(35 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 Components: Plate Rod/Plates/Rods/Occipital Screws/Hooks
The occipitocervical plate rods, plates, rods, occipital screws, 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.
Occipitocervical constructs require 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 is limited to placement in T1-T3. The screws are not intended to be placed in the cervical spine.
Titanium ATLAS® Cable System to be used with the VERTEX® Reconstruction System allows for cable attachment to the posterior cervical or thoracic spine.
In order to achieve additional levels of fixation, the VERTEX® Reconstruction System may be connected to the CD HORIZON® Spinal System rods with the VERTEX® rod connectors. Refer to the CD HORIZON® Spinal System package insert for a list of the CD HORIZON® Spinal System indications of use.
The VERTEX® Reconstruction System is a posterior system, which consists of a variety of shapes and sizes of plates, 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 tailor-made for the individual case. Titanium ATLAS® cable may be used with this system at the surgeon's discretion. See the package inserts of both of those systems for labeling limitations.
The VERTEX® Reconstruction System is fabricated from medical grade titanium, medical grade titanium alloy, and medical grade cobalt chromium. Medical grade titanium, medical grade titanium alloy, and/or medical grade cobalt chromium may be used together. Never use titanium alloy, and or/cobalt chromium with stainless steel in the same construct. The VERTEX® Reconstruction System includes a retaining ring for the multi-axial screw made of Shape Memory Alloy (Nitinol -- NiTi). Shape Memory Alloy is compatible with titanium, titanium alloy, and cobalt chromium implants only. Some multi-axial screws contain elastomeric stakes made of silicone adhesive commonly used in implantable medical devices. Do not use with stainless steel. No warranties, express or implied, are made. Implied warranties of merchantability and fitness for a particular purpose or use are specifically excluded. See the MDT Catalog or price list for further information about warranties and limitations of liability.
To achieve best results, do not use any of the VERTEX® Reconstruction System implant components with components from any other system or manufacturer unless specifically labeled to do so in this or another MEDTRONIC document. As with all orthopedic and neurosurgical implants, none of the VERTEX® Reconstruction System components should ever be reused under any circumstances.
This 510(k) summary describes a medical device, the VERTEX® Reconstruction System, and its substantial equivalence to previously marketed devices. It does not contain information about acceptance criteria or a study demonstrating the device meets such criteria in terms of performance metrics like sensitivity, specificity, or accuracy.
Instead, the document focuses on:
- Substantial Equivalence: The primary "acceptance criteria" discussed here is the demonstration that the VERTEX® Reconstruction System is substantially equivalent to legally marketed predicate devices. This is a regulatory pathway for medical devices in the United States, indicating that the new device is as safe and effective as a similar device already on the market.
- Mechanical Testing: The document states, "The results of mechanical testing performed for the subject VERTEX® Reconstruction System components were equivalent to or better than the testing performed for the predicate VERTEX® Reconstruction System components." This implies that the device underwent physical performance tests (e.g., strength, durability, fatigue) and met or exceeded the performance of the predicate device. However, specific acceptance criteria for these tests (e.g., "must withstand X force for Y cycles") and the detailed results are not provided in this summary.
Therefore, I cannot populate the table or answer the specific questions about device performance metrics, sample sizes for test/training sets, ground truth establishment, or clinical study methodologies (like MRMC studies) because this information is not present in the provided text. This type of detail is typically found in the full submission to the FDA, not necessarily in the public 510(k) summary.
Based on the provided text, here is what can be inferred/extracted regarding the "acceptance criteria" and "study":
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial Equivalence to predicate devices | "Documentation was provided demonstrating that the VERTEX® Reconstruction System is substantially equivalent to other commercially available posterior fixation systems and other pre-enactment devices including the VERTEX® Reconstruction System." |
| Mechanical performance equivalent to or better than predicate devices | "The results of mechanical testing performed for the subject VERTEX® Reconstruction System components were equivalent to or better than the testing performed for the predicate VERTEX® Reconstruction System components." |
2. Sample size used for the test set and the data provenance:
- Not provided. The summary mentions "mechanical testing" but does not specify the sample size of components tested or the provenance of any data used beyond the general statement of comparison to predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable / Not provided. The summary focuses on mechanical and regulatory equivalence, not on clinical performance assessed by experts in a diagnostic or therapeutic context. No "ground truth" concerning patient outcomes or expert diagnoses is mentioned for this type of device (spinal implant).
4. Adjudication method for the test set:
- Not applicable / Not provided. Since no expert review or "ground truth" establishment by multiple individuals is described, an adjudication method is not mentioned.
5. 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, not performed/applicable. This device is a spinal implant, not an AI-powered diagnostic or assistive tool. MRMC studies are not relevant to its regulatory pathway as described here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No, not performed/applicable. This is a physical medical device (implant), not an algorithm.
7. The type of ground truth used:
- Mechanical Performance Data / Regulatory Equivalence. For this device, the "ground truth" for its "performance" in the context of this 510(k) is the established mechanical performance of predicate devices and the regulatory standard of substantial equivalence.
8. The sample size for the training set:
- Not applicable / Not provided. There is no "training set" in the AI/machine learning sense for this device.
9. How the ground truth for the training set was established:
- Not applicable / Not provided.
§ 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.