(57 days)
The C-Tek® MaxAnTM Anterior Cervical Plate System is intended for anterior interbody fixation of the cervical spine. Indications for use include the temporary stabilization of the anterior spine during the development of cervical fusions in patients with degenerative disc disease (as defined by neck pain of discogenic origin confirmed by patient history and radiographic studies), trauma including fractures, tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudarthroses, and/or failed previous fusions. The intended levels for treatment range from C2 - T1.
The C-Tek® MaxAn™ Anterior Cervical Plate System consists of titanium alloy plates and screws. Screws are provided in both fixed and variable versions in sizes 4.0 mm and 4.5 mm with lengths from 8-26 mm. Screws will be provided in both sterile and nonsterile configurations. Cervical plates are provided in both sterile and non-sterile configurations for 1 - 6 levels and in appropriate lengths from 8-150 mm.
The provided text describes a 510(k) premarket notification for a medical device called the C-Tek® MaxAn™ Anterior Cervical Plate System. This is a spinal intervertebral body fixation orthosis.
Based on the document, this is not an AI/ML medical device. It is a traditional medical device (a physical implantable system of plates and screws). Therefore, many of the requested fields related to AI/ML device studies (such as sample size for training/test sets, expert adjudication, MRMC studies, standalone performance, etc.) are not applicable and cannot be extracted from this type of submission.
Here's a breakdown of the information that is available and a note on what is not applicable:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| The technological characteristics of the C-Tek® MaxAn™ Anterior Cervical Plate System are the same as, or similar to, the predicate devices. | Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicated that the devices are functional within the intended use. |
Study Details:
- Sample size used for the test set and the data provenance: Not applicable for this type of medical device (physical implant). The "test set" would refer to the physical prototypes tested in non-clinical lab settings. The document does not specify the number of samples or prototypes tested. Data provenance is not relevant in the context of clinical data for an AI/ML device.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth, in the context of an AI/ML device, refers to verified labels for data. For a physical medical device, "ground truth" would relate to engineering specifications and performance standards.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This refers to methods for consensus building among human experts labeling data, which is not relevant for this device.
- 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 not an AI/ML device and human readers are not involved in its "performance" in this context.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For this physical device, the "ground truth" for performance is likely based on engineering specifications, material properties (ASTM F-136 for Ti-6Al-4V), and biomechanical testing standards for spinal implants, demonstrating equivalency to predicate devices. The document explicitly states "Non-clinical laboratory testing was performed to determine substantial equivalence."
- The sample size for the training set: Not applicable. This is not an AI/ML device.
- How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.
Additional Information from the Submission:
- Device Description: The C-Tek® MaxAn™ Anterior Cervical Plate System consists of titanium alloy plates and screws. Screws are provided in both fixed and variable versions in sizes 4.0 mm and 4.5 mm with lengths from 8-26 mm, in both sterile and non-sterile configurations. Cervical plates are provided in both sterile and non-sterile configurations for 1-6 levels and in lengths from 8-150 mm.
- Materials: Titanium alloy (Ti-6Al-4V, ASTM F-136).
- Predicate Device(s):
- Performance Claim: "The technological characteristics of the C-Tek® MaxAn™ Anterior Cervical Plate System are the same as, or similar to, the predicate devices."
- Study Conclusion: "Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicated that the devices are functional within the intended use."
§ 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.