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The GEO Staple System is intended for fixation of small bone fragments, fixation of osteotomies, and joint arthrodesis.

The GEO Stable System consists of symmetric, barbed and smooth, superelastic Nitinol allov compression bone staples in varying lengths and widths. The System also includes associated instrumentation consisting of a stable inserter, drill bit and locator pins. The nitinol implant material conforms to ASTM F2063-12 Standard Specification for Wrought Nickel-Titanium Shape Memory Alloys for Medical Devices and Surgical Implants. GEO Staples are offered in widths ranging from 8mm – 25mm. To facilitate implantation, GEO Staples are provided preloaded in the Staple Inserter. All GEO Staple System components (implants and instruments) are provided sterile and for single use only.

I apologize, but the provided text from the FDA 510(k) clearance letter for the "GEO Staple System" does not contain any information about a study involving software or AI performance, acceptance criteria for such a study, or details about ground truth establishment or expert involvement.

The document is purely related to the clearance of a physical medical device (bone staples) and its equivalence to predicate devices based on material properties, mechanical testing, and biocompatibility.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them in the context of an AI/software-driven medical device. The information you are asking for (e.g., sample size for test/training sets, experts for ground truth, MRMC study, standalone performance) is not present in this document, as it pertains to the validation of a different type of medical device (AI/Software as a Medical Device).

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