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The CarboClear Vertebral Body Replacement (VBR) System is intended for use during open surgical procedures in the thoracolumbar spine (T1-L5) to replace a collapsed, or unstable vertebral body due to tumor or trauma (e.g., fracture).

The CarboClear Vertebral Body Replacement device is intended to be used with supplemental internal spinal fixation systems that have been labeled for use in the thoracic and lumbar spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems).

The use of allograft or autograft with the CarboClear Vertebral Body Replacement device is optional.

The CarboClear VBR System comprises implants (spacers) in different dimensions, and instruments. The CarboClear VBR spacers are made of carbon fiber reinforced polyetheretherketone (CFR-PEEK), with titanium alloy endplates.

The provided document is a 510(k) summary for the CarboClear® VBR System, a medical device for spinal intervertebral body fixation. It does not describe an AI/ML powered device, nor does it detail a study proving device performance against acceptance criteria in the manner requested (e.g., with specific metrics like sensitivity, specificity, or human reader improvement with AI assistance).

The document focuses on demonstrating substantial equivalence of the CarboClear® VBR System to predicate devices through an assessment of its intended use, design, materials, technological characteristics, principles of operation, and mechanical performance characteristics.

Therefore, I cannot extract the information required for an AI/ML powered device study from this document. The sections you requested (acceptance criteria table, sample size, expert ground truth, MRMC study, standalone performance, etc.) are deeply specific to the evaluation of AI/ML models, not for a physical implant device like the CarboClear® VBR System.

The closest relevant information concerning "performance" in this document refers to mechanical testing standards for an implant:

• Performance characteristics included static and dynamic axial compression and torsion testing per ASTM F 2077, expulsion testing, and endplate shear strength testing.
• Performance characteristics are comparable to those of predicate devices (as applicable), thus demonstrating that the device is substantially equivalent to the predicates.

This indicates that the "acceptance criteria" were likely defined by meeting or exceeding the mechanical performance standards established in ASTM F 2077 and demonstrating comparability to predicate devices for these physical attributes. However, specific numerical acceptance criteria (e.g., a minimum axial compression strength) and reported performance values are not provided in this summary for confidentiality reasons, as this is a 510(k) summary, not the full submission. Similarly, the "study" proving this performance would be the mechanical testing described, not a clinical study involving human outcomes or an AI algorithm's performance.

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