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The Tritanium® C Anterior Cervical Cage is indicated for use in cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level or two contiguous levels from the C2 to T1 disc.

DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have six weeks of non-operative therapy.

The Tritanium® C Anterior Cervical Cage System is to be used with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, and is to be implanted via an open, anterior approach.

The Tritanium® C Anterior Cervical Cage System is intended to be used with supplemental spinal fixation systems that have been cleared for use in the cervical spine.

The Stryker Spine Tritanium® C Anterior Cervical Cage is a hollow, ring shaped titanium alloy (Ti-6Al-4V) interbody fusion cage intended for use in the cervical spine. The cage consists of an open window for bone graft containment and has serrations on the superior and inferior surfaces of the cage for fixation. The cage is offered in a variety of footprints, heights, and lordotic angles to adapt to varying patient anatomies. The Tritanium® C Anterior Cervical Cage consists of a unique configuration of both solid and porous structures that are simultaneously built using Laser Rapid Manufacturing (LRM) method applying Stryker's proprietary Tritanium® In-Growth Technology. The Tritanium® C Anterior Cervical Cage is provided sterile.

This document is a 510(k) summary for the Stryker Spine Tritanium® C Anterior Cervical Cage, an intervertebral body fusion device. It details the device's characteristics, intended use, and the non-clinical testing performed to establish substantial equivalence to predicate devices.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

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

This document describes non-clinical (bench) testing, not a clinical trial with a "test set" of patient data. Therefore, the concepts of human "sample size" and "data provenance" (country, retrospective/prospective) are not applicable in this context. The testing was performed on representative units of the medical device.

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

This is a non-clinical device safety and performance evaluation. "Ground truth" in the context of human expert consensus is not applicable. The "ground truth" for this type of evaluation is defined by adherence to established engineering standards (ASTM) and FDA guidance documents. The expertise involved would be in manufacturing, materials science, and biomechanical engineering, typically internal or external testing labs, but not clinical "experts" establishing ground truth in the sense of medical diagnosis.

4. Adjudication Method for the Test Set

As this is non-clinical bench testing, an "adjudication method" involving human readers or experts in the clinical sense is not applicable. The results are objectively measured against predefined criteria from the standards and guidance documents.

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

An MRMC study is relevant for imaging or diagnostic AI devices. This document is for an intervertebral body fusion device (an implant). Therefore, an MRMC comparative effectiveness study is not applicable. There is no AI component mentioned in the context of this device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This device does not have an "algorithm only" or "human-in-the-loop" component in the sense of a diagnostic or AI-powered device. The device itself is an implant. Standalone performance refers to the device's mechanical and material properties as tested on a bench. All the performance data described (demonstrated substantially equivalent performance) represents the standalone performance of the physical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For this non-clinical submission, the "ground truth" is based on:

• Engineering Standards: Specific ASTM standards (e.g., F2077, F2267, F1147, F1044, F1160, E8/E8M, F2129-15). These standards define test methodologies and often include performance benchmarks or criteria for material properties and mechanical performance.
• FDA Guidance Documents: Such as the "Class II Special Controls Guidance Document: Intervertebral Body Fusion Device" and guidance related to modified metallic surfaces and additive manufactured devices. These documents outline the expected performance characteristics and testing requirements for this type of device.
• Predicate Device Performance: The primary "ground truth" for substantial equivalence is the demonstrated performance of legally marketed predicate devices. The new device's performance is compared to these established benchmarks to show it is "substantially equivalent" and thus equally safe and effective.

8. The Sample Size for the Training Set

This document describes non-clinical testing for a physical implant, not an AI/machine learning device that would require a "training set." Therefore, the concept of a training set sample size is not applicable.

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

Since there is no "training set" for an AI algorithm in this context, the method for establishing its "ground truth" is not applicable.

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