(71 days)
The SEEplate Cervical Plate System is intended for anterior screw fixation at the vertebral bodies of the cervical spine (C2-C7). The SEEplate Cervical Plate System is indicated for use in temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with degenerative disc disease (as defined by neck pain in discogenic origin of the disc confirmed by patient history and radiographic studies), spinal stenosis, spondylolisthesis, deformity (defined as kyphosis, and scoliosis), trauma (including fractures), tumors, pseudoarthrosis, and/or failed previous fusions.
This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine. The device is intended for anterior cervical intervertebral body fusions only.
The SEEplate Cervical Plate System is comprised of an assortment of titanium alloy plates and screws that act to stabilize the spine during the intervertebral fusion process. The SEEplate Cervical Plate System is manufactured from wrought Ti-6Al-4V in accordance with ISO 5832-3.
The provided text describes a 510(k) premarket notification for the Amedica SEEplate Cervical Plate System. This is a medical device for spinal fixation, and the documentation pertains to its substantial equivalence to a predicate device, not to its performance against specific acceptance criteria in a clinical study as would be seen for AI/ML devices or novel therapies.
Therefore, many of the requested categories are not applicable to this type of device submission. The submission relies on establishing substantial equivalence to a legally marketed predicate device rather than presenting performance data from a clinical study with detailed acceptance criteria.
Here's an analysis based on the provided text, addressing the points where information is available or indicating when it's not applicable:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Device | The SEEplate Cervical Plate System was shown to be substantially equivalent to the Amedica Valeo Cervical Plate System (K071990). |
| Indications for Use | Same indications for use as the predicate device. |
| Design | Same design as the predicate device. |
| Function | Same function as the predicate device. |
| Materials Used | Same materials used (wrought Ti-6Al-4V in accordance with ISO 5832-3) as the predicate device. |
| Performance Standards | Testing performed indicates the subject device is substantially equivalent to predicate devices. (Specific performance parameters or numerical criteria are not detailed in this summary.) |
Explanation: The acceptance criteria for this 510(k) clearance are primarily based on demonstrating "substantial equivalence" to a predicate device (Amedica Valeo Cervical Plate System, K071990) across key attributes: indications for use, design, function, and materials. The document states that "Testing performed indicates the subject device is substantially equivalent to predicate devices," implying that any relevant performance standards (likely mechanical and biocompatibility tests for an implantable device) were met to support this claim, but the specific numerical acceptance criteria or detailed results are not included in this summary.
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. This 510(k) summary does not describe a clinical study with a test set of data. The "testing performed" mentioned refers to non-clinical performance standards to demonstrate equivalence.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This is not a study requiring expert-established ground truth for a test set.
4. Adjudication Method for the Test Set
Not applicable.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This type of study is typically done for diagnostic imaging devices or AI tools assisting human interpretation, not for an implantable cervical plate system seeking 510(k) clearance based on substantial equivalence.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. This is not an AI/ML algorithm or diagnostic tool.
7. Type of Ground Truth Used
Not applicable in the context of data for an AI/ML algorithm. For this device, the "ground truth" equivalent would be established engineering and biocompatibility standards, and clinical outcomes data from the predicate device that inform the safety and effectiveness profile.
8. Sample Size for the Training Set
Not applicable. This is not an AI/ML algorithm requiring a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable.
§ 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.