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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

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