(81 days)
The Atlantis Abutment is intended for use as an accessory to an endosseous implant to support a prosthetic device in a partially or completely edentulous patient. It is intended for use to support single and multiple tooth prosthesis, in the mandible or maxilla. The prosthesis can be cement retained to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant.
This device is compatible with the following manufacturers' implant systems: Zimmer Dental, Nobel Biocare, 3i, Lifecore, Sterngold, Implamed, Innova and BioHorizons.
Please note: This device may be used in an early load situation, but is dependent on the specific implant system and protocol used by the dental professional.
The devices covered in this submission are abutments which are placed into the dental implant to provide support for a prosthetic restoration. The subject abutments are indicated for cemented restorations.
The Atlantis™ Abutment in Zirconia is made of the biocompatible material, yttriastabilized tetragonal zirconia polycrystals (Y-TZP) (Meets ISO standards 6872 & 13356) and the abutment screw is made from Titanium grade Ti-6A1-4V ELI (Meets ASTM Standard F-136).
This submission focuses on a dental implant abutment, specifically the Atlantis™ Abutment in Zirconia, and its substantial equivalence to previously marketed devices. The document does not describe a study involving a device with acceptance criteria and reported device performance in the context of an AI/software device. Instead, it is a 510(k) pre-market notification for a physical medical device.
Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details are not applicable to this document. The document is for a physical dental device, not a software or AI-driven diagnostic or treatment device.
However, I can extract the relevant information about the device itself and its deemed equivalence:
Device Description and Equivalence:
- Device Name: Atlantis™ Abutment in Zirconia (Trade Name), Endosseous dental implant abutment (Common Name and Classification Name).
- Intended Use: To be placed into a dental implant to provide support for a prosthetic reconstruction in a partially or completely edentulous patient. It supports single and multiple tooth prostheses in the mandible or maxilla, with the prosthesis cement-retained to the abutment. The abutment screw secures the abutment to the endosseous implant.
- Material: Yttria-stabilized tetragonal zirconia polycrystals (Y-TZP) for the abutment (Meets ISO standards 6872 & 13356), and Titanium grade Ti-6A1-4V ELI for the abutment screw (Meets ASTM Standard F-136).
- Predicate Devices:
- Basis for Substantial Equivalence: The Atlantis™ Abutment in Zirconia is considered substantially equivalent in intended use, material, design, and performance to the listed predicate devices.
- Compatibility: This device is compatible with implant systems from Zimmer Dental, Nobel Biocare, 3i, Lifecore, Sterngold, Implamed, Innova, and BioHorizons.
Regarding the specific questions, and why they are not applicable here:
- A table of acceptance criteria and the reported device performance: This document is a 510(k) summary for substantial equivalence, not a performance study report for an AI or diagnostic device. There are no "acceptance criteria" in the sense of performance metrics (e.g., sensitivity, specificity, AUC) for a physical abutment in this context. The acceptance is based on meeting the defined "Intended Use" and demonstrating equivalence in "material, design and performance" to predicate devices, which is generally done through mechanical testing and material characterization, not clinical performance metrics presented in a table like this.
- Sample size used for the test set and the data provenance: Not applicable. There is no "test set" of data as would be used for an AI/software device.
- Number of experts used to establish the ground truth... and qualifications: Not applicable. Ground truth as understood in AI/software evaluation (e.g., expert labels for images) is not relevant for a physical dental abutment’s 510(k) submission.
- Adjudication method: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done...: Not applicable. MRMC studies are for evaluating diagnostic accuracy, not for a physical implant component.
- If a standalone performance was done: Not applicable in the context of AI. The "performance" assessment for this physical device would involve things like fatigue testing, biocompatibility, and fit, which are demonstrated to be equivalent to predicates rather than a standalone performance metric reported here.
- The type of ground truth used: Not applicable. For a physical device like this, the "ground truth" for regulatory clearance is that it meets engineering specifications and is equivalent to previously cleared devices.
- The sample size for the training set: Not applicable. No "training set" for a physical device.
- How the ground truth for the training set was established: Not applicable.
In summary, the provided text describes a regulatory submission for a physical dental implant component, not a software or AI-driven device. Therefore, the questions designed to probe the evaluation of an AI-driven device are largely not relevant to this document.
§ 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.)