(28 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 allov, 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, 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.
The provided text is a 510(k) summary for the VERTEX® Reconstruction System, which is a spinal interlaminal fixation orthosis. It primarily discusses the device's description, indications for use, and a statement of substantial equivalence to predicate devices. It does NOT contain information about specific acceptance criteria or a study proving the device meets those criteria in the context of device performance metrics commonly used for AI/software devices (e.g., sensitivity, specificity, AUC).
Instead, the "study" mentioned refers to mechanical testing performed to demonstrate substantial equivalence to previously marketed devices.
Therefore, I cannot provide the requested information in the format of acceptance criteria and device performance as this document does not contain that type of data.
However, I can extract the relevant information from the document to address the components of your request as best as possible given the available text:
Summary of Information from the Provided Document:
This 510(k) summary is for a medical device (spinal implant system), not an AI/software device. The concept of "acceptance criteria" and "device performance" in the context of AI models (like sensitivity, specificity, AUC, sample size of test/training sets, ground truth establishment, expert adjudication, MRMC studies) are not applicable or detailed in this type of regulatory submission for a physical implant.
The "study" referenced in the document is mechanical testing to demonstrate substantial equivalence.
Here's a breakdown based on the provided text, addressing your points where possible, and noting where information is not present:
1. Table of Acceptance Criteria and Reported Device Performance
- Acceptance Criteria (Implicit): The primary acceptance criterion for this 510(k) submission is "Substantial Equivalence" to legally marketed predicate devices. This is demonstrated by showing that the new device has the same intended use, similar technological characteristics, and that any differences do not raise new questions of safety or effectiveness.
- Reported Device Performance: 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."
- Specific performance metrics (e.g., strength, durability, fatigue resistance) are not enumerated in this summary document, nor are numerical acceptance thresholds. The summary only provides the conclusion of the mechanical testing.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Mechanical properties equivalent to or better than predicate devices to ensure safety and effectiveness for spinal fixation. | "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 Data Provenance
- Not applicable in the context of AI/software test sets. The "test set" here would refer to the samples used in mechanical testing.
- Sample Size: Not specified in the document.
- Data Provenance: Not specified in the document (country of origin, retrospective/prospective). This would apply to the origin of the mechanical test samples themselves or the testing methodology.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable in the context of AI/software ground truth. The "ground truth" for a physical implant's mechanical testing comes from engineering standards and physical measurements.
- Number of Experts & Qualifications: Not specified, as it's not relevant to mechanical testing for substantial equivalence in this context.
4. Adjudication Method for the Test Set
- Not applicable in the context of AI/software adjudication. Mechanical testing results are typically objectively measured and compared to predefined engineering specifications or predicate device performance, not adjudicated by human experts in the way AI model outputs are.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No, an MRMC study was not done. This type of study is specifically designed for evaluating the impact of AI on human reader performance, which is not relevant for the regulatory approval of a physical spinal implant system.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical spinal implant system, not an algorithm.
7. The Type of Ground Truth Used
- Engineering/Mechanical Standards and Predicate Device Performance: The "ground truth" for the mechanical testing would be established by industry standards for spinal implants and/or the measured performance of predicate devices against which the new system is being compared for substantial equivalence.
8. The Sample Size for the Training Set
- Not applicable. This device is a physical spinal implant system, not an AI model requiring a training set.
9. How the Ground Truth for the Training Set was Established
- Not applicable. There is no "training set" for this type of device.
In conclusion: The provided document is a 510(k) summary for a physical medical device (spinal implant). It is focused on demonstrating "substantial equivalence" through mechanical testing, not on the performance metrics or study designs typically associated with AI or software devices as implied by your detailed questions.
§ 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.