(69 days)
The NuVasive HELIX Mini Anterior Cervical Plating System is intended for anterior screw fixation of the cervical spine. These implants have been designed to provide stabilization as an adjunct to cervical fusion. Indications for the use of this implant system include degenerative disc disease defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma, spinal stenosis, deformity, tumor, pseudarthrosis or failed previous fusion.
WARNING: The NuVasive HELIX Mini Anterior Cervical Plating System is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.
The NuVasive HELIX Mini ACP System consists of a variety of plates and screws designed to provide stabilization as an adjunct to cervical fusion.
The provided text describes the NuVasive HELIX Mini ACP System, a cervical plate and screw system. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than detailing extensive clinical studies with specific acceptance criteria and performance metrics.
Based on the provided text, a comprehensive table of acceptance criteria and reported device performance, as well as several other requested details, cannot be fully populated. The document explicitly states:
- H. Summary of Clinical Tests (Not Applicable).
- G. Summary of Non-Clinical Tests: Mechanical testing was presented. (However, no specific details about the mechanical testing, acceptance criteria, or quantitative results are provided in this summary.)
This means that a detailed study proving the device meets specific acceptance criteria, as typically seen in clinical trials with human subjects or in-depth performance evaluations, is not present in this document. The FDA's substantial equivalence determination for this device was based on comparison to a predicate device and non-clinical (mechanical) testing, not on clinical effectiveness studies that would generate the kind of data requested.
Therefore, the following information is limited or unascertainable from the given text:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (If applicable) | Reported Device Performance (If applicable) |
|---|---|
| Not specified in this document. | Not specified in this document. |
Study Details
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not applicable. The document states "Summary of Clinical Tests (Not Applicable)". Mechanical testing was mentioned, but no sample size or details of the test set are provided.
- 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. No clinical test set requiring expert ground truth is described.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No clinical test set requiring adjudication is described.
- 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:
- No. This device is a physical spinal implant system, not an AI or imaging diagnostic tool. Therefore, an MRMC study is not relevant.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This device is a physical spinal implant system, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable. No clinical test set requiring ground truth is described. For the mechanical testing mentioned, the "ground truth" would likely be based on engineering specifications and physical measurements, but these details are not provided.
- The sample size for the training set:
- Not applicable. No training set for an algorithm is relevant for this device.
- How the ground truth for the training set was established:
- Not applicable. No training set for an algorithm is relevant for this device.
Additional Information from the Document:
- Device Description: The NuVasive HELIX Mini ACP System consists of a variety of plates and screws designed to provide stabilization as an adjunct to cervical fusion.
- Intended Use: Anterior screw fixation of the cervical spine, providing stabilization as an adjunct to cervical fusion for conditions like degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, deformity, tumor, pseudarthrosis, or failed previous fusion.
- Predicate Device: The NuVasive HELIX Mini ACP System is substantially equivalent to the HELIX ACT System.
- Comparison to Predicate: The subject device has identical indications for use and employs the same principles of operation as its predicate.
- Non-Clinical Tests: Mechanical testing was presented, but no specific results or acceptance criteria are detailed in this summary.
- Clinical Tests: "Not Applicable" for this 510(k) submission.
§ 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.