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The VariAx 2 Distal Radius System is indicated for the fixation of fractures, osteotomies, nonunions and malunions of the bones of the hand and wrist, including osteopenic bone.

This Traditional 510(k) submission is being supplied to the U.S. FDA to gain clearance to market the new devices of the VariAx 2 Distal Radius System. This line extension consists of anatomically pre-contoured plates for the treatment of simple and complex fractures of the distal radius, together with specialized instrumentation. All new plates are manufactured from CP Ti Grade 2 (Type II anodization) and are available in different sizes and left/right versions. The plates will be provided both non-sterile and sterile-packaged. They will use the well-established SmartLock technology to allow variable angle screw locking. The plates can be used with non-locking and locking VariAx 2 T8 screws. The VariAx 2 T8 screws have been previously cleared under K191412.

The provided text is an FDA 510(k) clearance letter for the Stryker VariAx 2 Distal Radius System. This document does not contain information about software performance, AI algorithms, or any type of study that would involve acceptance criteria for an AI/software device.

The document discusses a physical medical device (bone fixation plates and screws) and primarily relies on non-clinical performance data comparing the new device to previously cleared predicate devices. The performance data listed (engineering assessment, biomechanical tests, MR safety assessment, packaging tests, biocompatibility) are all related to the physical properties and safety of the implantable hardware, not software or AI performance.

Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving a device meets them, as the provided input does not describe such a study or device.

To fulfill your request, you would need to provide a document related to the clearance of a software as a medical device (SaMD) or a device that incorporates an AI/ML component.

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