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Indicated to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed. Screws are intended for single use only.

The OsteoMed Orthodontic Screw System is comprised of screws in diameters of 1.2mm to 2.0mm in thread lengths of 4.0mm to 8.0mm. The screws are made from titanium alloy. Pilot Drills and screwdrivers will also be a part of the system.

This document is a 510(k) premarket notification for the OsteoMed Orthodontic Screw System. It is a regulatory submission to the FDA to demonstrate substantial equivalence to legally marketed predicate devices, not a study evaluating the performance of AI. Therefore, the provided text does not contain the information requested in your prompt regarding acceptance criteria, study design, sample sizes, expert involvement, or adjudication methods for an AI device.

The document discusses:

• Device Proprietary Name: OsteoMed Orthodontic Screw System
• Device Common Name: Bone Screw
• Intended Use: To provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed.
• Materials: Titanium alloy
• Predicate Devices: Straumann Ortho Implant (K982509) and Nobel Biocare Inplant Orthodontic Anchor System (K000643).
• Basis for Equivalence: Similarities in intended use, material, design, and operational principle to the predicate devices.
• Conclusion: OsteoMed believes the device does not raise new safety or effectiveness issues due to these similarities.

In summary, there is no information in the provided text to answer your questions about acceptance criteria and an AI study. This document is a regulatory submission for a physical medical device, not an AI software.

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