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The Fuji Cervical Plate System is intended for anterior interbody fixation of the cervical spine. The system is indicated for use in temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies); trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudosarthrosis and/or failed previous fusions. The Fuji Cervical Plate System can be implanted in the sub-axial cervical spine from the C3 through C7 levels.

The purpose of this submission is to add the addition of a 4.5mm screw offering for the current FDA cleared Fuji Cervical plate System. It is intended for anterior fixation of the cervical spine. The fixation construct consists of a cervical plate that is attached to the vertebral body of the cervical spine with both self-tapping and self-drilling bone screws. The plates are available in a variety of lengths addressing multiple levels of fixation (one to four). The Fuji Cervical Plate System includes graft windows on the longitudinal center line for intraoperative visualization and for screw fixation of bone graft. Fixed or variable bone screws are available in two diameters and a variety of lengths, with the options of either self-tapping or self-drilling threads.

This document describes a 510(k) premarket notification for a medical device called the "Fuji Cervical Plate System." This is a spinal implant used for spinal fusion, not an AI/Software as a Medical Device (SaMD). Therefore, the information typically contained in an acceptance criteria and study section for SaMD products (such as a table of performance metrics like sensitivity/specificity, sample sizes for test/training sets, expert adjudication methods, MRMC studies, or standalone algorithm performance) is not applicable to this submission.

Instead, the submission focuses on demonstrating substantial equivalence to a legally marketed predicate device (Altus Spine Cervical Plate System K163061), primarily through non-clinical bench testing and engineering analysis, rather than clinical performance (e.g., diagnostic accuracy or treatment efficacy measured in human subjects).

Here's a breakdown of the relevant information provided in the document:

Device: Fuji Cervical Plate System
Type of Device: Spinal Intervertebral Body Fixation Orthosis (Implantable Hardware)
Regulatory Pathway: 510(k) Premarket Notification (demonstrates substantial equivalence to a predicate device)

Given that this is a hardware device for spinal fixation, not an image analysis or diagnostic AI, the requested information on acceptance criteria and study proving performance in the context of AI/SaMD is not present and not relevant to this specific FDA clearance.

The document implicitly states that the acceptance criteria for this type of device are typically related to:

• Mechanical performance: Ensuring the device can withstand the forces it will experience in the human body (e.g., fatigue, static strength). This is assessed through non-clinical bench testing.
• Biocompatibility: Ensuring the materials are safe for implantation. (Stated as Titanium Alloy that conforms to ASTM F136).
• Design equivalence: Demonstrating that the new features (e.g., 4.5mm screw offering) do not introduce new safety or effectiveness concerns compared to the predicate device.

What is described in the document as evidence:

• Summary of Non-Clinical Tests Submitted: "Engineering analysis was presented to demonstrate that the Fuji Cervical Plate System line extension does not present a new worst case in performance and is substantially equivalent to the predicates."
  • This implies that tests such as static compression, pull-out strength, fatigue testing, or other biomechanical assessments were performed, and their results met pre-defined engineering and mechanical standards. However, the specific acceptance values or detailed results are not provided in this summary document.
• Substantial Equivalence Conclusion: "The Fuji Cervical Plate System is substantially equivalent to the predicate devices in terms of intended use, material used, and performance. The device has a similar design, dimensions and instrumentation to the predicate devices."

To reiterate, the questions about AI/SaMD performance metrics and study design (e.g., MRMC, expert ground truth, training/test sets) are not applicable to the Fuji Cervical Plate System as presented in this FDA 510(k) summary.

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