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GC Aadva™ Abutments -Zirconia - Bo Ac Bh Sv are dental implant abutments for use with partially or fully edentulous patients to restore chewing function by attachment to a dental implant fixture placed in the maxilla or mandible. Each abutment is accompanied by a screw in order to engage corresponding dental implant fixture.

The "GC Aadva™ Abutments – Zirconia – Bo Ac Bh Sv" are abutments which are placed into a dental implant to provide support for a prosthetic restoration. The subject abutments are indicated for use with the following implant fixtures: Institut straumann AG Bone Level Implant NC and RC, Nobel Biocare AB NobelActive NP and RP, BioHorizons Tapered Internal Implant, and Zimmer Dental Inc. Tapered Screw-Vent. The abutment components comply with ISO 13356:2008 – Implants for Surgery – Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP). The abutments are mounted into the implant with a screw made of Titanium grade Ti-6Al-4V, which meets the requirements of ISO : 5832-3.

The provided document describes the "GC Aadva™ Abutments – Zirconia – Bo Ac Bh Sv" and its substantial equivalence to predicate devices, rather than a study proving the device meets specific performance criteria in the context of an AI/human-in-the-loop system. This application is for a physical medical device (dental abutments) and thus the questions related to AI performance, expert ground truth, sample sizes for training/test sets, and adjudication methods are not applicable.

However, I can extract the acceptance criteria and the performance testing conducted for this device.

Acceptance Criteria and Device Performance for GC Aadva™ Abutments – Zirconia

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance:

The document states that "Static and fatigue testing was conducted on the 'worst case scenario' implant-abutment combination assemblies". It does not specify the exact number of samples tested but implies a representative selection based on a "worst case" model. The data provenance is not explicitly stated as country of origin, but the testing was conducted by or for the manufacturer (GC CORPORATION, Tokyo, Japan) to comply with FDA guidance and ISO standards. It is implied to be prospective testing for regulatory submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. This is a physical device, and its performance is evaluated through engineering and materials testing (static and fatigue tests) against established international standards (ISO 13356, ISO 5832-3, ISO 14801) and FDA guidance, not by expert interpretation of data.

4. Adjudication method for the test set:

Not applicable. Data is generated through physical tests, not interpreted by experts requiring adjudication.

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 a physical device, not an AI or imaging diagnostic tool.

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

Not applicable. This is a physical device.

7. The type of ground truth used:

The ground truth used for this device is based on established international standards and regulatory guidance for medical device performance, specifically:

• ISO 13356:2008 for ceramic materials (Y-TZP Zirconia)
• ISO 5832-3 for titanium alloys (Ti-6Al-4V)
• ISO 14801:2007 (or its contemporary version) for dynamic fatigue testing of endosseous dental implants
• FDA's Guidance Document for Dental Implants

These standards define the acceptable material properties and mechanical performance thresholds.

8. The sample size for the training set:

Not applicable. This is a physical device, not an AI system that requires a training set.

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

Not applicable. This is a physical device.

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