(27 days)
The Hybrid 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 pseudoarthosis 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 Hybrid Anterior Cervical Plate System consists of an assortment of plate and screws. The Hybrid Anterior Cervical Plate System also contains Class 1 manual surgical instruments and cases that are considered exempt from premarket notification.
This is a 510(k) premarket notification for a medical device (Hybrid Anterior Cervical Plate System), not an AI/ML device. Therefore, the majority of the requested information (e.g., acceptance criteria for AI performance, sample sizes for AI training/test sets, expert adjudication, MRMC studies, standalone AI performance) is not applicable.
However, I can extract information related to the device's performance data and indications for use, which are analogous to acceptance criteria in the context of a 510(k) submission for a non-AI device.
Here's the relevant information:
1. A table of acceptance criteria and the reported device performance
For a 510(k) device like this, "acceptance criteria" are generally demonstrated through material properties, mechanical testing, and comparisons to a legally marketed predicate device to establish substantial equivalence. The document states that "Performance data were submitted to characterize the Hybrid Anterior Cervical Plate System components." This implies that the device underwent testing to ensure its mechanical integrity and functional performance.
| Acceptance Criteria (Demonstrated through comparison to predicate and mechanical testing) | Reported Device Performance |
|---|---|
| Biocompatibility | Manufactured from ASTM F-136 implant grade titanium alloy (established biocompatibility) |
| Mechanical Strength and Stability (e.g., flexion, extension, lateral bending, axial rotation, pull-out strength of screws) | Performance data were submitted to characterize the Hybrid Anterior Cervical Plate System components. This data demonstrated it is substantially equivalent to the SLIM-LOC™ Anterior Cervical Plate System (K013877). |
| Fit and Function | The system consists of an assortment of plate and screws, designed for unicortical screw fixation at the anterior face of the vertebral bodies from C2 to C7, similar to the predicate. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is typically not detailed in a 510(k) summary for mechanical devices, as the "test set" refers to mechanical test samples, not patient data. The document does not specify the number of test samples used for material or mechanical testing. Data provenance in the sense of patient data is not applicable here.
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)
This is not applicable to a 510(k) submission for a mechanical device. Ground truth, in this context, would be established through engineering specifications and objective mechanical testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable to a conventional mechanical device 510(k). Mechanical testing results are typically evaluated against pre-defined engineering standards.
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, as this is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable, as this is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For this mechanical device, the "ground truth" for performance would be established through:
- Engineering specifications and material standards: Ensuring the materials meet ASTM F-136 implant grade titanium alloy.
- Mechanical test results: Demonstrating the device's strength, stability, and integrity under simulated physiological conditions, showing substantial equivalence to the predicate device.
8. The sample size for the training set
Not applicable, as this is not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable, as this is not an AI/ML device.
§ 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.