(28 days)
The EBI VueLock™ Anterior Cervical Plate System is intended for anterior interbody screw fixation of the cervical spine. The System is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with degenerative disc disease (as defined by neck pain of discogenic origin of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudarthrosis, and/or failed previous fusions.
The EBI VueLock™ Anterior Cervical Plate System is a cervical spinal fixation device of plates and screws. The plates contain a locking ring mechanism, which locks the screws into place. The plates are designed to span between one and four levels, and are manufactured from titanium. This submission is for the addition of Self Drilling Screws to the System.
The provided text describes a 510(k) summary for the EBI VueLock™ Anterior Cervical Plate System. This is a medical device for spinal fixation, and the document focuses on regulatory approval rather than a clinical study evaluating AI performance. Therefore, most of the requested information about acceptance criteria, study sizes, expert involvement, and AI-specific metrics is not present in the provided text.
However, based on the information available, here's what can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Functional Requirements | "The mechanical testing demonstrated that the device complies with applicable standards and meets all of its functional requirements." |
| Compliance with Applicable Standards | "The mechanical testing demonstrated that the device complies with applicable standards..." |
| Substantial Equivalence to Predicate Devices (Intended Use, Materials, Function) | "It is substantially equivalent to the predicate devices in regards to intended use, materials and function." |
2. Sample size used for the test set and the data provenance:
- Not Applicable. The submission primarily discusses mechanical testing and a comparison to predicate devices, not testing on human subjects for AI performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This information is for AI performance evaluations, which are not detailed here.
4. Adjudication method for the test set:
- Not Applicable. This information is for AI performance evaluations, which are not detailed here.
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. The document does not mention any MRMC study or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. The document does not describe any standalone algorithm performance.
7. The type of ground truth used:
- Mechanical Testing Results and Predicate Device Characteristics: The "ground truth" for this submission appears to be the standards for mechanical performance and the characteristics of previously approved (predicate) spinal fixation devices.
8. The sample size for the training set:
- Not Applicable. This document describes a medical device, not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established:
- Not Applicable. See point 8.
§ 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.