(45 days)
The Raven Lumbar Plate System Anterior and Lateral Plates are indicated for use via a lateral or anterolateral surgical approach above the bifurcation of the great vessels in the thoracic and thoracolumbar (TI-LS) spine or via an anterior approach below the bifurcation of the great vessels in the treatment of lumbar and lumbosacral (L1-S1) spine. The system is intended to provide additional support during fusion in skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities:
· Degenerative Disc Disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies);
- · Pseudoarthrosis;
- · Spondylolysis;
- · Spondylolisthesis:
- · Spinal stenosis;
- Tumors;
- · Trauma (i.e. Fractures or Dislocation);
- · Deformities (i.e. Scoliosis, Kyphosis or Lordosis);
- Failed Previous Fusion
The Raven Lumbar Plate System Buttress Plate is intended to stabilize the allograft at one level (T1-S1) as an aid to spinal fusion and to provide temporary stabilization and augment of a solid spinal fusion. It may be used alone or with other anterior, anterolateral, or posterior spinal systems made of compatible materials. This device is not intended for load bearing applications.
Raven Lumbar Plate System is an anterior/anterolateral/lateral plate system that may be used in the thoracic, lumbar, and sacral spine (T1-S1). Raven Lumbar Plate System consists of plates and screws manufactured from titanium alloy (Ti-6Al-4V ELI) per ASTM F136, as well as associated manual general surgical instrumentation. The implants are available in a variety of sizes to accommodate various patient anatomies.
The provided text is a 510(k) summary for the Raven Lumbar Plate System, a spinal intervertebral body fixation orthosis. It primarily describes the device, its indications for use, and its substantial equivalence to predicate devices through a risk analysis and mechanical testing.
Crucially, this document does not contain information about the performance of a software algorithm or AI device. The acceptance criteria mentioned refer to mechanical testing of the physical implant (Static and dynamic compression testing per ASTM F1717-15, and Static torsion testing per ASTM F1717-15), not the performance of a device that uses data, ground truth, or human experts as described in your request.
Therefore, I cannot extract the information required in your prompt based on the provided text. The prompt asks for details pertaining to the rigorous evaluation of a software or AI device, including aspects like sample size for test and training sets, expert adjudication, MRMC studies, and ground truth establishment. None of these concepts are addressed in the provided FDA 510(k) letter for a physical orthopedic implant.
If you have a document describing the evaluation of a medical device that is a software or AI product, please provide that text, and I will do my best to answer your questions.
§ 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.