(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.
Warning: This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.
The EBI SpineLink™ System is a cervical spinal fixation device that uses interconnecting links. This submission is for design modifications to the previously cleared 4.5mm, 5.5mm, 6.5mm bone anchor screws, the cervical lock nut, and the associated instrumentation.
The provided document, K993822, is a 510(k) summary for a medical device (EBI SpineLink™ Anterior Cervical Spinal System). It is a regulatory submission for pre-market notification of a medical device, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a detailed clinical study demonstrating device performance against specific acceptance criteria. This type of submission does not typically include the detailed information requested in your prompt regarding acceptance criteria, study design, ground truth establishment, or sample sizes related to performance evaluation in the way you might expect for an AI/CADe device.
Therefore, many of your requested points cannot be extracted from this document, as they are not relevant to a 510(k) for a spinal fixation system that relies on substantial equivalence.
Here's an analysis based on the information available in the document:
1. A table of acceptance criteria and the reported device performance
This document does not specify quantitative "acceptance criteria" or report "device performance" in terms of clinical outcomes or diagnostic metrics. Instead, it demonstrates substantial equivalence to predicate devices. The "performance" aspect is addressed by an "Engineering Analysis comparing the modifications to the previous system," which "demonstrated that the device complies with applicable standards and meets all of its functional requirements." However, the specific standards, functional requirements, and the results of this analysis are not detailed in this summary.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This is a spinal fixation system, not a diagnostic device evaluated with test sets of data. The submission relies on engineering analysis and comparison to predicate devices, not clinical data sets in the context you describe.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. Ground truth, in the context of diagnostic or AI studies, is not established for this type of device submission.
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
Not applicable. This is a spinal fixation system, not an AI or diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable.
8. The sample size for the training set
Not applicable. This document is not about an AI/ML algorithm requiring a training set.
9. How the ground truth for the training set was established
Not applicable.
Summary of what is provided in the document related to "acceptance criteria" and "study":
The document states that an Engineering Analysis was performed to compare the modified device components (4.5mm, 5.5mm, 6.5mm bone anchor screws, the cervical lock nut, and associated instrumentation) to the previous cleared system.
- Acceptance Criteria (Implied): The device complies with "applicable standards" and "meets all of its functional requirements." The specific standards and functional requirements are not detailed but would be related to mechanical strength, biocompatibility (materials: Ti-6A1-4V ELI per ASTM F136), and design integrity for a spinal implant.
- Study: The "Engineering Analysis" serves as the "study." This would involve mechanical testing, material characterization, and design review to ensure the modifications do not adversely affect safety or effectiveness compared to the predicate. The document states: "An Engineering Analysis comparing the modifications to the previous system demonstrated that the device complies with applicable standards and meets all of its functional requirements."
In conclusion, this 510(k) summary for a spinal fixation device focuses on substantial equivalence based on engineering analysis and material comparisons, not detailed clinical trial data or performance against diagnostic acceptance criteria as is common for AI/CADe devices.
§ 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.