(28 days)
The EBI SpineLink™ Anterior Cervical Spinal System is intended for anterior interbody screw fixation of the cervical spine at levels C3-C7. 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 SpineLink™ System is a cervical spinal fixation device that uses interconnecting links. This submission is for the addition of a 4.5mm diameter bone anchor screw.
The provided text describes a 510(k) summary for the EBI SpineLink™ Anterior Cervical Spinal System, which is a medical device for spinal fixation. This type of submission focuses on demonstrating substantial equivalence to a predicate device already on the market rather than providing detailed clinical study data with specific acceptance criteria and performance metrics.
Therefore, many of the requested details about acceptance criteria, study design, sample sizes, ground truth establishment, expert involvement, and MRMC studies are not available in the provided text. The text primarily addresses regulatory compliance and safety/effectiveness through comparison to predicate devices, rather than a de novo clinical trial demonstrating performance against quantitative acceptance criteria.
However, I can extract the information that is present:
1. Table of acceptance criteria and the reported device performance
The document does not provide a table of explicit acceptance criteria or quantitative performance metrics typically seen in a clinical study report. Instead, the "acceptance criteria" can be inferred as demonstrating "substantial equivalence" to predicate devices and complying with applicable standards.
| Acceptance Criterion (Inferred) | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Devices | The EBI SpineLink™ Anterior Cervical Spinal System is substantially equivalent to the predicate devices (EBI SpineLink™ Anterior Cervical Spinal System and Synthes® Cervical Spine Locking Plate) in regards to intended use, materials, and function. |
| Compliance with Applicable Standards and Functional Requirements | "Testing comparing the modifications to the previous system demonstrated that the device complies with applicable standards and meets all of its functional requirements." |
2. Sample size used for the test set and the data provenance
- Sample size for test set: Not applicable/Not provided. The submission relies on comparative testing to demonstrate equivalence rather than a clinical trial with a "test set" of patients. The "testing comparing the modifications" likely refers to bench testing rather than human subject data.
- Data provenance: Not applicable/Not provided in terms of human subjects. The testing described would primarily involve mechanical or material testing of the device itself.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable/Not provided. Ground truth, typically established by experts in clinical studies, is not mentioned as this relates to a comparative device submission based on product characteristics and previous approvals.
4. Adjudication method for the test set
Not applicable/Not provided. Adjudication methods are relevant for clinical trials or studies involving expert review of outcomes, 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
Not applicable. This is a medical device for spinal fixation, not an AI-powered diagnostic tool. Therefore, an MRMC study and AI enhancement are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical spinal fixation device, not an algorithm or software.
7. The type of ground truth used
Not applicable/Not provided. The concept of "ground truth" as used in diagnostic or AI studies (e.g., pathology, outcomes data) does not apply to this device submission, which focuses on mechanical equivalence and safety.
8. The sample size for the training set
Not applicable/Not provided. Training sets are relevant for machine learning models, which this device is not.
9. How the ground truth for the training set was established
Not applicable/Not provided. 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.