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The EZ-Fix™ Proximal Humeral Intramedullary Rod is an internal skeletal fixation device indicated for intramedullary use to stabilize fractures of the proximal humerus.

The EZ-Fix™ Proximal Humeral Intramedullary Rod is an internal skeletal fixation device indicated for intramedullary use to stabilize fractures of the proximal humerus. The device has been engineered for ease of use and the ability to accommodate a wide variety of proximal humeral fractures. The EZ-Fix™ Humeral Rod is cylindrical and available in 9mm, 11mm, 13mm and 15mm diameters and is approximately 155mm in length. Proximally there are four screw holes for capturing and stabilizing humeral head fragments. Most proximally, the EZ-Fix™ Humeral Rod accepts a 6.5mm cannulated screw. Two holes, one 60 degrees anterior and one 60 degrees posterior from the lateral side, accept 5mm bone screws. The most distal hole also accepts a 5mm bone screw and is aligned laterally with the most proximal screw hole. In addition to the four proximal holes in the 11mm. 13mm and 15mm rods, there are four suture holes proximally to attach soft tissues. The EZ-Fix™ Humeral Rod is tri-sloted distally allowing the rod to collapse and accommodate anatomical variances. These three slots are of different lengths and extend from the distal end of the rod to just below the four proximal screw holes. The EZ-Fix™ Humeral Rod has shallow grooves situated below the screw holes and extending lengthwise for ease of implantation without reaming, enhanced flexibility and rotational stability. An insertion/extraction instrumentation attachment hole is located in the proximal end of the rod. This threaded hole is protected by a titanium alloy (TI-6AL-4V) capscrew. disallowing soft tissue ingrowth post implantation. The EZ-Fix™ Humeral Rod is titanium alloy (TI-6AL-4V) for biocompatibility and strength.

The provided text describes a medical device, the EZ-Fix™ Proximal Humeral Intramedullary Rod System, and its substantial equivalence to predicate devices. However, the document does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria in the context of an AI/human-in-the-loop system.

Instead, the document focuses on:

• Device Description: The physical characteristics and intended use of the EZ-Fix™ rod.
• Comparison to Predicate Devices: How the EZ-Fix™ is similar to other legally marketed intramedullary rods in terms of materials, geometry, intended use, and fixation methods.
• Testing: It states that the device was tested based on ASTM standards for intramedullary rods, and the results "proved the rods to be of sound design" and "identical to those obtained on the referenced equivalent."
• Sterilization and Packaging: Details on how the device is sterilized and packaged.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets them, as the provided text pertains to a traditional medical device submission (PMA/510(k) equivalent) and not a study assessing AI performance or human-AI interaction.

If you have a different document that details an AI device's performance study, please provide that.

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