(159 days)
The Cyclone™ Anterior Cervical Plate System is intended to provide stabilization during the process of cervical spinal fusion (C2-C7) 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), pseudoarthrosis, and/or failed previous fusions.
The Cyclone™ Anterior Cervical Plate System is a fixation device consisting of cervical plates (locking mechanism is pre-assembled to plates) and unicortical screws made from titanium alloy in conformance with ASTM F136. The plates are offered in one-level, two-level, and three-level fusion configurations (14mm-69mm). There are four different lengths of the standard 4mm diameter screw (12, 14, 16, and 18mm). The rescue screw has a diameter of 4.4mm and lengths are 12, 14 and 16mm.
This 510(k) summary does not contain information about acceptance criteria or specific study data to prove the device meets those criteria, as it is a premarket notification for a medical device (Cyclone™ Anterior Cervical Plate System) seeking substantial equivalence to existing devices.
Medical devices cleared through the 510(k) process typically demonstrate substantial equivalence to a predicate device, rather than performing clinical studies with specific acceptance criteria in the way a new drug or novel high-risk device might. The focus is on demonstrating that the new device is as safe and effective as a legally marketed device.
Therefore, many of the requested categories (like sample size, ground truth, expert qualifications, MRMC studies, standalone performance, and training set details) are not applicable or not mentioned in this type of submission for this device.
Here's a breakdown based on the provided text, indicating what information is available and what is not:
1. A table of acceptance criteria and the reported device performance
- Not applicable / Not present. This 510(k) submission doesn't define specific "acceptance criteria" and "reported device performance" in the context of a clinical study with outcome metrics. Instead, it asserts substantial equivalence based on similarity in design, indications, and materials to predicate devices.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable / Not present. No test set or associated sample size is mentioned, as this is not a clinical study report for an AI/algorithm-based device.
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 / Not present. No ground truth establishment by experts is described, as this is not an AI/algorithm validation study.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Not present. No test set or adjudication method is mentioned.
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 / Not present. This is not an AI-assisted diagnostic or imaging device, so an MRMC study is irrelevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable / Not present. This is a physical implantable medical device, not an algorithm, so standalone performance in that context is not relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable / Not present. No ground truth is described.
8. The sample size for the training set
- Not applicable / Not present. This is a physical device, not a machine learning model, so there is no "training set."
9. How the ground truth for the training set was established
- Not applicable / Not present. No training set or ground truth for it is relevant to this device.
What is present in the document related to "proving" the device (in the context of a 510(k) submission):
The "proof" in this context is the Basis for Substantial Equivalence (Section 6), which states:
- "The Cyclone™ Anterior Cervical Plate System is similar in design, indications and materials to Centerpulse Spine-Tech's Trinica Select Anterior Cervical Plate (K022344) and Medtronic Sofamor Danek's Zephir Anterior Cervical Plate (K994239)."
This statement serves as the core "proof." The FDA reviewed the submission and agreed with this assertion, as indicated by the clearance letter (K031214). The detailed evidence for this similarity (e.g., mechanical testing data, material composition comparison, design specifications) would be contained within the full 510(k) submission, but is not detailed in this summary.
In summary, the provided document is a 510(k) summary for a physical medical device. It does not contain the specific types of performance data or study details typically associated with AI/algorithm-based devices as per your template.
§ 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.