(73 days)
The Atlantis Abutment is intended for use with 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: 3i Osseotite NT® Certain™ and 3i Osseotite® Certain™ (parallel Walled) 3.25mm diameter implants.
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.
Also, highly angled abutments (i.e. 30 degrees) on implants with diameters less than 4 mm are intended for the anterior region of the mouth and are not intended for the posterior region due to limited strength of the implant.
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™ Abutments in Zirconia for 3i Certain MicroMini Implant is made of biocompatible material, yttria-stabilized tetragonal zirconia polycrystals (Y-TZP) and meets ISO Standards 6972 & 13356). The abutment screws are made from titanium grade Ti-6A1-V ELI and meets ASTM Standard F-136. The abutment is placed over the implant shoulder and is mounted into the implant with a screw. The abutments are compatible with the 3i Osseotite NT® Certain™ and 3i Osseotite® Certain™ (parallel Walled) 3.25mm diameter implants.
Here's an analysis of the provided text regarding acceptance criteria and study data:
Based on the provided text, this document is a 510(k) summary for a dental abutment, not a study report for a novel AI/software device. Therefore, most of the requested information regarding acceptance criteria for device performance, sample sizes for test/training sets, expert ground truth, MRMC studies, or standalone performance of an algorithm is not applicable or cannot be extracted from this type of document.
The primary purpose of a 510(k) submission is to demonstrate substantial equivalence to a legally marketed predicate device, not typically to present detailed performance studies against specific acceptance criteria in the manner one would for a new diagnostic or AI-powered solution.
Here's what can be inferred or explicitly stated from the provided text, addressing the points where information is available:
1. Table of Acceptance Criteria and Reported Device Performance
- Not Applicable. This document does not present acceptance criteria in terms of performance metrics (e.g., accuracy, sensitivity, specificity) for an AI or software device, nor does it report device performance against such metrics. The "performance" mentioned relates to the physical and material characteristics of the abutment, demonstrating equivalence to predicates.
2. Sample Size Used for the Test Set and Data Provenance
- Not Applicable. No "test set" in the context of an AI/software performance study is mentioned. The submission is about a physical dental abutment.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not Applicable. Ground truth, in the context of an AI/software study, is not established or discussed here for a test set.
4. Adjudication Method for the Test Set
- Not Applicable. Adjudication methods are not relevant to this submission.
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. No MRMC study was conducted or is mentioned, as this is a physical medical device, not an AI/software diagnostic tool requiring human reader improvement assessments.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not Applicable. This device is a physical abutment, not an algorithm.
7. The Type of Ground Truth Used
- Not Applicable. "Ground truth" in the context of performance evaluation for an AI model is not applicable here. The "ground truth" for this device would relate to its physical and material properties meeting established standards and being equivalent to predicates.
8. The Sample Size for the Training Set
- Not Applicable. There is no training set mentioned, as this is not an AI/machine learning device.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. No training set, no ground truth establishment for a training set.
Summary of Relevant Information from the Provided Text:
The document describes a dental abutment and focuses on demonstrating substantial equivalence to previously cleared predicate devices.
- Device: Atlantis™ Abutment in Zirconia for 3i Certain MicroMini Implant.
- Intended Use: To provide support for a prosthetic reconstruction in partially or completely edentulous patients, supporting single and multiple tooth prostheses in the mandible or maxilla. The prosthesis can be cement retained.
- Material: Yttria-stabilized tetragonal zirconia polycrystals (Y-TZP) for the abutment, titanium grade Ti-6Al-V ELI for the screws.
- Standards Met: ISO Standards 6972 & 13356 for the Y-TZP material, ASTM Standard F-136 for the titanium screws.
- Basis for Equivalence: Intended use, material, design, and performance are substantially equivalent to predicate devices: K062069, K063734 (both Atlantis Abutments), and K014235 (3i Certain Implant System).
The "performance" aspect is demonstrated by the device's compatibility with existing implant systems and its material properties meeting specified ISO and ASTM standards, which are implicitly the "acceptance criteria" for its physical characteristics and safety/effectiveness in the context of substantial equivalence. This differs significantly from the performance metrics and studies typically associated with AI/software medical devices.
§ 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.)