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NobelActive GoldAdapt Abutment is a pre-manufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.

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 nonsplinted 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.

The NobelActive GoldAdapt Abutment is an endosseous dental implant abutment intended to be used with the NobelActive implant system. The NobelActive GoldAdapt is made of gold alloy and comes in engaging and non-engaging styles.

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.

The provided text is a 510(k) summary for the NobelActive GoldAdapt Abutment and NobelActive Internal Connection Implant. This document focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study with acceptance criteria and device performance as would be found for a novel device or AI/software as a medical device (SaMD).

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set information is not present in the provided text.

The document states that the device is "substantially equivalent" to legally marketed predicate devices, which is the core of a 510(k) submission for this type of device (dental implant components). The studies typically performed for such devices are focused on mechanical strength, biocompatibility, and fit, often by comparing them to the predicate devices or established standards, rather than clinical performance metrics in the way a diagnostic AI would be evaluated.

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