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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 for Astra Tech Osseospeed Implant is compatible with the Astra Tech Osseospeed Plus 3.6mm and 4.2mm 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 subject abutments are indicated for cemented or screw retained restorations. The Atlantis™ Abutment in Zirconia for Astra Tech Osseospeed Plus Implant for the Astra Tech Osseospeed Plus 3.6mm and 4.2mm Implants is made of biocompatible material, yttria-stabilized tetragonal for the zirconia polycrystals (Y-TZP) ( meets ISO Standards 6972 & 13356). Zirconia may have variation in shade. The abutment screw 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.

This is not an AI/ML device and therefore no AI/ML specific information can be extracted.

The document describes the Atlantis™ Abutment in Zirconia for Astra Tech Osseospeed Plus Implant.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:

The document states that "Static and fatigue compression testing was conducted on 'worst case scenario' implant assemblies." However, it does not specify the exact sample size (number of assemblies tested) or the data provenance (e.g., country of origin, retrospective or prospective).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts:

This information is not applicable as the study described is a non-clinical, mechanical testing study, not a study evaluating human interpretation or diagnosis. Therefore, no experts were needed to establish ground truth in this context.

4. Adjudication Method for the Test Set:

This information is not applicable for the same reason as point 3.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done:

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. The study was non-clinical mechanical testing of an implant abutment.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

This information is not applicable as the device is a physical medical device (dental abutment), not an algorithm or AI system.

7. The Type of Ground Truth Used:

The ground truth for the non-clinical testing was based on engineering standards and expected mechanical performance limits for dental implant systems, as detailed in ISO Standards 6972 & 13356 and ASTM Standard F-136. The "appropriate static and fatigue test loads" represent the ground truth for mechanical integrity.

8. The Sample Size for the Training Set:

This information is not applicable as the device is a physical medical device and does not involve AI/ML a training set.

9. How the Ground Truth for the Training Set Was Established:

This information is not applicable for the same reason as point 8.

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