(106 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 Atlantis Abutment in Zirconia is compatible with the Astra Tech Osseospeed TX Profile 4.5, 5.0 and 5.0 S 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 angulated abutments on small 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 subject abutments are indicated for cemented or screw retained restorations. The Atlantis™ Abutment in Zirconia for Osseospeed TX Profile Implant for the Astra Tech Osseospeed Profile 4.5, 5.0 and 5.0 S Implants is made of biocompatible material, yttria-stabilized tetragonal for the zirconia polycrystals (Y-TZP) ( meets SO Standards 6972 & 1356). Zircomia may have variation in shade. The abutment serew is made of Titanium grade Ti-6A1-4V ELI (meets ASTM Standard F-136). The zirconia abutments are placed over the implant shoulder and are mounted into the implant with a titanium screw.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Astra Tech Atlantis™ Abutment in Zirconia for Osseospeed TX Profile Implant:
This summary does not contain the level of detail requested for many of your points, specifically for a typical AI/ML medical device submission. This document is a 510(k) summary for a dental abutment, which is a traditionally regulated medical device, not an AI/ML device. Therefore, many of the questions regarding AI/ML study design (e.g., sample sizes for test/training sets, data provenance, expert ground truth, MRMC studies) are not applicable or the information is not present in this type of submission.
The primary method of demonstrating substantial equivalence for this device is based on comparison to predicate devices and non-clinical engineering testing, rather than a clinical study evaluating diagnostic or prognostic performance of an algorithm.
Acceptance Criteria and Reported Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a non-AI/ML device, there are no "acceptance criteria" in the sense of performance metrics like sensitivity, specificity, or AUC against a ground truth. Instead, the acceptance is based on meeting engineering performance standards and demonstrating substantial equivalence to predicate devices. The study performed was focused on mechanical integrity.
| Acceptance Criteria (Implied from testing described) | Reported Device Performance (Summary of Study Results) |
|---|---|
| Withstand static compression loads | "the implant system supported appropriate static... loads" |
| Withstand fatigue compression loads | "...and fatigue test loads" |
| Compatibility with Astra Tech Osseospeed TX Profile implants | "Atlantis Abutments are compatible with the Astra Tech Osseospeed TX Profile implants" |
| Perform as intended (mechanical integrity) | "demonstrating that the implant system performs as intended." |
Study Details (Based on available information)
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified. The document states "Static and fatigue compression testing was conducted on 'worst case scenario' implant systems using Atlantis angled zirconia abutments with the Astra Tech Osseospeed TX Profile implant." This implies a limited number of physical samples were tested, not a large patient data set.
- Data Provenance: Not applicable in the context of patient data. This was laboratory-based mechanical testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth for mechanical testing is based on engineering specifications and physical measurements, not expert human interpretation.
4. Adjudication method for the test set:
- Not applicable. This was mechanical testing, not a study requiring adjudication of expert interpretations.
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, an MRMC study was not done. This is not an AI/ML device.
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 mechanical testing, the "ground truth" (or reference standard) would be the established engineering standards and specifications for static and fatigue loads on dental implant abutments.
8. The sample size for the training set:
- Not applicable. This device does not involve an AI/ML algorithm or a "training set" in that context.
9. How the ground truth for the training set was established:
- Not applicable.
Summary of the "Study" and Conclusions from the Document:
The core of the "study" described in this 510(k) summary is non-clinical bench testing.
- Study Design: Static and fatigue compression testing was performed on "worst case scenario" configurations of the Atlantis Abutment in Zirconia integrated with the Astra Tech Osseospeed TX Profile implant system.
- Purpose: To demonstrate the mechanical compatibility and integrity of the new abutment with the specified implant system, and ultimately to support substantial equivalence to predicate devices.
- Results: The tests showed that the implant system (with the new abutments) "supported appropriate static and fatigue test loads demonstrating that the implant system performs as intended."
- Conclusion for Substantial Equivalence: Based on the similarities in material, design principles, performance characteristics, and the successful non-clinical testing, the device was deemed substantially equivalent to the predicate devices (Astra Tech's Osseospeed TX Profile System K080156 and the Atlantis Abutment in Zirconia for Astra Implant K071946).
§ 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.)