(48 days)
The NexGen Anterior Cervical Plate System is indicated for use in temporary stabilization of the anterior spine from C2 to T1 during the development of cervical spinal fusions in patients with: degenerative disc disease (DDD) (as defined by neck pain of discogenic origin with degeneration of disc confirmed by patient history and radiographic studies); spondylolisthesis; trauma (including fractures or dislocations); spinal tumors; deformity (defined as kyphosis, lordosis, or scoliosis); spinal stenosis; pseudoarthrosis; and failed previous fusions.
The NexGen Anterior Cervical Plate System components are temporary implants that are intended for anterior interbody screw fixation of the cervical spine during the development of a cervical spinal fusion. The NexGen Anterior Cervical Plate System consists of a variety of shapes and sizes of bone plates, screws (available in self-drilling or self-tapping configurations), and associated instruments. Fixation is provided by bone screws inserted into the vertebral body of the cervical spine using an anterior approach.
The provided document is a 510(k) summary for the NexGen Anterior Cervical Plate System. It describes the device and its equivalence to predicate devices, but it does not contain information about acceptance criteria for a device performance study or the results of such a study in terms of metrics like sensitivity, specificity, or AUC.
Instead, the document details a non-clinical test summary focused on mechanical properties to demonstrate substantial equivalence to predicate devices. It explicitly states: "No clinical studies were performed."
Therefore, I cannot provide the requested information regarding acceptance criteria, reported device performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, or the type of ground truth used for performance evaluation, as this information is not present in the provided text.
The closest relevant information is the Non-clinical Test Summary, which describes the testing performed for the device's mechanical integrity.
Here's what can be extracted from the document regarding the non-clinical testing:
Device Meeting Acceptance Criteria (Non-Clinical Mechanical Testing):
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mechanical strength and durability to be "as strong or stronger than the predicate devices" in static and dynamic conditions. | The results of evaluations for • Static and dynamic compression and torsion per ASTM F1717 showed that the NexGen Anterior Cervical Plate System is as strong or stronger than the predicate devices. |
Missing Information (Not provided in the document):
- Sample size used for the test set and the data provenance: Not applicable as no clinical study or test set for performance was conducted.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
Summary of what the document does provide:
- Non-clinical Test Summary: Static and dynamic compression and torsion testing per ASTM F1717.
- Conclusion: The device is "as strong or stronger than the predicate devices."
- Clinical Test Summary: "No clinical studies were performed."
This device's clearance is based on substantial equivalence to predicate devices primarily through mechanical performance testing and similarity in design, materials, and intended use, rather than a clinical performance study with human subjects or AI algorithm evaluations.
§ 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.