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The 3d Cage is an intervertebral body fusion device indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-L5. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six months of nonoperative therapy. The device is indicated to be used with a supplemental fixation system and autograft bone.

3d Cage™ is an intervertebral body fusion cage intended for use in (Posterior/Transforaminal) lumbar spinal fixation procedures. It is an open architecture truss designed to provide effective structural support with open space throughout the implant for bone growth and fusion. The cage is provided sterile and constructed from titanium alloy (Ti-6Al-4V, ASTM F3001) using Selective Laser Melting (SLM) method.

This document, a 510(k) Summary for the FIMS 3d Cage™, describes a medical device, specifically an intervertebral body fusion device, and seeks to establish its substantial equivalence to previously cleared predicate devices.

However, the provided text does not contain the information requested in the prompt regarding acceptance criteria and a study proving the device meets those criteria for an AI/ML-based medical device.

The document primarily focuses on:

• Device Description: The 3d Cage™ is an intervertebral body fusion cage made of titanium alloy, constructed using Selective Laser Melting (SLM).
• Intended Use: For skeletally mature patients with Degenerative Disc Disease (DDD) at L2-L5, with up to Grade I spondylolisthesis, who have undergone six months of non-operative therapy. It's used with a supplemental fixation system and autograft bone.
• Technological Characteristics: Made of Ti-6Al-4V alloy, similar to predicate devices.
• Performance Data: Refers to non-clinical testing (static and dynamic compression, shear, and subsidence) adhering to ASTM standards (F2077-18, 14, F2267-04). This is mechanical testing for a physical implant, not performance data for an AI/ML diagnostic or assistive device.
• Conclusion: The device is substantially equivalent to predicate devices based on material, indication for use, and design.

Therefore, I cannot extract the information required to answer your specific questions related to AI/ML device performance, acceptance criteria, and clinical study details (like sample sizes, expert involvement, ground truth, or MRMC studies) because this document describes a physical implant, not an AI/ML-based medical device.

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