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The OIC Intramedullary Screw System is indicated for the fixation of intra-articular fractures, malunions, non-unions or osteotomies of small bone fragments, as well as arthrodesis of small joints. The device is intended for use in adults.

The OIC Intramedullary Screw System consists of stainless steel screws and instruments to facilitate implantation. The screws come in two diameters, 3.6mm and 4.5mm, and range in length from 25mm to 80mm. The system also includes the instruments used to implant the screws.

The OIC Intramedullary Screw System is provided non-sterilized by the medical facility prior to implantation.

The screws are manufactured material that conforms to:

ASTM F138, Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673)

The provided text describes a 510(k) premarket notification for a medical device called the "OIC Intramedullary Screw System." It details the device's identification, indications for use, description, and comparison to predicate devices, along with performance testing information.

However, the request asks for specific information regarding acceptance criteria and studies proving the device meets those criteria, particularly in the context of an AI/algorithm-based device. The provided document does not describe an AI/algorithm-based device or any studies related to its performance in classification or diagnostic tasks. Instead, it describes a physical orthopedic implant device (intramedullary screws).

Therefore, I cannot fulfill the request as it is framed, because the document does not contain the information about AI/algorithm performance, ground truth, experts, or MRMC studies. The "Performance Testing" section refers to mechanical testing (torsional, driving torque, axial pullout strength) of the screws themselves, not the performance of an AI system.

To answer your request based on the provided document, the response would be that the document does not contain the information needed to describe the acceptance criteria and study for an AI-based device as requested.

If you are looking for an example of how this information would be presented for a hypothetical AI device based on the structure of your request, I can create a fictional one. Please clarify if that is what you would prefer.

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