.
I am sorry, but the provided text does not contain the information required to answer your request. The document describes a medical device (Blackstone™ Unity™ Anterior Lumbar Plate Fixation System) and its indications for use, as well as its substantial equivalence to a predicate device. However, it does not include any details about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or comparative effectiveness studies (MRMC, standalone). This document is a 510(k) summary for a spinal fixation device, which typically focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed performance study results in the manner you've described for AI/algorithm-based devices.
§ 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.