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4CIS® Marlin PEEK ACIF Cage is indicated for use in cervical intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at the levels from the C2-C3 disc to the C7-T1 disc. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should have six weeks of non-operative therapy in advance. The 4CIS® Marlin PEEK ACIF Cage 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. It is intended to be used with supplemental spinal fixation systems that have been cleared for use in the cervical spine, such as Anterior Cervical Plate system.

4CIS® Marlin PEEK ACIF Cage is single component devices used to restore height of disc space by anterior approach and to facilitate cervical interbody fusion with maintaining physiological lordotic angulation of cervical spine. To allow maximum preservation and ensure ample contact surfaces with bony endplate, a variety of shapes and sizes are available and each device has three tantalum markers for ease of visualization on radiographs. The vertical square teeth on the top and the bottom surface prevent subsidence of the cage into the vertebral body while they increase the anchoring and prevent slipping or expulsion. To make solid fusion of intervertebral body, hollow space in the implant allows bone graft material to be filled. The implant has safety proven structure and material (Poly-ether-ether-ketone, ASTM F2026) to promote biological synostosis and assures mechanical safety against load.

This FDA 510(k) summary describes a medical device, the 4CIS® Marlin PEEK ACIF Cage, which is an intervertebral body fusion device. The provided text is a regulatory filing for this device and does not contain information about software or AI performance metrics. Therefore, it is not possible to answer your questions regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance, as these pertain to the evaluation of AI/software device performance, which is not discussed in this document.

The document focuses on demonstrating substantial equivalence of the physical implant device to predicate devices through mechanical testing and comparison of characteristics.

Here's a breakdown of the information that is present and why your specific questions about AI/software performance cannot be answered from this text:

Information Present in the Document:

• Device Name: 4CIS® Marlin PEEK ACIF Cage
• Intended Use: Cervical intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at specific cervical levels (C2-C3 disc to C7-T1 disc). It is to be used with bone graft and supplemental spinal fixation systems.
• Material: Poly-ether-ether-ketone (PEEK), conforming to ASTM F2026.
• Design Features: Single component, designed to restore disc height, facilitate fusion, maintain lordotic angulation, various shapes/sizes, three tantalum markers for visualization, vertical square teeth to prevent subsidence and aid anchoring, hollow space for bone graft.
• Predicate Devices: 4CIS® Marlin ACIF Cage System (K162402) as primary; PATRIOT SPACERS: COLONIAL ACDF (K072991), TRYPTIK Ca (K091873), MATISSE Anterior Cervical Interbody Fusion Cage System (K162682) as additional.
• Performance Data (Non-Clinical): Mechanical testing was conducted in accordance with ASTM F2077-17 and F2267-04. This included static axial compression, static compression-shear, static torsion, dynamic axial compression, dynamic compression-shear, dynamic torsion, and static subsidence.
• Conclusion: The device is substantially equivalent to legally marketed predicate devices based on overall technology characteristics and mechanical performance data.

Why Your Questions Cannot Be Answered from This Document:

Your questions pertain to the evaluation of AI or software-based medical devices. The 4CIS® Marlin PEEK ACIF Cage is a physical medical implant, not a software or AI device. Therefore, the concept of "acceptance criteria" in the context of AI performance, "test set," "training set," "ground truth," "experts for ground truth," "adjudication," or "MRMC studies" as they relate to AI algorithms simply do not apply to this regulatory filing. The "performance data" mentioned refers solely to the biomechanical properties of the physical implant.

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