(114 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 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 abutments are compatible with the Keystone 3.5mm, 4.1mm and 5.0mm Keystone Implants. The zirconia abutments are compatible with the Keystone 3.5mm, 4.1mm and 5.0mm Keystone 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 only.
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 or screw retained restorations. The Atlantis™ Abutment for Keystone Implant and abutment screw are made of Titanium grade Ti-6A1-4V ELI (meets ASTM Standard F-136) for the 3.5mm, 4.0mm, 4.1mm and 5.0mm sizes. In addition, the Atlantis™ Abutment for Keystone Implant for the 3.5mm, 4.1mm and 5.0mm sizes are also made of biocompatible material, yttria-stabilized 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.
The provided text describes a 510(k) premarket notification for a medical device, specifically the Atlantis™ Abutment for Keystone Implant. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than conducting a full clinical study with specific acceptance criteria and detailed performance metrics as one might find for a novel device requiring a PMA.
Therefore, the information typically requested in your prompt regarding acceptance criteria and a study proving those criteria are met is not fully applicable in the context of this 510(k) summary. The testing performed is non-clinical and aimed at demonstrating equivalence in performance characteristics to existing, legally marketed devices.
Here's an analysis based on the available information:
1. Table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Inferred from Equivalence) | Reported Device Performance |
|---|---|
| Material Equivalence: Titanium Alloy and Biocompatible Ceramic material (Y-TZP) | Device uses Titanium grade Ti-6A1-4V ELI (meets ASTM Standard F-136) and yttria-stabilized tetragonal zirconia polycrystals (Y-TZP) (meets ISO Standards 6972 & 13356). |
| Performance Characteristics Equivalence: Allows prosthesis to be cemented or screw-retained to abutment; abutment screw secures abutment to endosseous implant. | Device allows prosthesis to be cemented or screw-retained to abutment; abutment screw secures abutment to endosseous implant. |
| Intended Use Equivalence: Supports prosthetic device in partially/completely edentulous patients; for single/multiple tooth prosthesis in mandible/maxilla; compatible with specific implant systems (Keystone 3.5mm, 4.0mm, 4.1mm, 5.0mm); early load situations dependent on implant system/protocol; highly angled abutments on small diameter implants for anterior region only. | Device's intended use matches the predicate device's intended use across all specified conditions. |
| Mechanical Integrity/Durability: Ability to support appropriate static and fatigue test loads ("worst case scenario" implant assemblies). | Static and fatigue compression testing demonstrated that the implant system performs as intended, supporting appropriate static and fatigue test loads. |
Explanation: For a 510(k), "acceptance criteria" are implied by demonstrating that the new device's technological characteristics, performance, and intended use are sufficiently similar to a predicate device. The "reported device performance" is the result of non-clinical testing verifying these similarities. There aren't explicit numerical thresholds like accuracy or sensitivity for this type of device and submission.
2. Sample size used for the test set and the data provenance:
- Sample size: Not explicitly stated. The document mentions "worst case scenario" implant assemblies were used for static and fatigue compression testing. The exact number of test samples is not provided.
- Data provenance: The testing was "non-clinical testing" conducted by the manufacturer, Astra Tech Inc. There is no mention of country of origin of the data or whether it was retrospective or prospective, as a clinical study was not performed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This was a non-clinical, engineering-based performance study, not a clinical study involving ground truth established by expert clinicians.
4. Adjudication method for the test set:
- Not applicable, as this was not a clinical study requiring expert adjudication of results.
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. This device is an endosseous dental implant abutment, a mechanical component, not an AI-driven diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used:
- For the non-clinical testing, the "ground truth" was adherence to established mechanical testing standards (e.g., ASTM, ISO referenced for materials) and the performance characteristics of the predicate device. The performance was assessed against engineering principles and the functional requirements of an abutment, rather than clinical outcomes or pathology.
8. The sample size for the training set:
- Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable.
Summary of the Study Proving Device Meets Acceptance Criteria:
The study described is a "Summary of Non-clinical Testing." This testing involved:
- Study Type: Static and fatigue compression testing.
- Purpose: To demonstrate that the Atlantis Abutments are compatible with Keystone implants and perform as intended under mechanical stress.
- Methodology: Testing was conducted on "worst case scenario" implant assemblies using Atlantis angled titanium and zirconia abutments with the Keystone implant.
- Results: The test results demonstrated that the implant system supported appropriate static and fatigue test loads, indicating that the device performs as intended and is substantially equivalent in performance characteristics to the predicate device.
In the context of a 510(k) for a device like a dental abutment, the "acceptance criteria" are predominantly met through demonstrated material equivalence, functional equivalence, and successful non-clinical mechanical testing that ensures the device is as safe and effective as the predicate device. Clinical trials with human subjects, expert review, or AI performance metrics are generally not required for this type of submission.
§ 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.)