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ITI One Part octa implants are intended for surgical placement in the maxillary and/or mandibular arches to provide support for prosthetic restorations in edentulous or partially edentulous patients.

ITI one-part octa implants are for use in edentulous jaws in conjunction with barborne superstructure on 4 implants. If ITI one-part implants are splinted with a bar, they can be loaded immediately.

ITI one-part implants can also be used for indications requiring endosseous implants for functional rehabilitation in regions where an ITI two part implant and an Octa abutment would normally be used.

The All-in-O re implants are screw type dental implants made from CP titanium. Grade 4. They are available in various insertion lengths. The implants have the same rough surface as cleared ITI endosseous implants. The transmucosal part has a smooth machined surface to allow for the attachment of epithelial tissue.

The provided document is a 510(k) summary for a dental implant system (ITI Dental Implant System®) seeking substantial equivalence to existing devices. It does not contain information on the acceptance criteria, study details, or performance of an AI/ML powered device. The document is primarily focused on the device description, intended use, and a comparison to predicate devices, which are all traditional medical devices and not AI-based.

Therefore, I cannot extract the requested information from the given text as it pertains to AI/ML device performance.

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