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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 cement 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 Dentsply 3.5mm, 4.5mm, 5.5mm and 7.0mm Ankylos 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 (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 or screw retained restorations. The Atlantis™ Abutment for Dentsply Ankylos Implant and abutment screw are made from Titanium grade Ti-6A 1-4V ELI (meets ASTM Standard F-136) for the 3.5mm, 4.5mm, 5.5mm, and 7.0mm sizes. The titanium 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 Atlantis™ Abutment for Dentsply Ankylos Implant:

This document is a 510(k) Summary, which typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance studies against specific acceptance criteria for a new device's efficacy. In this case, the device is an implant abutment, which is a component of a dental implant system. The "performance" discussed primarily relates to its compatibility and functional equivalence to existing, legally marketed components.

Based on the provided text, a formal study with quantitative acceptance criteria as one might expect for a diagnostic AI device is not presented. Instead, the submission relies on demonstrating substantial equivalence to predicate devices.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) submission for substantial equivalence for a physical medical device (dental abutment), the "acceptance criteria" are not framed in terms of metrics like sensitivity, specificity, or accuracy that would be typical for an AI/diagnostic study. Instead, the acceptance criteria are met by demonstrating the device is:

• Substantially equivalent in intended use, material, design, and performance to the predicate devices.
• Able to perform the same functions as the predicate devices.
• Made of the same material as the predicate device.

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

No specific "test set" in the context of an AI study is mentioned. The submission relies on a comparison of characteristics and intended use to existing, legally marketed predicate devices (Dentsply Ankylos C/X Dental Implant System K083805 and Astra Tech Inc. Atlantis™ Abutment K093780). There is no mention of data provenance (e.g., country of origin, retrospective/prospective) for a performance study.

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

Not applicable. The document describes a physical medical device (dental abutment), not an AI or diagnostic device that would require expert-established ground truth for a test set.

4. Adjudication Method for the Test Set

Not applicable. There is no human-reviewed test set or adjudication method described.

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 is a filing for a physical medical device, not an AI or diagnostic software subject to MRMC studies.

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

Not applicable. This is a filing for a physical medical device, not an AI algorithm.

7. The Type of Ground Truth Used

Not applicable. The "ground truth" for a physical device like a dental abutment would be its physical properties, material composition, manufacturing tolerances, and functional performance (e.g., torque strength, fatigue resistance), typically evaluated through engineering tests, not a "ground truth" as understood in AI/diagnostic studies. The document mentions ASTM Standard F-136 for material, which provides a standard specification for titanium alloy for surgical implants, serving as a form of "ground truth" for material properties.

8. The Sample Size for the Training Set

Not applicable. There is no training set mentioned, as this is not an AI or machine learning device.

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

Not applicable. There is no training set or associated ground truth establishment process described.

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