(104 days)
The VERTEBRON SCP™ Cervical Plate System is intended for anterior interbody fixation of the cervical spine. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudoarthriosis, and/or failed previous fusions. The SCP™ Cervical Plate System can be implanted in the sub-axial cervical spine from C3 through C7 levels.
The Reduced Stature VERTEBRON SCP™ Cervical Plate System is comprised of non-sterile, single-use, titanium alloy components. The VERTEBRON SCP™ Cervical Plate System attaches to the vertebral body by means of self tapping and self drilling cervical screws. This system's design is intended to stabilize the spinal operative site during the fusion process of a bone graft in the disc space. This submission adds a reduced stature cervical plate.
The provided text describes a medical device, the VERTEBRON SCP™ Cervical Plate System, and its clearance process with the FDA. However, it does not contain any information about acceptance criteria or a study proving the device meets those criteria in the context of device performance metrics typically associated with AI/ML algorithms (e.g., sensitivity, specificity, accuracy).
The document is a 510(k) premarket notification summary, which focuses on demonstrating substantial equivalence to predicate devices rather than proving specific performance against quantitative acceptance criteria through a clinical study. The "study" mentioned refers to mechanical testing for equivalence, not a clinical performance study with human subjects, ground truth, or expert readers.
Therefore, most of the requested information cannot be extracted from this document, and the following answers reflect that absence.
Acceptance Criteria and Device Performance Study Information
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Not applicable | Not applicable |
| (The document does not specify quantitative acceptance criteria for clinical or diagnostic performance, nor does it report such performance metrics.) | (The document discusses mechanical testing to demonstrate substantial equivalence to predicate devices, but this is not reported in terms of clinical performance metrics like sensitivity, specificity, or accuracy.) |
2. Sample size used for the test set and the data provenance
- Sample Size: Not applicable (No test set for clinical performance is described).
- Data Provenance: Not applicable (No clinical data provenance is described). The study mentioned is mechanical testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable (No experts for establishing ground truth are mentioned as this is not a study assessing diagnostic or clinical performance against ground truth).
4. Adjudication method for the test set
- Not applicable (No adjudication method is mentioned).
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
- No, an MRMC comparative effectiveness study was not done. The device is a cervical plate system, not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. The device is a physical implant, not an algorithm.
7. The type of ground truth used
- Not applicable. The document describes mechanical testing for substantial equivalence, not a study requiring clinical or diagnostic ground truth. The "ground truth" for the mechanical testing would be the physical properties and performance of the device under specific loads, as compared to established standards (ASTM F1717) and predicate devices.
8. The sample size for the training set
- Not applicable (No training set is mentioned as this device is not an AI/ML product).
9. How the ground truth for the training set was established
- Not applicable (No training set or associated ground truth establishment is mentioned).
§ 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.