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Nobel Biocare's NobelReplace Hexagonal Implants are endosseous implants 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. The NobelReplace Hexagonal Implants are indicated for single or multiple unit restorations. The NobelReplace Hexagonal Implants can be used in splinted or non-splinted applications. The NobelReplace Hexagonal Implants may be placed immediately and put into immediate function provided that initial stability requirements detailed in the manual are satisfied.

NobelReplace Hexagonal Implants are threaded, root-form dental implants intended for use in the upper and lower jaw arches to support prosthetic devices, such as an artificial tooth, in order to restore esthetics and chewing function to partially or fully edentulous patients.

The NobelReplace Hexagonal Implants are similar in design to the implants cleared under NobelReplace Tapered Conical Connection, K062566. The predicate internal square was changed to internal bexagonal connection.

This document is a 510(k) summary for a medical device called "NobelReplace Hexagonal Implants." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than undergoing extensive clinical trials with pre-defined acceptance criteria for performance metrics like sensitivity, specificity, or accuracy.

Therefore, the provided text does not contain the information requested regarding acceptance criteria and a study proving the device meets them in the context of typical AI/diagnostic device performance studies.

Here's why and what information is available:

1. A table of acceptance criteria and the reported device performance

• Not Applicable. The document is a 510(k) summary for a dental implant. It aims to show that the new implant (NobelReplace Hexagonal Implant) is substantially equivalent in design and intended use to a previously cleared implant (NobelReplace Tapered Conical Connection, K062566).
• The "performance" described relates to the design changes (internal square was changed to internal hexagonal connection) and how these changes do not alter the fundamental safety and effectiveness of supporting prosthetic devices for esthetics and chewing function. There are no performance metrics like sensitivity or specificity because it's a physical implant, not a diagnostic algorithm.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not Applicable. No test set or data of this nature is mentioned or required for this type of device submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not Applicable. No ground truth establishment for a diagnostic test is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not Applicable.

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 is not a diagnostic device that would involve human readers or AI assistance.

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

• Not Applicable. This is a physical implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Not Applicable. For this device, "ground truth" would be related to the established clinical efficacy and safety of the predicate device and the new device's ability to maintain those characteristics through design equivalency.

8. The sample size for the training set

• Not Applicable. No training set is involved for this type of device submission.

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

• Not Applicable.

Summary Pertaining to the Provided Document (KO-73142):

The document is a US FDA 510(k) summary for a dental implant. Its purpose is to demonstrate substantial equivalence to a predicate device, not to present performance data from a clinical study on diagnostic accuracy or AI performance. The key points from the document are:

• Device Name: NobelReplace Hexagonal Implant
• Predicate Device: NobelReplace Tapered Conical Connection (K062566)
• Key Change: The internal connection was changed from a square to a hexagonal design.
• Demonstration of Performance/Equivalence: The submission implies that this design change does not alter the fundamental indications for use or the safety and effectiveness of the device compared to the predicate. The FDA's review and clearance indicate their agreement with this assessment of substantial equivalence.
• Acceptance Criteria (Implied for 510(k)): The "acceptance criteria" in this context are primarily regulatory – demonstrating that the device is as safe and effective as a legally marketed predicate device, and that any technological differences do not raise different questions of safety and effectiveness. This is achieved through detailed device descriptions, comparison tables (which are not in the provided snippet but would be part of a full 510(k)), and potentially mechanical testing (though not explicitly detailed in this short summary) rather than clinical performance metrics for a diagnostic algorithm.

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