(400 days)
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
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Material Compliance | |
| Zirconia Abutment Material | Complies with ISO 13356:2008 – Implants for Surgery – Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP). Specifically: ZrO2+HfO2+Y2O3 > 99.0%, Y2O3: 4.5~5.4%, HfO2 |
§ 872.3630 Endosseous dental implant abutment.
(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)