(146 days)
The Atlantis Abutment is intended for use with an endosseous implant to support a prosthetic device in a partially or completely endentulous patient. It is intended for use to support single and multiple tooth prosthesis, in the mandible or maxilla. The prosthesis can be cemented or screw 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:
The titanium and zirconia abutments are compatible with the 3.8mm, 4.5mm, 5.5mm, and 6.5mm Keystone Genesis Tapered and Straight Implants.
The Atlantis™ Crown Abutment in Zirconia is intended for use with an endosseous implant to function as a substructure that also serves as the final restoration, in partially or completely edentulous patients. The prosthesis is screw retained. The abutment screw is intended to secure the crown abutment to the endosseous implant.
This device is compatible with the following manufacturers' implant systems:
the 3.8mm, 4.5mm, 5.5mm, and 6.5mm Keystone Genesis Tapered and Straight 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.
Highly angled abutments on small diameter implants are intended for the anterior region of the mouth only.
The devices covered in this submission are abutments which are placed into the dental implant to provide support for a prosthetic restoration. The titanium and zirconia abutments are indicated for cemented or screw retained restorations. The crown abutment in zirconia is indicated for screw retained restorations. The titanium Atlantis™ Abutment for Keystone Genesis Implant and abutment screw are made of Titanium grade Ti-6A1-4V ELI (meets ASTM Standard F-136) for the 3.8mm, 4.5mm, 5.5mm and 6.5mm sizes. In addition, the zircoina Atlantis™ Abutment for Keystone Genesis Implant and the Atlantis™ Crown Abutment in Zirconia for the 3.8mm. 4.5mm. 5.5mm and 6.5mm sizes are made of biocompatible material, yttriastabilized tetragonal zirconia polycrystals (Y-TZP) and meets ISO Standards 6972 & 13356). Zirconia may have variation in shade. The titanium and zirconia abutments are placed over the implant shoulder and are mounted into the implant with a titanium screw.
This document describes a 510(k) premarket notification for the Atlantis™ Abutment and Atlantis™ Crown Abutment in Zirconia for Keystone Genesis Implant. This is a medical device submission, and therefore, the information provided is focused on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove performance against specific acceptance criteria for a novel device.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
For this type of 510(k) submission, the "acceptance criteria" are typically defined by demonstrating that the new device is "substantially equivalent" to legally marketed predicate devices. This equivalence is primarily shown through comparisons of technological characteristics, intended use, and performance characteristics. The acceptance criteria aren't explicitly numerical thresholds as one might see for a diagnostic AI.
Here's a table based on the provided "Substantial Equivalence Summary" (Table 1):
| Characteristic | Acceptance Criteria (Implied by Predicate Devices) | Reported Device Performance (Atlantis™ Abutment & Crown Abutment in Zirconia) |
|---|---|---|
| Material | - Titanium Alloy (Keystone Genesis Implant System K#101545) | - Titanium Alloy |
| - Biocompatible ceramic material (Astra Tech's Atlantis™ Crown Abutment in Zirconia K#110356) | - Biocompatible ceramic material (Zirconia: yttria-stabilized tetragonal zirconia polycrystals (Y-TZP) meeting ISO Standards 6972 & 13356)) | |
| Performance Characteristics | Allows prosthesis to be cemented or screw retained to abutment. Abutment screw secures abutment to implant. (Both predicates) | Allows the prosthesis to be cemented or screw retained to abutment. Abutment screw is intended to secure the abutment to the endosseous implant. (For Zirconia Crown Abutment, prosthesis is screw retained and abutment screw secures the crown abutment to the endosseous implant.) |
| Intended Use | - Support prosthetic device in partially/completely edentulous patients. | - Titanium & zirconia abutments: Support prosthetic device in partially/completely edentulous patients (single/multiple tooth prosthesis, mandible/maxilla). |
| - Support single or multiple tooth prosthesis, in mandible or maxilla. | - Zirconia Crown Abutment: Function as a substructure and final restoration in partially/completely edentulous patients (single/multiple tooth prosthesis, mandible/maxilla). Prosthesis is screw retained; abutment screw secures crown abutment. | |
| - For crown abutments: Function as substructure and final restoration, screw retained. | ||
| Mechanical Stability | Implied equivalent to predicate devices through static and fatigue testing. | "Test results demonstrated that the Atlantis Abutments are compatible with the Keystone Genesis implants and the implant system supported appropriate static and fatigue test loads demonstrating that the implant system performs as intended." |
2. Sample size used for the test set and the data provenance
- Sample Size: The document mentions "worst case scenario" implant assemblies were tested, but it does not specify the numerical sample size used for the static and fatigue compression testing.
- Data Provenance: The testing was conducted as part of the premarket submission by Astra Tech Inc. It is internal testing to demonstrate the device's compatibility and performance. The document does not specify the country of origin of the data further than implying it's internal to the manufacturer's R&D process. It is prospective data generated specifically for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable and not provided in the context of this 510(k) submission. For medical devices like dental abutments, "ground truth" is typically established through direct physical and mechanical testing (e.g., material properties, static and fatigue strength) against engineering standards and comparison to predicate devices, rather than expert consensus on observational data.
4. Adjudication method for the test set
This information is not applicable and not provided. Adjudication methods like 2+1 or 3+1 are used in studies where human readers evaluate cases (e.g., medical images) and their interpretations need to be reconciled. This submission focuses on physical performance testing.
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
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic or assistive devices where human performance with and without AI assistance is being compared. The device in question is a physical dental abutment, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone performance evaluation of an algorithm was not done. This device is a physical product, not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the performance of the Atlantis™ Abutment and Atlantis™ Crown Abutment is established through physical and mechanical testing (static and fatigue compression testing) designed to simulate the in-vivo environment and demonstrate that the device performs as intended and is comparable to previously cleared predicate devices. The "truth" is based on meeting engineering specifications and demonstrating mechanical integrity under specified loads.
8. The sample size for the training set
This information is not applicable and not provided. There is no "training set" in the context of developing and validating a physical dental abutment. Training sets are used for machine learning algorithms.
9. How the ground truth for the training set was established
This information is not applicable and not provided for the same reason as in point 8.
§ 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.)