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Smith & Nephew's MAVERICK and MAVERICK Mini External Fixation System is intended to be used for temporary stabilization of the long bones, feet, pelvis, and wrist.

The indications for the Smith & Nephew MAVERICK Mini External Fixation System are the following:

• Open and closed fracture fixation
• Bony or soft tissue deformities

The subject of this premarket notification is the MAVERICK Mini External Fixation System. The system is an external fixation system that consists of various components used in the management of pelvic, feet, wrist, and long bone fractures and reconstructive and corrective orthopedic surgery. The system consists of stainless steel bone pins, composite and titanium bars, and titanium clamps. These components can be combined to build a frame which is appropriate for each specific application.

This is a medical device submission, specifically a Pre-Market Notification (510(k)) for the MAVERICK Mini External Fixation System. It describes the device, its intended use, and states that it has been determined to be substantially equivalent to previously cleared predicate devices.

However, this document does not contain information regarding acceptance criteria and a study proving a device meets those criteria in the context of AI/ML or diagnostic performance. The "performance testing" section refers to bench testing for mechanical properties (e.g., torsional grip strength, axial grip strength, rigidity testing) typical for orthopedic fixation devices, not a study evaluating diagnostic accuracy, sensitivity, specificity, or human-in-the-loop performance which would require the acceptance criteria and study details you've outlined.

Therefore, I cannot provide the requested information for acceptance criteria and a study that proves the device meets those criteria based on the provided text, as this document focuses on mechanical substantial equivalence for an external fixation system.

The questions you've asked are typically relevant for submissions of AI/ML-driven diagnostic devices or imaging analysis software, which require clinical performance studies with specific statistical endpoints and ground truth establishment. This document is for a traditional medical device (an external fixation system).

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