(90 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 fogense in the temporary stabilization of the anterior spine during the development of cervical spinal fusions 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, or scoliosis), pseudarthrosis, and/or failed previous fusions. WARNING: This device is not approved for screw attachments of the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.
The EBI SpineLink™ Anterior Cervical Spinal System is an anterior cervical spinal fixation system.
The provided 510(k) summary (K973923) for the EBI SpineLink™ Anterior Cervical Spinal System focuses on demonstrating substantial equivalence to predicate devices through a comparison of technological characteristics, intended use, and materials. It explicitly states that "Bench testing comparing the system to a predicate system demonstrated that the device complies with applicable standards and meets all of its functional requirements."
However, this document does not contain specific acceptance criteria, reported device performance metrics (e.g., in a table), sample sizes for test or training sets, details on ground truth establishment, expert qualifications, adjudication methods, or results of MRMC studies common for AI/diagnostic devices.
This type of submission predates the common requirements for AI-based diagnostic devices or those involving clinical studies with detailed performance metrics. The focus is on mechanical and material equivalence.
Therefore, many of the requested fields cannot be filled from the provided text.
Here's a breakdown of what can be extracted and what cannot:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Applicability to standards and functional requirements compared to predicate device | "complies with applicable standards and meets all of its functional requirements" (demonstrated through bench testing) |
| Intended Use Equivalence | Substantially equivalent for anterior interbody screw fixation of the cervical spine at levels C3-C7 for specified indications. |
| Material Equivalence | Manufactured from Ti-6AI-4V ELI per ASTM F136, substantially equivalent to predicate devices. |
| Function Equivalence | Uses links instead of plates for the "same intended use in a similar construct," substantially equivalent to predicate devices. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified in the document. The study involved "bench testing."
- Data Provenance: Not applicable in the context of bench testing for a mechanical device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This was bench testing of a mechanical device, not a diagnostic or AI device requiring expert-established ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable.
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. This is a spinal fixation system, not an AI or diagnostic device that would typically involve MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This refers to a mechanical device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not applicable. The "ground truth" for bench testing would be engineering specifications, material properties, and mechanical load limits, not clinical "ground truth."
8. The sample size for the training set
- Not applicable. There is no training set for a mechanical device undergoing bench testing.
9. How the ground truth for the training set was established
- Not applicable.
Summary based on the provided document:
The EBI SpineLink™ Anterior Cervical Spinal System's acceptance criteria were primarily based on demonstrating substantial equivalence to existing legally marketed predicate devices. This was achieved through:
- Comparison of intended use, materials, and functional characteristics.
- Bench testing to show compliance with applicable standards and functional requirements when compared to a predicate system.
The document K973923 is a 510(k) summary from 1997 for a medical device (a spinal fixation system), not a diagnostic algorithm or AI product. Therefore, the detailed information typically requested for AI/diagnostic studies (like expert consensus, sample sizes for training/test sets, MRMC studies) is not present in this type of submission. The "study" mentioned is "bench testing" which demonstrated mechanical and material performance consistent with predicate devices and established standards.
§ 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.