(90 days)
When intended as an adjunct to fusion of the occipitocervical spine, cervical spine, and the thoracic spine, (Occiput-T3), the VERTEX® Reconstruction System is indicated for skeletally mature patients using allograft and/or autograft 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 purpose of this submission is to add an adjustable Occipitocervical plate to the system. 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 components contain elastomeric stakes made of silicone adhesive commonly used in implantable medical devices. Do not use with stainless steel. 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.
The provided text is a 510(k) summary for the VERTEX® Reconstruction System, a medical device. This type of document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device.
Crucially, a 510(k) summary for a spinal fixation orthosis like the VERTEX® Reconstruction System does not typically include clinical study data with acceptance criteria for device performance based on human reader studies, ground truth establishment, or multi-reader multi-case (MRMC) comparative effectiveness studies in the way one might expect for a diagnostic AI device.
Instead, for devices like these, "acceptance criteria" and "device performance" are primarily demonstrated through mechanical testing to prove that the new device component (the adjustable Occipitocervical plate) is mechanically equivalent to the predicate device and meets established safety standards for implantable medical devices.
Therefore, many of the requested categories for AI/diagnostic studies are not applicable to this document. I will fill in the relevant information as much as possible based on the provided text.
Acceptance Criteria and Device Performance Study for VERTEX® Reconstruction System (K091365)
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria (Not explicitly stated as numeric targets in text, but implied by "equivalent") | Reported Device Performance (from K091365) |
|---|---|---|
| Mechanical Equivalence to Predicate Device | New components (adjustable Occipitocervical plate) must demonstrate equivalent mechanical properties (e.g., strength, fatigue life, stiffness) to predicate VERTEX® Reconstruction System components. | "The results of mechanical testing performed for the subject VERTEX® Reconstruction System components were equivalent to the testing performed for the predicate VERTEX® Reconstruction System components." |
| Biocompatibility | Materials must be medical grade and compatible with the human body for implantable use. (Implicit in device description) | Fabricated from medical grade titanium, medical grade titanium alloy, medical grade cobalt chromium, Shape Memory Alloy (Nitinol - NiTi), and silicone adhesive. Explicitly notes compatibility rules (e.g., "Never use titanium alloy, and or/cobalt chromium with stainless steel in the same construct"). |
| Sterility | Device must be sterile for implantation. (Implicit for all implantable devices) | Not explicitly detailed in this summary, but a standard requirement for such devices. |
| Material Properties | Materials used must meet specified standards for medical grade materials. | Uses "medical grade titanium, medical grade titanium alloy, and medical grade cobalt chromium." |
| Design Intent | The device should function as intended for stabilization and fusion in the occipitocervical, cervical, and thoracic spine. | The system "is intended to provide stabilization to promote fusion" for various spinal conditions. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not applicable in the context of clinical data for AI/diagnostic performance. For mechanical testing, specific sample sizes (number of constructs or components tested) would have been used, but these exact numbers are not detailed in the 510(k) summary. These would be found in the full 510(k) submission, not the summary.
- Data Provenance: Not applicable for clinical study data. Mechanical testing data would be generated internally by the manufacturer.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. This is a medical device, not a diagnostic AI system requiring expert consensus on image interpretation or disease diagnosis for a test set. Ground truth for mechanical testing is based on engineering standards and measurements.
4. Adjudication method for the test set
- Not Applicable. See point 3.
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
- Not Applicable. This is a spinal implant system, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used
- For mechanical testing: The ground truth is based on established engineering standards, biomechanical principles, and predicate device performance data. The performance of the new component is compared against these benchmarks and the predicate device to demonstrate equivalence. This would include measurements of parameters like yield strength, ultimate tensile strength, fatigue strength, and stiffness.
8. The sample size for the training set
- Not Applicable. This device is not an AI model that requires a training set of data.
9. How the ground truth for the training set was established
- Not Applicable. See point 8.
Summary of Relevant Information from the K091365 Document:
The K091365 document is a 510(k) summary for a Class II spinal implant. The primary method for demonstrating "acceptance criteria" and "device performance" relies on proving substantial equivalence to existing predicate devices.
The key statement regarding performance is:
"The results of mechanical testing performed for the subject VERTEX® Reconstruction System components were equivalent to the testing performed for the predicate VERTEX® Reconstruction System components."
This indicates that the "study" demonstrating performance was mechanical testing of the device components (specifically, the added adjustable Occipitocervical plate). The "acceptance criterion" was that these mechanical test results had to be equivalent to those of previously cleared predicate devices or established standards for such implants. The document does not provide details on the specific test parameters, sample sizes, or numerical results of these mechanical tests within this summary, as is typical for 510(k) summaries. These details would be part of the full 510(k) submission to the FDA.
§ 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.