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The LORRAINE 2.5/3.5mm Distal Humerus System is indicated for intra-articular or extra-articular fractures of the distal humerus, supracondylar fractures, osteotomies, and non-unions. Longer plates may be used for distal humerus fractures with diaphyseal extension.

The Bonebridge Osteosynthesis Plating System is intended for treating fractures of various bones. It consists of plates, locking and non-locking screws for fixation and corresponding instruments. The plating system is further subdivided into variants/types based on the anatomical location of the fracture. The subject LORRAINE 2.5/3.5mm Distal Humerus System is a variant of the Bonebridge Osteosynthesis Plating System.

The plates are primarily manufactured from stainless steel (ISO 5832-1, ASTM F138, or ASTM F139) and include Titanium Inlay Clips (TICs) made from pure titanium (ASTM F67 or ISO 5832-2). The screws are manufactured entirely from stainless steel (ISO 5832-1, ASTM F138, or ASTM F139).

All materials used are biocompatible, corrosion-resistant and nontoxic in a biological environment. Surgical instruments are made of stainless steel (ASTM F899, ISO 7153-1, ISO 5832-1, and ASTM F138/139), medical grade PEEK, medical grade EPDM terpolymer, or medical grade silicone. All plates are sterilized with gamma irradiation and delivered sterile. Screws and instruments are delivered non-sterile. Devices supplied in a non-sterile condition must be cleaned and steam sterilized prior to surgical use. Non-clinical testing has demonstrated the implants are MR Conditional.

The provided document is a 510(k) summary for the LORRAINE 2.5/3.5mm Distal Humerus System. It describes the administrative information, device classification, predicate devices, indications for use, device description, and a summary of non-clinical tests.

However, this document does NOT contain information about any study involving Artificial Intelligence (AI) or machine learning, human readers, or image-based diagnostics. The device described is a metallic bone fixation appliance, specifically plates and screws, used for orthopedic applications (fractures, osteotomies, non-unions of the distal humerus).

Therefore, I cannot extract the information required by your prompt, such as:

• Acceptance criteria and reported device performance related to AI/ML.
• Sample sizes for test or training sets, data provenance, expert ground truth establishment, or adjudication methods, as these relate to studies involving AI/ML performance.
• Multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone algorithm performance.
• Types of ground truth (expert consensus, pathology, outcomes data) in the context of AI/ML.

The "studies" described in the document are non-clinical tests related to the physical device itself:

• Sterilization validation: Ensuring the device can be properly sterilized.
• Packaging validation: Ensuring the sterile packaging integrity.
• Biocompatibility: Assessing the safety of the materials in a biological environment.
• Mechanical testing: Evaluating the strength and stiffness of the plates and screws, comparing them to predicate devices. This involves mechanical stresses, not data analysis or human-in-the-loop performance.
• MRI safety: Determining if the device is safe for patients undergoing MRI scans.

All these tests are standard for orthopedic implants and are designed to demonstrate the physical and material properties and safety of the device, not an AI or data-driven component.

Therefore, it is impossible to answer your request based on the provided text, as the text describes a physical medical device (orthopedic implant) and not an AI/ML powered device.

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