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The Vilex X-Fix is intended for external fixation with the following indications:

1. Stabilization of Fractures & Osteotomy
2. Rear & Mid-foot Foot Arthrodesis
3. Adult and Pediatric Leg Lengthening
4. Correction of Bone Deformity in Upper & Lower Extremities.

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The provided text is a 510(k) summary for the Vilex External Fixation System, X-Fix. This document is for a medical device (an external fixation system), not a diagnostic AI software. Therefore, the questions related to the acceptance criteria for AI/ML performance, study design for AI models, ground truth establishment, expert adjudication, and sample sizes for training/test sets are not applicable to this submission.

The 510(k) summary focuses on demonstrating substantial equivalence to predicate devices based on design, materials, and intended use, rather than on performance derived from a study involving AI or machine learning. The acceptance criteria for such a device would typically relate to mechanical performance (e.g., strength, durability, biocompatibility) and clinical effectiveness for its stated indications, usually supported by a comparison to existing devices and bench testing, not by AI performance metrics.

Therefore, I cannot provide the requested information as it pertains to AI/ML device performance. The document focuses on regulatory approval for a physical medical device.

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