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The Synthes 4.5 mm VA-LCP Curved Condylar System is intended for buttressing multi-fragmentary distal femur fractures including: supracondylar, intra-articular and extra-articular condylar fractures, periprosthetic fractures, fractures in normal or osteopenic bone, and non-unions and malunions.

The Synthes 4.5 mm VA-LCP Curved Condylar System consists of plates and screws that offer a screw to plate variable angle locking construt. The 4.5 mm VA-LCP Curved Condylar System enhances fracture fixation by providing the flexibility to lock screws in trajectories that can diverge from the central axis of the plate hole.

The provided text is a 510(k) summary for the Synthes 4.5 mm VA-LCP Curved Condylar System, outlining its device name, intended use, and classification. It also includes the FDA's letter of substantial equivalence. However, this document describes a medical device (bone fixation system) and not an AI/algorithm-driven device. As such, it does not contain information about acceptance criteria, device performance metrics (such as sensitivity, specificity), sample sizes for test/training sets, ground truth establishment, expert adjudication, or MRMC studies, which are all specific to the evaluation of AI/ML models.

Therefore, I cannot extract the requested information as it is not present in the provided text.

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