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The Stansion Matrix™ ("Stansion Matrix") is indicated for use in the thoracolumbar spine (i.e., T1 to L5) to replace a portion of a diseased vertebral body that is resected or excised for the treatment of tumors, where the defect is contained within a single vertebral body, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The device is also indicated for treating fractures of the thoracic and lumbar spine. The Stansion Matrix is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period of time. The device is intended for use with supplemental rigid posterior pedicle screw fixation.

The device is a single piece titanium VBR that is open on all sides to maximize bone ingrowth. It is available in three sizes. The device is implanted via the posterior approach, according to similar methods as the predicates. An insertion tool is provided with the device to facilitate its implantation.

The provided text is a 510(k) summary for the Stansion Matrix™ Vertebral Body Replacement device. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, this document does not contain any information about acceptance criteria, device performance from studies, or details about the rigorous testing methodologies often associated with AI/software devices.

The Stansion Matrix is a physical medical device (vertebral body replacement), not an AI or software device. Therefore, the questions related to AI/software performance metrics (like acceptance criteria for algorithms, sample sizes for test sets, expert adjudication, MRMC studies, standalone performance, training sets, etc.) are not applicable to the content provided.

The document discusses the physical characteristics of the device and its similarity to predicate devices, focusing on materials, shape, and method of use to establish substantial equivalence. Performance testing is only mentioned generally: "Any minor differences in technological features do not raise new issues of safety or effectiveness, as confirmed by performance testing." It does not provide details of such tests.

Therefore, I cannot fulfill the request as the input document does not contain the necessary information about acceptance criteria or studies proving device performance from the perspective of an AI/software device.

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