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The STGC is indicated for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged or unstable vertebral body due to tumor or trauma (i.e. fracture). The STGC is intended to be used with autograft or allograft in combination with supplemental fixation indicated for use in the thoracolumbar spine.

The STGC is a vertebral body replacement device manufactured from titanium alloy (Ti-6Al-4V), and is available in a variety of sizes to suit the individual anatomic and clinical circumstances of each patient. The STGC is a single-piece device manufactured using electrical discharge machining, having a trapezoidal cross section with a hollow interior to accommodate the placement of autograft or allografi bone. Intended for placement via an anterior approach, the STGC is to be used in combination with supplemental fixation indicated for use in the thoracolumbar spine.

The provided text describes the 510(k) summary for the STGC vertebral body replacement device, which focuses on demonstrating substantial equivalence to predicate devices based on design and performance testing. It does not describe a study involving algorithms, human readers, or AI. Therefore, I cannot generate the requested information regarding acceptance criteria and a study that proves a device meets those criteria in the context of AI or algorithm performance.

The document is a submission for a medical device (a spinal implant), not an AI or diagnostic device that would typically have the kind of performance metrics requested (e.g., sensitivity, specificity, F1-score, or an MRMC study).

The "Performance testing" mentioned refers to mechanical tests conducted to demonstrate the structural integrity and equivalence of the STGC device to existing predicate devices, using ASTM standards. This is a very different type of "performance" than what is typically assessed for an AI or diagnostic device.

Therefore, most of the specific points you asked for, such as sample size for the test set, data provenance, number of experts, adjudication methods, MRMC studies, standalone algorithm performance, and training set details, are not applicable or present in this document.

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