(259 days)
The OAKTREE Anterior Lumbar Plate and Screw System is indicated for use via the anterior, lateral or anterolateral surgical approach above the bifurcation of the great vessels or via the anterior surgical approach, below the bifurcation of the great vessels as an adjunct to fusion. This system is indicated in the treatment of lumbar and lumbosacral (1-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 conformed by patient history and radiographic studies), pseudoarthrosis, spondylolysis, scoliosis, spondylolisthesis, lordotic deformities of the spine, spinal stenosis, or a failed previous spine surgery.
The OAKTREE Anterior Lumbar Plate and Screw System's implants are a Lumbar Plate System intended for use as an aid in spinal fixation. They are made of Titanium 6AL-4V Alloy (ASTM F136). The OAKTREE Anterior Lumbar Plate and Screw System consists of a variety of shapes and sizes of plates and screws. The plate has been designed to include spikes for added stability and alignment during screw insertion. The plates feature a curvature for anatomic fit. The diameter of the screw is available from 5.5 to 6.0 mm and the length from 20 to 55 mm.
The provided text describes a 510(k) premarket notification for the OAKTREE Anterior Lumbar Plate and Screw System. This is a medical device for spinal fixation and therefore, the acceptance criteria and study described relate to the mechanical performance of the device, not a software algorithm with a test set, training set, or expert ground truth.
Therefore, the following information is not applicable to this submission:
- Sample size used for the test set and data provenance
- Number of experts used to establish ground truth
- Adjudication method
- Multi-reader multi-case (MRMC) comparative effectiveness study
- Standalone (algorithm only) performance
- Type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Sample size for the training set
- How the ground truth for the training set was established
Here's the relevant information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The text states that the OAKTREE Anterior Lumbar Plate and Screw System was tested according to ASTM F 1717-18 and met all pre-defined acceptance criteria. While specific numerical acceptance criteria values are not provided, the reported performance is described as "equivalent mechanical value as predicate marketed devices."
| Acceptance Criteria Category | Standard | Reported Device Performance |
|---|---|---|
| Material Composition | ASTM F136 | Manufactured from Ti-6A1-4V ELI titanium alloy, same as predicate devices. |
| Mechanical Performance | ASTM F1717-18 | Demonstrated equivalent mechanical value to predicate marketed devices in: |
- Static Compression Bending
- Static Tension Bending
- Static Torsional
- Dynamic Compression Bending |
2. Study Proving Device Meets Acceptance Criteria
Type of Study: Bench testing to evaluate mechanical properties.
Tests Performed:
- Static Compression Bending Test - ASTM F1717-18
- Static Tension Bending Test - ASTM F1717-18
- Static Torsional Test - ASTM F1717-18
- Dynamic Compression Bending Test - ASTM F1717-18
Purpose of Study: To demonstrate substantial equivalency of the OAKTREE Anterior Lumbar Plate and Screw System to predicate devices.
Comparison: The subject device's mechanical values were compared to those of the predicate devices.
Conclusion: The bench testing showed that the OAKTREE Anterior Lumbar Plate and Screw System exhibited an equivalent mechanical value as predicate marketed devices and met all pre-defined acceptance criteria. The test results support the substantial equivalence claim.
§ 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.