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The NBXTM Non-Bridging External Fixator - Shoulder, is used for external fixation, until healing. This device is used for the fixation of open or closed fractures, mal-union, and non-union of the proximal end of the humerus to include sub-capital and/or fractures of the humeral head.

The NBXTM Non-Bridging Fixator – Shoulder is provided sterile. The fixator consists of the body and with its proprietary locking mechanism and a multiple of threaded pins.

This document is a 510(k) summary for the NBX™ Non-Bridging External Fixator - Shoulder. It does not describe an AI/ML device or software. Therefore, the questions related to acceptance criteria, study details, sample sizes, ground truth establishment, expert involvement, or multi-reader multi-case studies, which are typically associated with performance evaluation of AI/ML software, are not applicable to this submission.

The document discusses a traditional medical device (an external fixator) and its substantial equivalence to previously marketed devices. The performance data mentioned ("Non-Clinical performance data: Equivalence to accepted methods of treatment for this products indication of use is covered in other sections of this application") refers to engineering and biocompatibility testing, not clinical studies involving AI performance metrics.

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