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When used as a single-level partial vertebral body replacement devices are indicated for use in the cervical spine (C2-T1) of skeletally mature patial replacement (i.e., partial vertebrectomy) of a vertebral body resected or excised for the treatment of tumors, or traumaffracture, or osteomyelitis, or to achieve decompression of the spinal cord and neural tissues in cervical degenerative disorders. The device is intended for use with autograft or allogenic bone graft comprising cancellous and/or corticocancellous bone graft. When the Galileo™ device is used as a single-level, partial vertebral body replacement device, supplemental fixation may be used.

The Galileo Vertebral Body Replacement device is a surgical grade titanium (Ti-6A1-4V) device and is available in various widths and heights. It has openings of various sizes to allow for the placement of bone graft and for the free flow of cells between the bone graft and the bone of the patient. It is intended for partial vertebral body replacement in a single vertebra and to hold bone graft material.

The provided document does not describe the acceptance criteria and study that proves a device (Galileo Vertebral Body Replacement Device) meets the acceptance criteria in the context of an AI/ML medical device.

The document is a 510(k) summary for a physical medical device: a vertebral body replacement. The studies described are non-clinical mechanical performance tests (ASTM F2077 and ASTM F2267) to demonstrate the device's structural integrity and resistance to subsidence and expulsion. These are standard engineering tests for implantable devices, not AI/ML performance evaluation studies.

Therefore, I cannot provide the requested information regarding AI/ML device acceptance criteria, performance, sample sizes, expert ground truth adjudication, MRMC studies, or training set details, as this information is not present in the provided text.

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