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CAVUX™ Cervical Cage is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C3-C7) with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received at least six weeks of non-operative treatment prior to treatment with the device. Devices are intended to be used with autogenous bone graft and supplemental fixation, such as an anterior plating system.

The CAVUX™ Cervical Cage is a cervical intervertebral body fusion device. The system is comprised of a variety of implant sizes to accommodate various patient anatomies and pathology. All implantable components are manufactured from medical grade titanium alloy (6AI4V —ELI Ti). The center of the implant is hollow and is to be filled with autogenous bone material. The design incorporates "windows" through the implant to permit visualization of the graft material and, over time, formation of new bone.

This document pertains to the 510(k) premarket notification for the CAVUX™ Cervical Cage, an intervertebral body fusion device. The acceptance criteria and the study proving the device meets them are outlined in the "Performance Testing" section and the subsequent "Conclusions".

1. Table of Acceptance Criteria and Reported Device Performance

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

The document describes performance testing using the subject device (CAVUX™ Cervical Cage) and comparing its results to those of a predicate device (PMT Cervical Cage). However, it does not specify the exact sample sizes (number of devices tested) for each of the mechanical or pyrogenicity tests.

The data provenance is from bench testing, meaning it's laboratory-generated data rather than clinical data from human subjects. The country of origin of this testing is not explicitly stated, but the company is based in California, USA. The testing is prospective in the sense that the tests were conducted specifically to evaluate the device prior to its submission for market clearance.

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

This type of testing (mechanical and pyrogenicity) does not involve human experts establishing ground truth in the way clinical studies do. The "ground truth" is defined by the technical specifications of the ASTM standards and FDA guidance documents. Therefore, this question is not applicable in the context of this device's performance testing.

4. Adjudication Method for the Test Set

As the performance testing is based on objective, quantifiable measurements against established engineering and biological standards, there is no need for an adjudication method by human experts. The results are directly compared to the numerical limits and requirements set by the standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

No MRMC comparative effectiveness study was done. This device is a physical intervertebral fusion cage, not an AI-powered diagnostic or assistive tool. Therefore, this question is not applicable.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

No standalone performance evaluation was done. This question is not applicable as the device is not an algorithm or AI system.

7. The Type of Ground Truth Used

The ground truth for the performance testing is based on:

• Engineering standards: ASTM F2077-14 (Static and Dynamic Axial Compression, Static and Dynamic Torsion), ASTM F2267-04 (Subsidence Testing), and ASTM Draft Standard F-04.25.02.02 (Expulsion Testing). These standards define the methodology and acceptance limits for mechanical performance.
• Regulatory guidance: FDA Guidance Documents for Pyrogenicity Testing ("Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile: Guidance for Industry and Food and Drug Administration Staff" and "Pyrogen and Endotoxins Testing: Questions and Answers"). These define the acceptable levels of pyrogenic substances.

8. The Sample Size for the Training Set

There is no training set in the context of this device's performance testing. Training sets are relevant for machine learning algorithms, which are not involved here.

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

This question is not applicable as there is no training set for this type of device.

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