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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 3.0mm, 3.8mm, 4.5mm and 5.5mm XiVE® S Plus Implants.

The titanium and zirconia abutments are compatible with the Dentsply 3.4mm, 3.8mm, 4.5mm, 5.5mm and 6.5mm Frialit® Plus Implants.

The zirconia abutments are compatible with Dentsply 3.4mm, 4.5mm and 5.5mm XiVE® S Plus 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 Implant and abutment screw are made from Titanium grade Ti-6A1-4V ELI (meets ASTM Standard F-136) for the 3.0mm, 3.4mm, 3.8mm, 4.5mm, 5.5mm and 6.5mm sizes. In addition, the Atlantis™ Abutment for Dentsply Implant for the 3.4mm, 3.8mm, 5.5mm and 6.5mm sizes, also are made of the biocompatible material, yttria-stabilized tetragonal zirconia polycrystals (Y -TZP) (meets ISO Standards 6072 & 13356). Zirconia may have a variation in shade. The titanium and the zirconium abutments are placed over the implant shoulder and are mounted into the implant with a titanium screw.

The provided text is a 510(k) summary for the Atlantis™ Abutment for Dentsply Implant. It describes the device, its intended use, and claims substantial equivalence to predicate devices. However, it does not contain information about acceptance criteria or a study proving the device meets those criteria, as typically understood in the context of performance metrics like sensitivity, specificity, accuracy, or reader studies for AI/medical imaging devices.

The document primarily focuses on establishing substantial equivalence based on material, design, and intended use to previously cleared devices. It does not present a clinical performance study with defined acceptance criteria and reported device performance in the way requested.

Therefore, many of the requested fields cannot be populated from the provided text.

Here's a breakdown based on what can be inferred or determined to be absent from the document:

1. A table of acceptance criteria and the reported device performance

• Not applicable / Not provided. The document establishes substantial equivalence based on materials, design, and intended use, not on specific performance metrics with acceptance criteria like sensitivity, specificity, etc.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not applicable / Not provided. No specific test set data is mentioned for performance evaluation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable / Not provided. No ground truth establishment is described for a performance test.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable / Not provided. No adjudication method is 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 / Not provided. This device is a dental abutment, not an AI or imaging device that would typically undergo MRMC studies.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable / Not provided. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not applicable / Not provided. No performance-related ground truth is discussed.

8. The sample size for the training set

• Not applicable / Not provided. This is not an AI/machine learning device that uses training sets.

9. How the ground truth for the training set was established

• Not applicable / Not provided. This is not an AI/machine learning device.

Summary of what the document does provide:

The document focuses on demonstrating substantial equivalence to predicate devices by comparing:

• Intended Use: The Atlantis™ Abutment is intended for use with an endosseous implant to support a prosthetic device in partially or completely edentulous patients, supporting single and multiple tooth prostheses in the mandible or maxilla, with cement or screw-retained options. This aligns with the predicate devices.
• Materials: The abutments are made from Titanium grade Ti-6A1-4V ELI (ASTM Standard F-136) and yttria-stabilized tetragonal zirconia polycrystals (Y-TZP) (ISO Standards 6072 & 13356). These materials are commonly used in dental implants and are present in equivalent forms in the predicate devices.
• Design: The device functions as an abutment placed into a dental implant to support a prosthetic restoration. Compatibility with specific Dentsply implant systems is detailed. The design is considered substantially equivalent to the predicate devices.
• Performance (as implied by equivalence studies, not specific metrics): The document implies that because the materials, design, and intended use are substantially equivalent to legally marketed predicate devices, its performance is also considered equivalent. This typically involves non-clinical bench testing (e.g., mechanical strength, fatigue, biocompatibility) rather than clinical performance metrics in the context of this type of device. While the 510(k) summary doesn't detail these tests, such data would typically be part of the full 510(k) submission to demonstrate the performance equivalence to the predicate.

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