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The Nobel Direct 3.0mm implant is indicated for use in the treatment of missing maxillary lateral incisors or the mandibular central and lateral incisors to support prosthetic devices, such as artificial teeth, in order to restore chewing function in partially edentulous patients. The NobelDirect 3.0 Implants may be put into immediate function provided that stability requirements detailed in the manual are satisfied.

Mandible central and lateral incisors must be splinted if using two or more 3.0mm implants adjacent to one another.

Nobel Biocare's NobelDirect 3.0 Implant is a threaded one-piece root form endosseous implant with an integrated abutment designed for one-stage surgical procedures. The NobelDirect 3.0 is 3.0mm in diameter and available in lengths of 13mm and 15mm.

The provided text is a 510(k) summary for a dental implant, K070857 NobelDirect 3.0 - Immediate Load. A 510(k) submission primarily demonstrates substantial equivalence to a predicate device, focusing on device description, indications for use, and a comparison to the predicate. It does not typically include detailed performance study results, acceptance criteria, or an in-depth analysis of AI components because it's for a traditional medical device, not an AI/ML-driven diagnostic or therapeutic device.

Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth for AI model training. These elements are relevant for AI/ML device submissions, which this is not.

The document only provides the following:

1. Device Information:

• Submitted by: Herbert Crane, Nobel Biocare USA LLC
• Device Name: NobelDirect 3.0 - Immediate Load
• Classification Name: Endosseous Dental Implant (21 CFR 872.3640)
• Legally Marketed Device(s) (Predicate): NobelDirect (K031345)
• Device Description: A threaded one-piece root form endosseous implant with an integrated abutment, 3.0mm in diameter, available in 13mm and 15mm lengths.
• Indications for Use: For missing maxillary lateral incisors or mandibular central and lateral incisors to support prosthetic devices in partially edentulous patients. May be put into immediate function if stability requirements are met. Mandible central and lateral incisors must be splinted if using two or more 3.0mm implants adjacent to one another.

This submission is a regulatory approval for a physical dental implant, not a software or AI-driven diagnostic device.

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