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Synthes 4.0 Adjustable Clamp for Distal Radius Fixator -MR Safe is part of a construct intended for the stabilization of fractures of the distal radius.

Synthes Distal Radius Fixator consists of frame elements that form a construct intended to treat fractures of the distal radius. The Distal Radius Fixator provides stabilization of fractures via pins (Schanz screws) inserted proximally and distally to a fracture and connected by an external bridging frame consisting of two 4.0 mm Adjustable Clamps, a carbon fiber rod and two protective end caps. This device is intended for use in the MR environment. The Distal Radius Fixator is available as a complete sterile assembly or as individual, nonsterile components.

The provided text does not contain information about acceptance criteria or a study proving device performance as it pertains to AI/ML or diagnostic performance. Instead, it is a 510(k) summary for a medical device (Synthes 4.0 mm Adjustable Clamp for Distal Radius Fixator - MR Safe) and the FDA's clearance letter for it.

The document focuses on:

• Device Description and Intended Use: Stabilization of distal radius fractures.
• MR Safety: The key aspect highlighted, implying testing for compatibility with an MR environment.
• Substantial Equivalence: The primary basis for FDA clearance, comparing it to a legally marketed predicate device.

To answer your specific questions related to acceptance criteria, AI/ML performance, and ground truth, that information would typically be found in a study report for a diagnostic or AI-powered device, which is not present in this document.

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