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The VERTEX® Reconstruction System is intended to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7) and the thoracic spine from T1-T3: traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudarthrosis); tumors involving the cervical spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative diseaseof the facets with instability. The VERTEX® Reconstruction System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

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. Transition rods with differing diameters may also be used to connect the VERTEX® Reconstruction System to the CD HORIZON® Spinal System. 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. Conditions of the cervical spine, such as degenerative disc disease, tumor, or trauma, can lead to instability and pain for patients. In order to treat the instability, surgeons may need to use implants to reconstruct the spine. The VERTEX® Reconstruction System is a comprehensive set of options that provides adjustability, flexibility, and adaptability to meet the anatomical challenges of the occipitocervical and upper thoracic spine. The VERTEX® Reconstruction System is intended to be implanted by an orthopedic surgeon as described in the Surgical Technique. Each construct is specifically designed for each individual case. The components of the VERTEX® Reconstruction System are fabricated from medical grades of commercially pure titanium (ASTM F67-13), titanium alloy (ASTM F136-13), and cobalt chromium (ASTM F1537-11). The VERTEX® Reconstruction System also includes a retaining ring for the use with the multi-axial screw which is fabricated from Shape Memory Alloy, Nitinol-NiTi (ASTM F2063-12).

The sole purpose for this submission is to update the labeling for the VERTEX® Reconstruction System to include MRI safety information while also providing MRI technologists with a method of concluding whether an MRI scan can be performed and specific instructions on how to perform the scan.

This document describes the MRI safety evaluation of the VERTEX® Reconstruction System. It does not describe an AI medical device. Therefore, it's not possible to provide acceptance criteria and study details as they would apply to an AI device.

However, I can extract the information related to the MRI safety evaluation which is the focus of this submission. This is not an AI device, so many of the requested fields (like number of experts, adjudication methods, multi-reader studies, training sets) are not applicable.

Here's a summary of the MRI safety evaluation details:

Overall Purpose of Submission: To update the labeling for the VERTEX® Reconstruction System to include MRI safety information and instructions on how to perform an MRI scan with the device.

1. Table of Acceptance Criteria and Reported Device Performance (for MRI Safety)

Conclusion from all evaluations: The VERTEX® Reconstruction System was determined to be MR-conditional.

2. Sample Size Used for the Test Set and Data Provenance:

• A comprehensive computer simulation study was used to identify worst-case configurations for RF-induced heating. The document doesn't specify a "sample size" in terms of number of different construct models but states it involved "evaluating simple models (rods, screws, hooks) and adding additional components to create a more complex model."
• "Worst-case configurations" identified from simulations were physically tested in real MR scanners (both 1.5 T and 3 T). The specific number of constructs or tests conducted is not explicitly stated as a "sample size" but implies sufficient testing to cover critical configurations.
• The provenance is from Medtronic Sofamor Danek USA, Inc.'s internal testing and simulation studies, as described in their 510(k) submission. This is a prospective evaluation for the purpose of regulatory clearance.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

• This is not applicable as the study involves engineering and physics testing against established ASTM standards for MRI safety, not interpretation of medical images or clinical outcomes by experts.

4. Adjudication Method for the Test Set:

• Not applicable for this type of engineering and physics testing. Compliance is determined by meeting the specified limits and methodologies of the ASTM standards.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No, this is not an AI device or a diagnostic imaging aid. Therefore, no MRMC study was conducted.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

• Not applicable, as this is a medical implant and its MRI safety evaluation, not a standalone algorithm. The "computer simulation study" aspect is a part of the engineering design and testing, not an AI algorithm.

7. The Type of Ground Truth Used:

• The "ground truth" here is the established physical principles and safety limits defined by international ASTM standards regarding MRI compatibility (e.g., maximum temperature rise, acceptable displacement force, torque, and artifact levels). The physical testing confirms adherence to these standards.

8. The Sample Size for the Training Set:

• Not applicable. There is no "training set" as this is not a machine learning or AI algorithm. The computer simulations are for identifying test configurations, not for training a model.

9. How the Ground Truth for the Training Set Was Established:

• Not applicable as there is no training set for an AI model.

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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 construct 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, titanium alloy, and or/cobalt chromium with ataless 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) - Thane Memory Alloy is compatible with titanium, titanium alloy, and cobalt chrom. Shippe only. Some multi-axial screws contain elastomeric stakes made of silicore 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 orthopedia 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. It describes the device, its indications for use, and its substantial equivalence to other legally marketed devices.

However, the document does not contain any information regarding acceptance criteria, device performance, sample sizes for test or training sets, data provenance, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.

The "V. Substantial Equivalence" section mentions: "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 indicates that some form of testing was done to demonstrate equivalence, likely mechanical strength or fatigue testing, but the specific acceptance criteria and detailed results are not provided in this summary.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance or the other detailed information about a study based on the provided text. The document is a regulatory summary, not a detailed study report.

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