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The Emerge Medical IM Nail System is intended to provide temporary stabilization in long bones including the femur, tibia and humerus of various types of open or closed fractures including malunions, nonunions (pseudoarthrosis), correction osteotomy including malalignment, pathologic fractures, impending pathologic fractures, and tumor resections of specific bones.

Specific Femoral indications may include supracondylar fractures, including those with intra-articular extension, Ipsilateral femur fractures proximal to a total knee arthroplasty, and fractures distal to a hip joint.

Specific Humeral indications according to AO classification may include Type A-Fractures, dislocated, Type B Fractures, dislocated, Type C-Fractures, with intact calotte, or Humeral Fractures according to Neer-Classification.

The System consists of titanium alloy intramedullary (IM) nails locking screws and end caps. The rigid, cannulated IM nails are inserted into the medullary canal and available in a variety of styles and lengths with proximal and distal holes for locking screws.

The provided document is a 510(k) premarket notification for the Emerge Medical IM Nail System. It describes the device, its indications for use, and a comparison to predicate devices. However, this document does not describe acceptance criteria for software performance or a study proving that a device meets such criteria.

The "Performance Data" section explicitly states: "Clinical data were not needed to demonstrate substantial equivalence." Instead, it refers to "Dimensional analysis and mechanical testing (ASTM F-1264 and ASTM F-543)" for demonstrating that the device performs as well as or better than the predicate device. This pertains to the physical and mechanical properties of the intramedullary nails, screws, and end caps, not to any software or algorithmic performance.

Therefore, I cannot provide the requested information about acceptance criteria for device performance, especially those related to a study proving such criteria are met by a software-driven or AI-enabled device. The document describes a physical medical device (intramedullary nail system).

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