(63 days)
CarboClear Cervical Plate System is intended for anterior fixation of the cervical spine.
The system is indicated for use in temporary stabilization of the anterior spine during the development of cervical spine fusion in patients with the following:
Degenerative disc disease (DDD) (as identified by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), spinal stenosis and tumors, deformity (e.g., scoliosis, kyphosis, lordosis), pseudoarthrosis, failed previous fusions.
The CarboClear Cervical Plate System comprises implants (plates and screws) in different dimensions, and instruments.
The CarboClear cervical plates are made of carbon fiber reinforced polyetheretherketone (CFR-PEEK) and may incorporate tantalum markers. The screws are made of titanium alloy.
This is a 510(k) premarket notification for a medical device, specifically the CarboClear® Cervical Plate System. These types of submissions typically focus on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving the device meets specific acceptance criteria in the way a diagnostic AI/ML device would.
Therefore, the provided document does not contain the information requested in points 1-9 regarding acceptance criteria and a study proving a device meets those criteria, particularly in the context of an AI/ML powered diagnostic or prognostic device.
The document discusses the following:
- Device Name: CarboClear® Cervical Plate System
- Intended Use: Anterior fixation of the cervical spine for temporary stabilization during fusion development in patients with various spinal conditions.
- Materials: Carbon fiber reinforced PEEK for plates, titanium alloy for screws.
- Predicate Devices: Several predicate devices are listed, including Spider® Cervical Plating System and Anterior CSLP System.
- Substantial Equivalence: The submission claims substantial equivalence based on intended use, design, materials, technological characteristics, principles of operation, and mechanical performance.
- Performance Testing: Static and dynamic compression bending, static torsion (per ASTM F1717), and static screw pushout testing were conducted, and the results were found to be comparable to predicate devices. Bacterial endotoxin evaluation was also performed.
To answer your specific questions, based only on the provided text, I must state that the requested information is not present:
- A table of acceptance criteria and the reported device performance: Not provided. The document states "Performance characteristics... are comparable to those of predicate devices," but no specific acceptance criteria or quantitative performance data are given.
- Sample size used for the test set and the data provenance: Not applicable or provided. This is physical device testing, not a data-driven AI/ML study.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable or provided. Ground truth in this context would likely refer to engineering specifications and measurements.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable or provided.
- 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 diagnostic device.
- 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.): Not directly specified in terms of "ground truth" for a diagnostic study. Mechanical performance is compared against predicate devices and ASTM standards.
- The sample size for the training set: Not applicable. This is not an AI/ML device with a training set.
- How the ground truth for the training set was established: Not applicable. This is not an AI/ML device with a training set.
§ 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.