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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 fraumatic 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 disease of 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 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 alloy, and cobalt chromium. 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.

The provided text is a 510(k) premarket notification for the Medtronic VERTEX™ Reconstruction System. This document outlines the regulatory review process and the basis for the FDA's determination of substantial equivalence to predicate devices. It does not present acceptance criteria or detailed study results for device performance in the way a clinical trial or performance study report would for an AI/ML medical device.

The VERTEX™ Reconstruction System is an orthopedic spinal fixation system, not a software or AI-driven diagnostic device. Therefore, the information typically found in an acceptance criteria table for an AI/ML device (e.g., sensitivity, specificity, AUC) and a detailed description of clinical performance studies (MRMC, standalone, ground truth establishment) is not present in this type of FDA submission.

Instead, the submission focuses on:

• Substantial Equivalence: Demonstrating that the device is as safe and effective as legally marketed predicate devices.
• Technological Characteristics: Highlighting similarities and differences from predicates (in this case, primarily the sterile presentation of the subject rods versus non-sterile for predicates).
• Performance Data (Non-Clinical): Covering biocompatibility (by material equivalence to predicates) and mechanical testing (by relying on predicate device testing as the subject device does not introduce a new worst-case). Endotoxin testing is also mentioned for the sterile product.

Therefore, I cannot fulfill the request to describe acceptance criteria and the study that proves the device meets the acceptance criteria, as this information (as it pertains to clinical performance metrics for an AI/ML device) is not contained within the provided document.

The document states:

• VIII. Conclusions: "Based on the sterilization assessment, packaging assessment, and additional supporting documentation provided in this pre-market notification, the subject VERTEX™ Reconstruction System implants demonstrate substantial equivalence to the previously listed predicate devices."

This indicates that the "acceptance criteria" for this device's approval are related to demonstrating mechanical, material, and labeling equivalence, and the "study" is the collection of engineering assessments and comparisons to predicate devices, rather than a clinical performance study with human subjects or a test set of data.

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