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Nobel Biocare's Zygoma implants are endosseous dental implants intended to be surgically placed in the bone of the upper jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore patient esthetics and chewing function. The Zygoma Implants may be put into immediate function provided that stability requirements detailed in the directions for use are satisfied.

Nobel Biocare's NobelZygoma 45° implants are threaded, root-form titanium dental implants intended to extend through the maxillary sinus into the Zygomaticus bone to support prosthetic devices, such as artificial teeth, in order to restore chewing function.

The NobelZygoma 45° implants are available in lengths between 30 and 52.5 mm and have a 4.5 mm external hex connection. They are made of commercially pure titanium and have the Nobel Biocare TiUnite surface treatment.

This document is a 510(k) premarket notification for a dental implant, the NobelZygoma 45°. It does not describe an AI/ML powered device, nor does it present clinical performance data in the typical sense of acceptance criteria for diagnostic accuracy or efficacy. Instead, it focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing and shared characteristics.

Therefore, the requested information elements related to AI/ML device performance, human readers, ground truth establishment, and training/test set details cannot be extracted from this document in their typical form.

However, I can extract and present the available information regarding the device's technical specifications and how its performance was evaluated to demonstrate substantial equivalence, which is the primary "acceptance criterion" for a 510(k) submission.

1. Table of Acceptance Criteria and Reported Device Performance (Focus on Substantial Equivalence and Non-Clinical Testing for Dental Implants)

For this type of device, "acceptance criteria" are generally tied to demonstrating that the new device is as safe and effective as a legally marketed predicate device. The primary "study" is a comparative performance test.

2. Sample Size Used for the Test Set and Data Provenance:

• Test Set Sample Size: Not explicitly stated as a numerical value for a typical clinical test set. The "test set" in this context refers to the samples of the NobelZygoma 45° device and the predicate device used for mechanical fatigue testing. The document states "Both the subject and predicate device were tested under identical conditions," implying multiple units were tested to determine the fatigue limit, but the exact number is not provided.
• Data Provenance: The document is a regulatory submission for a dental implant manufactured by Nobel Biocare AB (Sweden) and submitted by Nobel Biocare USA LLC (USA). The testing described is non-clinical (mechanical), performed to demonstrate the device's physical properties.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

• This concept is not applicable as this is a non-clinical, mechanical device. "Ground truth" for a dental implant's mechanical properties is derived from standardized testing methods (e.g., ISO 14801), not expert consensus in the diagnostic sense.

4. Adjudication Method (for the test set):

• Not applicable as this is a mechanical device with non-clinical performance data, not subject to human adjudication for a test set.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• Not applicable. This document is for a physical medical device (dental implant), not an AI/ML-powered diagnostic or assistive tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not applicable. This document is for a physical medical device (dental implant).

7. The type of ground truth used:

• For the mechanical performance testing (fatigue limit), the "ground truth" is defined by the objective measurements obtained through the standardized mechanical test method (modified ISO 14801).

8. The sample size for the training set:

• Not applicable. This document is for a physical medical device (dental implant), not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established:

• Not applicable. No training set is involved.

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