(80 days)
The SKYLINE® Anterior Cervical Plate System is indicated for stabilization of the cervical spine from C2 to C7 employing unicortical screw fixation at the anterior face of the vertebral bodies. Specific clinical indications for anterior plating include: Instability caused by trauma; instability associated with correction of cervical lordosis and kyphosis deformity; instability associated with pseudoarthorosis as a result of previously failed cervical spine surgery; instability associated with major reconstructive surgery for primary tumors or metastatic malignant tumors of the cervical spine; instability associated with single or multiple level corpectomy in advanced degenerative disc disease, spinal canal stenosis and cervical myleopathy.
The SKYLINE® System consists of cervical plates and screws which are terminally sterilized via gamma radiation. Previously, these devices were commercialized as clean, but non-sterile, and the end-user would need to sterilize the units prior to use via steam sterilization. Certain screws will be packaged in sterile multi-packs for customer convenience.
This document pertains to a 510(k) premarket notification for the SKYLINE® Anterior Cervical Plate System. The core of this submission is about a change in the sterilization method (from non-sterile to terminally sterilized via gamma radiation) for an already cleared device. Therefore, the information provided focuses on the substantial equivalence to the predicate device based on this change, rather than a clinical study evaluating the device's clinical performance against specific acceptance criteria in the conventional sense of a diagnostic or AI-powered device.
As a result, many of the typical acceptance criteria and study details requested for an AI/diagnostic device (e.g., sample sizes, expert ground truth, MRMC studies, standalone performance) are not applicable to this type of submission. This 510(k) is primarily concerned with verifying that the change in sterilization does not alter the fundamental safety, efficacy, or performance characteristics of the device, which is demonstrated through a comparison to a predicate device and assessment of manufacturing processes and materials.
Here's a breakdown based on the provided document, addressing the requested points where applicable and explaining why others are not relevant:
1. A table of acceptance criteria and the reported device performance
For this specific 510(k), acceptance criteria are not in the form of diagnostic performance metrics (e.g., sensitivity, specificity). Instead, the "acceptance criteria" are demonstrating substantial equivalence to the predicate device, particularly regarding the change in sterilization. The key "performance" reported is that the device remains functionally identical.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety & Efficacy with New Sterilization Method | Substantially equivalent to predicate device (K052552) |
| - Biocompatibility (Impact of Gamma Radiation on Materials) | Not required to be re-tested; the sterile devices do not require biocompatibility testing. The design, materials, and technology remain identical. |
| - Mechanical/Structural Integrity (Impact of Gamma Radiation) | Design, materials, and technology remain identical to the predicate systems. Implies no change in mechanical performance. |
| - Intended Use | Identical intended use as the predicate device (stabilization of cervical spine C2-C7). |
| - Materials | Manufactured from ASTM F-136 implant grade titanium alloy (identical to predicate). |
| Predicate Device Performance as Reference | The predicate device (K052552) was previously cleared and deemed safe and effective. |
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 not a study assessing diagnostic performance or clinical outcomes in humans that would require a test set of patient data. The "test" here involves demonstrating that the sterilized product is equivalent to the unsterilized predicate.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. There is no "ground truth" establishment in the context of clinical data for this type of submission. The evaluation is based on engineering, materials science, and regulatory compliance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. See point 3.
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 device is a surgical implant, not an AI or diagnostic imaging device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This device is a surgical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not Applicable. The "ground truth" for this submission revolves around established engineering standards, material specifications (ASTM F-136), and regulatory requirements for medical devices and sterilization methods, rather than clinical patient data. The primary "ground truth" is that the predicate device itself was previously cleared as safe and effective.
8. The sample size for the training set
- Not Applicable. There is no training set as this is not an AI/ML device.
9. How the ground truth for the training set was established
- Not Applicable. There is no training set.
Summary of the Study (as described in K103491):
The "study" or justification demonstrating the device meets the (implied) acceptance criteria is a substantial equivalence comparison to a previously cleared predicate device (SKYLINE® Anterior Cervical Plate System, cleared as the Hybrid Anterior Cervical Plate System, K052552).
- Nature of the Study: This is a regulatory submission demonstrating that a modification (change to terminal gamma sterilization) to an existing device (SKYLINE® Anterior Cervical Plate System) does not alter its fundamental safety, efficacy, or performance compared to its predicate.
- Key Argument: The design, materials (ASTM F-136 implant grade titanium alloy), and technology of the plates and screws remain identical to the predicate systems. The intended use also remains unchanged.
- Biocompatibility: The submission states that the sterile devices do not require biocompatibility testing, implying that either the gamma sterilization is a well-understood process for these materials that does not negatively impact biocompatibility or that prior testing for the predicate already covered relevant considerations.
- Conclusion: The submission concludes that the sterile SKYLINE® devices are as safe, as effective, and perform as well as the predicate device, thus establishing substantial equivalence.
In essence, the "study" is a technical and regulatory argument, based on established knowledge of materials and sterilization, rather than a clinical trial with human subjects and diagnostic performance metrics.
§ 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.