(22 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 spine. 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.
The titanium ATLAS® Cable System to be 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 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 titanium or titanium alloy implants only. Do not use with stainless steel. Never use stainless steel and titanium implant components in the same construct.
The VERTEX® Reconstruction System is a medical device and its "performance" is based on mechanical testing demonstrating substantial equivalence to predicate devices, rather than clinical performance metrics typically associated with AI/software devices. Therefore, many of the requested categories are not applicable.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
This device is not a software or AI-driven system; its "performance" is demonstrated through mechanical testing to show substantial equivalence to already marketed devices. There are no specific acceptance criteria percentages (e.g., sensitivity, specificity) for device performance in this 510(k) summary, as it's a hardware device.
| Acceptance Criteria (General) | Reported Device Performance |
|---|---|
| Mechanical Equivalence to Predicate Devices | Demonstrated mechanical equivalence to five legally marketed occipito-cervico-thoracic fixation devices. |
| Material Compatibility | Fabricated from medical grade titanium alloy; retaining ring from Shape Memory Alloy (Nitinol - NiTi) compatible with titanium/titanium alloy. No use with stainless steel. |
| Intended Use | Expanded to include occiput and additional components. |
| Indications for Use (Specific) | Spinal fusion for occipitocervical, cervical, and thoracic spine (Occiput-T3) for conditions like DDD, spondylolisthesis, spinal stenosis, fracture, dislocation, failed fusion, and tumors. |
| Constraint on Screw Placement | Occipital screws limited to occipital fixation only (not cervical spine). Multi-axial screws limited to T1-T3 (not cervical spine). |
2. Sample Size for Test Set and Data Provenance
Not applicable. This device's clearance is based on mechanical testing (benchtop) rather than a clinical "test set" of patient data. Therefore, there's no data provenance in terms of country of origin or retrospective/prospective nature.
3. Number of Experts for Ground Truth and Qualifications
Not applicable. Ground truth for a hardware device in mechanical testing is typically defined by engineering specifications and objective measurements, not expert consensus.
4. Adjudication Method
Not applicable. There's no adjudication method mentioned as it's not a clinical study involving human assessment of device outcomes or image interpretation.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This is a hardware device submission, not an AI/software device that would involve human readers. Therefore, no MRMC study was performed, and there is no effect size of human readers improving with AI assistance.
6. Standalone Performance Study
In a sense, the mechanical testing is a "standalone" performance evaluation of the device components themselves, independent of human interaction in a diagnostic or interpretive capacity. However, it's not "standalone (i.e. algorithm only without human-in-the loop performance)" as understood in AI contexts. The testing determines if the components meet strength, fatigue, and other biomechanical criteria comparable to predicate devices.
7. Type of Ground Truth Used
For the mechanical testing, the "ground truth" would be engineering specifications, biomechanical standards, and comparative data from predicate devices. This involves objective measurements of strength, durability, and other physical properties.
8. Sample Size for Training Set
Not applicable. This is not a machine learning or AI device that requires a training set of data.
9. How Ground Truth for Training Set was Established
Not applicable. No training set was used.
§ 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.