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The Nexus Anterior Cervical Plate System is intended for anterior fixation to the cervical spine. The specific clinical indications include:

degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.

The Nexus Anterior Cervical Plate System consists of a variety of shapes and sizes of main plates, screws, sub-plates, rivets and associated instruments. The sub-plate is pre-assembled to the main plate and designed to prevent screws from backing out using the elastic behavior during the screw insertion.

The rivets are pre-assembled to the main plate, which firmly attach the sub-plate component to the main plate. Each component is color anodized to differentiate the screw type and diameter and to facilitate the surgical process.

The plates range in length to accommodate one, two, three, and four level procedures. Main plates are available from 20mm to 110mm. Screws are available in lengths from 10mm to 20mm in 2mm increments. The screws have either a 3.5mm or 4.0mm diameter. They are provided in fixed self-tapping, variable self-tapping, fixed self-drilling and variable self-drilling configurations.

This document describes a 510(k) submission for the Nexus Anterior Cervical Plate System. This is a medical device for spinal fixation, not an AI/ML device, and therefore the requested information regarding acceptance criteria and studies (like sample size, ground truth, expert opinions, MRMC studies, standalone performance, training set) is not applicable in the context of this submission.

The core of this submission is a demonstration of substantial equivalence to a previously cleared predicate device (Dio Medical Rex Anterior Cervical Plate System, K121862). This means the device is being cleared because it is deemed to be as safe and effective as a device already on the market, not through a process involving performance metrics against acceptance criteria tested in a clinical or AI performance study.

Here's why the AI/ML specific questions are not applicable:

• No AI/ML Component: The Nexus Anterior Cervical Plate System is hardware (plates, screws, sub-plates, rivets) used for physical fixation in cervical spine surgery. It is a traditional medical device, not a software algorithm, diagnostic tool, or any other device that would typically involve AI/ML.
• Substantial Equivalence (Predicate Device): The submission explicitly states: "The subject device is identical to the previously cleared Rex System in terms of indications for use, device dimensions instrumentation, manufacturing process, cleaning/sterilization process and labeling." And "Non-clinical testing was not performed as part of this submission." This indicates that the approval relies on the fact that the new device is essentially the same as one already approved, and therefore, extensive new testing (especially AI/ML performance testing) is not required.

Therefore, I cannot provide a table of acceptance criteria and reported device performance or answer questions 2-9 from your prompt because they relate to the evaluation of AI/ML models or clinical studies that were not performed or required for this type of 510(k) submission.

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