(56 days)
The Meridian Anterior Plate System is indicated as additional support during fusion via an anterior or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracic and thoracolumbar (T1-L5) spine instability or via the anterior surgical approach, below the bifurcation of the great vessels in the treatment of lumbar and lumbosacral (L1-S1) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, kyphosis, spinal stenosis, or a failed previous spine surgery.
The SeaSpine Regatta Lateral Plate System is indicated as additional support during fusion via a lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracolumbar (T) -L5) spine instability or via a lateral or anterolateral surgical approach below the bifurcation of the treatment of lumbar and lumbosacral (L1-S1) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, lordosis, spinal stenosis, or a failed previous spine surgery.
The Meridian Anterior Plate and Regatta Lateral Plate Systems each consist of varying sizes of plates and fixation options that accommodate either anterior or lateral surgical approaches in the thoracic, lumbar, and sacral spine (T1-S1). Each plate is manufactured from titanium alloy per ASTM F136 and is designed to provide additional support during spinal fusion procedures.
The provided text is an FDA 510(k) clearance letter and summary for a spinal plate system. It details the device's indications for use, its classification, and a comparison to predicate devices, including the non-clinical testing performed.
However, the document does not describe an AI medical device or a study proving an AI device meets acceptance criteria. It lacks any information regarding:
- Acceptance criteria for an AI device.
- Performance metrics (e.g., sensitivity, specificity, AUC) for an AI device.
- Sample sizes for test sets or training sets for an AI model.
- Data provenance for AI model development.
- Expert involvement in establishing ground truth for AI.
- Adjudication methods.
- Multi-reader multi-case (MRMC) studies or human-in-the-loop performance.
- Standalone AI performance.
- Ground truth types (pathology, outcomes data, etc.) for AI.
Therefore, I cannot extract the requested information as it is not present in the provided text.
The document explicitly states the testing performed:
- Static Compression Bending (ASTM F1717)
- Static Torsion (ASTM F1717)
- Dynamic Compression Bending (ASTM F1717)
These are mechanical and physical performance tests for an orthopedic implant, not an AI diagnostic or assistance device. The conclusion states "Minor differences in non-clinical test results do not impact device performance when compared to the legally marketed predicate devices," which further confirms the focus on mechanical equivalence.
§ 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.