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The EBI XFIX DFS® OptiROM™ Elbow Fixator external fixation device is intended for use in upper extremity treatment of bone and soft tissue conditions and other bone conditions amenable to treatment by use of the external treatment modality. Possible applications include:
Fracture dislocation with ligamentos instability
Comminuted intra-articular fractures
Post traumatic reconstruction for joint stiffness

The EBI XFIX DFS OptiROM Elbow Fixator has not changed the Indications for Use or fundamental scientific technology of the previous cleared system. The system consists of external fixation components and implantable bone screws. The EBI XFIX DFS OptiROM Elbow Fixator is utilized in the following manner: bone screws are inserted through the patient skin and soft tissue and into the bone. The fixator frame of the EBI XFIX DFS OptiROM Elbow Fixator is attached to the shanks of the bone screws.

The provided 510(k) summary does not contain information about acceptance criteria or a study proving device performance as typically understood in the context of medical devices like AI algorithms or diagnostic tools. This 510(k) is for a mechanical external fixation device, not a software or AI-driven diagnostic product.

Here's a breakdown of why this information is absent and what the document does provide:

• Type of Device: The EBI XFIX DFS® OptiROM™ Elbow Fixator is a mechanical external fixation device used for stabilizing bones in the upper extremity. Such devices are typically evaluated based on their mechanical properties (e.g., strength, durability, biocompatibility of materials), design similarity to predicate devices, and manufacturing processes, rather than diagnostic performance metrics like sensitivity, specificity, or AUC.
• 510(k) Process: For this type of device, the 510(k) clearance process focuses on demonstrating "substantial equivalence" to a legally marketed predicate device. This often involves comparing design, materials, intended use, and fundamental scientific technology. Clinical studies demonstrating diagnostic performance or reader improvement are generally not required for this type of submission unless there are significant technological differences or new safety/effectiveness concerns.

Therefore, the requested information elements (acceptance criteria table, sample sizes for test/training sets, expert ground truth, adjudication methods, MRMC studies, standalone performance, etc.) are not applicable to this specific submission.

What the document does indicate regarding "device performance" (in the context of substantial equivalence):

The document argues for substantial equivalence by stating:

• "The EBI XFIX DFS OptiROM™ Elbow Fixator is substantially equivalent to the following predicate EBI and competitive devices."
• "The components of the EBI XFIX DFS OptiROM Elbow Fixator are fabricated from the same types of materials as the components of the currently marketed EBI XFIX DFS Joint Fixator."
• "The bone screw clamps... are designed for attachment to the bone screws," similar to the predicate.
• "The Distractor... is designed to provide the surgeon the ability to compress or distract the bone of the patient for optimal treatment," similar to the predicate.
• "It is substantially equivalent to the predicate devices in regards to intended use, materials and function."

In essence, the "proof" that this device meets acceptance criteria is its demonstration of substantial equivalence in design, materials, and function to previously cleared devices. There is no mention of a formal study with statistical endpoints to demonstrate improvement in human performance or standalone diagnostic accuracy because the device's function does not involve diagnostic interpretation.

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