(21 days)
The MiRus MoRe Lumbar Plating System is indicated for use via lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of the thoracic and thoracolumbar (T1-L5) 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 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 MiRus MoRe Lumbar Plating System is a spinal intervertebral body fixation orthosis intended to provide structural stability and mechanical support to the lumbar spine following lumbar interbody fusion.
The MiRus MoRe Lumbar Plating System consists of implants manufactured from Molybdenum-47.5 Rhenium Alloy (MoRe) per ASTM F3273, screws and locking cam mechanism manufactured from Titanium-6 Vanadium ELI per ASTM F136, and instrumentation manufactured from Stainless Steel per ASTM F899. The MiRus MoRe Lumbar Plating System implants are offered in multiple configurations and different sizes to accommodate various patient anatomical requirements: ANTARES" Anterior Lumbar Plate and MiRus Lateral Lumbar Plate.
The plates are provided sterile packed and are intended for single use only. The screws must be steam sterilized prior to use.
The provided text describes a medical device, the "MiRus MoRe Lumbar Plating System," which is a spinal intervertebral body fixation orthosis. However, this document does not contain information about an AI/ML-driven medical device, nor does it provide details about acceptance criteria and studies for an AI/ML device's performance.
The document focuses on the regulatory clearance (510(k)) of a physical medical implant and its mechanical performance, comparing it against established ASTM standards and FDA guidance for spinal plating systems. The testing described is non-clinical mechanical testing (static and dynamic compression bending, static torsion) and does not involve AI/ML performance metrics, human readers, ground truth establishment through expert consensus or pathology, or training/test sets for an algorithm.
Therefore, I cannot provide the requested information regarding acceptance criteria and the study that proves an AI/ML device meets these criteria based on the provided text. The questions posed in your prompt (e.g., sample size for test/training sets, number of experts for ground truth, MRMC study, standalone performance) are relevant to AI/ML device evaluation, but the provided document is for a traditional medical device (implant).
§ 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.