(89 days)
The R&B Surgical Solutions SmartPlate™ Cervical Plate System is intended for anterior screw fixation of the cervical spine and is designed to provide stabilization as an adjunct to spinal fusion at these levels. Indications for the use of this device include failed previous fusion, pseudarthrosis, tumor, deformity, spinal stenosis, trauma, spondylolisthesis or degenerative disc disease defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies.
The R&B Surgical Solutions SmartPlate™ Cervical Plate System consists of plates, screws and screw-retaining covers. The device, as a system, is designed to provide stabilization as an adjunct to cervical fusion.
The provided document is a 510(k) summary for the R&B Surgical Solutions SmartPlate™ Cervical Plate System. It describes the device, its intended use, materials, and substantial equivalence to previously cleared devices. However, this document does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria.
The 510(k) summary explicitly states: "Documentation was provided which demonstrated the SmartPlate™ Cervical Plate System to be substantially equivalent to previously cleared devices. The substantial equivalence is based upon equivalence in indications for use, anatomic sites, performance and material of manufacture."
This means that the device was cleared based on its similarity to existing, legally marketed devices, rather than through a new clinical performance study demonstrating specific acceptance criteria with metrics like sensitivity, specificity, or accuracy.
Therefore, I cannot provide the requested information regarding:
- A table of acceptance criteria and the reported device performance: This information is not present in the document.
- Sample size used for the test set and the data provenance: Not applicable as no dedicated performance study is described.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used: Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
The clearance is based on substantial equivalence, which is a regulatory pathway that does not typically require new clinical performance studies demonstrating specific quantitative performance metrics when compared to a predicate device.
§ 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.