(80 days)
The Synthes Oracle Plate is indicated for use, via the 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 (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), pseudoarthrosis, spondylolysis, spondylolisthesis, scoliosis, lordotic deformities of the spine, spinal stenosis, or failed previous fusion.
The Synthes Oracle Plate is an addition to Synthes' existing anterior/anterolateral/lateral thoracolumbar spine systems. The Oracle Plate implant consists of a plate and 4 bone screws, all manufactured from Titanium Aluminum Niobium (Ti-6Al-7Nb) ASTM F1295, the same material as the predicates.
The acceptance criteria and study proving the device meets them are described below:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Non-Clinical: Substantial equivalence to predicate devices based on design, function, material, and intended use. | Bench testing results demonstrate that the Synthes Oracle Plate System is substantially equivalent to the predicate devices. |
| Clinical: Not required. | Clinical data and conclusions were not needed for this device. |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not applicable. The submission states "Clinical data and conclusions were not needed for this device." The non-clinical performance relied on bench testing, for which sample sizes are not provided in this summary.
- Data Provenance: Not applicable. Clinical data was not required or provided. For non-clinical bench testing, the provenance of materials or components used in testing is not detailed, but it would typically be from the manufacturer's internal processes.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. Clinical ground truth was not established as clinical data was not required. For non-clinical bench testing, the "ground truth" would be engineering specifications and standards, verified by engineers or technicians. The number and qualifications of individuals involved in the bench testing are not provided.
4. Adjudication method for the test set:
Not applicable. No human adjudication method for a test set is mentioned, as clinical data was not required.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This device is a spinal implant system, not an AI-assisted diagnostic or imaging device. Therefore, an MRMC study is not relevant, nor is the concept of human readers improving with AI assistance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a physical spinal implant system and does not involve an algorithm or AI.
7. The type of ground truth used:
- For Non-Clinical Performance: The ground truth for the non-clinical performance was based on engineering specifications, material properties (Titanium Aluminum Niobium (Ti-6Al-7Nb) ASTM F1295), and the functional performance criteria established for substantial equivalence to predicate devices. This is assessed via bench testing.
- For Clinical Performance: Not applicable, as clinical data was not required.
8. The sample size for the training set:
Not applicable. This device is a physical spinal implant system and does not involve AI or machine learning models that require a training set.
9. How the ground truth for the training set was established:
Not applicable. As noted above, this device does not involve AI or machine learning and therefore does not have a "training set."
§ 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.