(24 days)
When intended to promote fusion of the occipitocervical spine, cervical spine, and the thoracic spine, (Occiput-T3), the VERTEX® Reconstruction System is indicated for the following: DDD (neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, spinal stenosis, fracture, dislocation, failed previous fusion and/or tumors.
Occipitocervical Plate/Rod/Occipital Screws/Hooks: The occipitocervical plate/rods, occipital screws (3.5mm, 4.0mm and 4.5mm cancellous), and hooks are intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the occipitocervical junction and the cervical spinc. When used to treat these occipitocervical and cervical conditions, these screws are limited to occipital fixation only. The screws are not intended to be placed in the cervical spine. The use of the occipitocervical plate/rod requires bilateral fixation to C2 and below. Note: segmental fixation is recommended for these constructs.
Hooks and Rods: The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.
Multi-axial Screws/Connectors: The use of multi-axial screws (3.5mm and 4.0mm cancellous, and 4.0mm cortical) are limited to placement in T1-T3. The screws are not intended to be placed in the cervical spine.
Titanium ATLAS® Cable System used with the VERTEX® Reconstruction System allows for cable attachment to the posterior cervical or thoracic spine.
The VERTEX® Reconstruction System is a posterior system, which consists of a variety of shapes and sizes of rods, hooks, screws, multi-axial screws, and connecting components, which can be rigidly locked to the rod in a variety of configurations, with each construct being tailormade for the individual case. Titanium ATLAS® cable may be used with this system at the surgeon's discretion. The VERTEX® Reconstruction System is fabricated from medical grade titanium or titanium alloy. The VERTEX® Reconstruction System also includes a retaining ring for the multi-axial screw made of Shape Memory Alloy (Nitinol – NiTi). Shape Memory Alloy is compatible with medical grade titanium or titanium alloy implants only. Do not use with stainless steel. The purpose of this submission was to add modified lateral connectors to the VERTEX® Reconstruction System.
This is a 510(k) premarket notification for a medical device (VERTEX® Reconstruction System), which focuses on demonstrating substantial equivalence to previously cleared devices rather than establishing novel safety and effectiveness through a traditional clinical study with acceptance criteria and measured device performance.
Therefore, the provided document does not contain the information requested regarding acceptance criteria or a study proving the device meets them in the way a clinical trial or performance study would for a new device.
Here's why and what information is available:
- Type of Submission: This is a 510(k) submission. For 510(k)s, the primary goal is to show the new device is "substantially equivalent" to a legally marketed predicate device, meaning it has the same intended use and the same technological characteristics, or if there are different technological characteristics, they do not raise different questions of safety and effectiveness.
- Missing Information: The document does not describe:
- Specific acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) for device performance.
- A study designed to measure the device's performance against such criteria.
- Sample sizes, data provenance, expert ground truth establishment, adjudication methods for a test set, MRMC studies, or standalone algorithm performance.
- Training set details for an algorithm, as this device is a mechanical implant, not an AI/software device.
- What is Present: The document states that "Documentation has been provided which demonstrates that the VERTEX® Reconstruction System is substantially equivalent to VERTEX® Reconstruction System that was previously cleared in K042524 and K003780." This is the "study" and "proof" in the context of a 510(k) – it's a comparison to predicates, not a performance evaluation against a set of criteria.
In summary, as this is a 510(k) for a mechanical spinal implant system, the requested information pertaining to acceptance criteria and a study demonstrating performance in the context of AI/software algorithm evaluation (like sensitivity, specificity, expert ground truth, sample sizes, etc.) is not applicable and is not present in the provided text. The "study" here is a substantial equivalence comparison to predicate devices, which is a regulatory pathway, not a performance measurement study in the typical sense.
§ 888.3050 Spinal interlaminal fixation orthosis.
(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.