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The G3™ Active Plate® Miniature System is intended for fracture fixation in patients 18 years of age and older requiring stabilization of mal-unions, osteotomies and repair of closed and open fractures in small bones. The system is indicated for the fixation of small bone fractures including, but not limited to, fractures of the hand, foot, wrist and ankle.

The G3™ Active Plate® Miniature System is a straight plate and locking screw system intended to be used for fracture fixation of the hand and foot. All implantable components are manufactured from medical grade titanium alloy (Ti6Al4V-ELI), medical grade cobalt chrome alloy (Co-28Cr-6Mo) and silicone elastomer in the subject device.

The plate has 8 holes. The plates incorporate link elements, which are constrained within the plate and embedded in an elastomer sheath that is bonded to both the link element. Once locking screws are inserted, the active elements allow for independent controlled axial translation of the screws. The screws are 1.5 mm diameter and come in lengths ranging from 8 mm to 24 mm.

This document describes a medical device, the G3™ Active Plate® Miniature System, and its substantial equivalence to predicate devices, rather than outlining acceptance criteria and a study to prove a device meets those criteria in the context of an AI/ML medical device.

Therefore, I cannot provide the information requested in the specified format regarding acceptance criteria and performance studies. The provided text is a 510(k) summary for a bone fixation system, which focuses on demonstrating substantial equivalence to previously cleared devices through material, geometric, and mechanical performance comparisons, not a clinical study with an AI algorithm.

Here's why the requested information cannot be extracted from the provided text:

• No Acceptance Criteria for an AI Device: The document is about a physical bone fixation plate and screws, not an AI/ML algorithm. Therefore, there are no acceptance criteria related to AI performance metrics (e.g., sensitivity, specificity, AUC).
• No Reported Device Performance for an AI Device: Similarly, there is no performance data for an AI algorithm because the device itself is a mechanical implant.
• No Test Set/Ground Truth/Experts/Adjudication/MRMC/Standalone Study: These are all concepts relevant to the evaluation of AI/ML diagnostic or prognostic tools. The provided document does not discuss any such studies or evaluations.
• No Training Set Information: There is no AI training set because this is not an AI/ML device.

In summary, the provided text does not contain the type of information related to AI/ML device acceptance criteria and performance studies that your questions are designed to extract.

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