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Diamond Orthopedic Bone Fixation Screws and Pins are intended to be used as fixation implants for bone fractures, joint fusion, bone reconstruction, or as guide pins for insertion of other implantable devices.

Diamond Orthopedic Bone Screws (cortical screws, cancellous screws, and headless compression screws) are available in thread diameters ranging from 1.5mm to 7.3mm, lengths ranging from 6mm to 180mm, and either solid or cannulated, and made of stainless steel or titanium.

Diamond Orthopedic External Fixation Screws are available in thread diameters ranging from 4mm to 6mm, lengths ranging from 60mm to 250mm, and thread lengths ranging from 18mm to 80mm, and made of stainless steel or titanium.

Diamond Orthopedic Kirschner Wires are available in wire diameters ranging from 1.0mm to 2.5mm, in lengths ranging from 100mm to 150mm, 0.7mm to 1.6mm, in lengths ranging from 101.6mm to 304.8mm and are partially or completely threaded, or smooth. Made of stainless steel or titanium.

Diamond Orthopedic Guide Wires are available in wire diameters ranging from 0.8mm to 2.8mm, in lengths ranging from 100mm to 450mm, are partially threaded or smooth. Made of stainless steel, titanium, or cobalt.

Diamond Orthopedic Steinmann Pins are available in wire diameters ranging from 2mm to 4.7mm, in lengths ranging from 228.6mm to 304.8mm, are completely threaded, or smooth. Made of stainless steel or titanium.

This document is a 510(k) summary for medical devices (bone fixation screws and pins) and does not contain information about software or AI device performance. Therefore, I cannot extract the requested information regarding acceptance criteria and study details for such a device.

The provided text describes:

• Device name: Diamond Orthopedic Bone Fixation Screws and Pins
• Regulatory classification: Class II, for smooth or threaded metallic bone fixation fasteners
• Indications for Use: Fixation implants for bone fractures, joint fusion, bone reconstruction, or as guide pins for insertion of other implantable devices.
• Predicate device: Medical Facet Bone Fixation Screws and Pins (K112727)
• Device description: Details on sizes, materials (stainless steel, titanium, cobalt), and types of screws, wires, and pins.
• Non-Clinical Testing: States that the subject device is identical in geometry and manufacturing to the predicate, so no new mechanical performance testing was performed related to bone fixation itself. Instead, validation was done for sterilization, shelf life, LAL testing, and packaging.
• Substantial Equivalence: Asserts that the modified device has the same intended use, indications for use, principles of operation, and technological characteristics as the predicate, raising no new questions of safety or effectiveness.

None of the above pertains to a study demonstrating the performance of a software or AI device against specific acceptance criteria.

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