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The NuVasive CoRoent ExtenSure System is a partial vertebral body replacement device indicated for use in the thoracolumbar spine (T1 to L5) to replace a diseased vertebral body resected or excised for the treatment of a collapsed, damaged, or unstable vertebral body(s) due to tumor or trauma and to achieve decompression of the spinal cord and neural tissues. The System is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the thoracic and lumbar spine. Allograft or autograft material may be used at the surgeon's discretion.

The NuVasive CoRoent ExtenSure System is an implantable PEEK vertebral body replacement device indicated for use in the thoracic and lumbar spine (i.e., T1 to L5) to replace a diseased vertebral body resected or excised for the treatment of a collapsed, replace a diseased vertebral body(s) due to tumor or trauma and to achieve decompression of the spinal cord and neural tissues. The device is available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient.

The provided text is a 510(k) summary for the NuVasive CoRoent ExtenSure System. It describes a medical device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain any information about acceptance criteria, device performance metrics, sample sizes for test or training sets, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.

The document explicitly states under "Summary of Clinical Tests H.": "(Not Applicable)". This indicates that no clinical studies were performed or required for this 510(k clearance. The clearance was based on demonstrating substantial equivalence to a legally marketed predicate device (CoRoent System - K043205) and non-clinical mechanical testing.

Therefore, I cannot provide the requested information from the given text.

The information you asked for (acceptance criteria table, sample sizes, expert details, adjudication, MRMC, standalone performance, ground truth types and establishment) are typically found in clinical study reports or comprehensive performance evaluations, which are not part of this 510(k) summary.

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