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The Eleganz™ Fusion Screw System is indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the size of the device. Examples include scaphoid and other carpal fractures, metacarpal and phalangeal fusions, and bunionectomies.

The screws are not intended for interference or soft tissue fixation.

The EleganzTM Fusion Screw System includes screws for bone fixation and a set of instruments used for screw site preparation and delivery. The device is offered in two non-sterile trays that contain the screw, Kirschner wire, bone preparation instrumentation and a driver.

The screws and Kirschner wires are used to stabilize a fracture, osteotomy site, or joint so that healing and fusion may occur which achieves its intended function.

The screws are available in solid and cannulated versions and are made from Ti6Al4V alloy. They range from 8-50 mm in length. The outer diameter is tapered, varying from 2.5 mm at the tail to 2.0 mm (solid) or 2.25 mm (cannulated) at the tip. The Kirschner wires are 316 stainless steel.

The instrumentation includes a drill, driver handle, driver bit, depth gauge / countersink, Kirschner wire, and ball and socket reamers. The drills and driver components are cannulated. The drills are offered in two lengths. The driver handle is used with the driver bit to insert the screw as well as with the drill for hand drilling. The depth gauge measures the Kirschner wire to determine its depth in the bone. The countersink has cutting flutes for easier entry into the intramedullary canal. The ball and socket reamers create a spherical radius on joint surfaces for better bony fusion.

The provided text is an FDA 510(k) clearance letter for the "Eleganz Fusion Screw System." This document primarily focuses on the regulatory clearance process for a bone fixation device, asserting its substantial equivalence to previously cleared predicate devices based on design, materials, and intended use.

Crucially, the document explicitly states under "Non-Clinical and/or Clinical Tests Summary & Conclusions":

"No clinical tests were submitted, referenced or relied for the 510(k)."

This means that the clearance was not based on studies demonstrating the device meets acceptance criteria related to its performance in a clinical setting, such as the accuracy of an AI algorithm or the improvement of human readers with AI assistance. Instead, it relies on non-clinical testing (e.g., mechanical properties) and comparison to predicate devices.

Therefore, I cannot provide the detailed information requested in your prompt regarding acceptance criteria, study findings, sample sizes, expert ground truth establishment, or MRMC studies, as this information is not present in the provided FDA 510(k) clearance letter. The questions you've asked are typically relevant to the clearance of AI/ML-enabled medical devices, where performance metrics and human-in-the-loop studies are often critical for demonstrating safety and effectiveness. The Eleganz Fusion Screw System is a physical orthopedic implant, and its clearance pathway did not necessitate the types of studies you are inquiring about.

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