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Nobel Biocare's NobelActive implants are endosseous implant intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient esthetics and chewing function. Nobel Biocare's NobelActive implants are indicated for single or multiple unit restorations in splinted or non-splinted applications. Nobel Biocare's NobelActive implants may be placed immediately and put into immediate function provided that initial stability requirements detailed in the manual are satisfied.

NobelActive Internal Connection Implants are threaded, root-form dental implants intended for use in the upper and/or lower jaw to support prosthetic devices, such as artificial teeth, in order to restore patient esthetics and chewing function to partially or fully edentulous patients.

NobelActive Internal Connection Implants are similar to predicate SFB implants. The NobelActive Internal Connection Implants differ from the predicate device in trade name and implant/abutment connection.

I am sorry, but the provided text, K071370, focuses on the regulatory clearance of a dental implant, the NobelActive Internal Connection Implant. It describes the device, its indications for use, and confirms its substantial equivalence to a predicate device.

However, the document does not contain any information regarding clinical studies, device performance data, acceptance criteria, ground truth establishment, sample sizes for testing or training, or expert qualifications as requested in your prompt.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided input.

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