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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 mandible or maxilla. The prosthesis can be cemented or screw retained to the abutment screw is intended to secure the ATLANTIS® Abutment to the endosseous implant.

The ATLANTIS® Crown Abutment is intended for use with an endosseous implant to function as a substructure that also serves as the final restoration, in a partially or completely edentulous patient. The abutment screw is intended to secure the ATLANTIS® Crown Abutment to the endosseous implant.

The ATLANTIS® Conus Abutment is intended for use with an endosseous implant to support a prosthetic device in partially or completely edentulous patients. It is intended for use to support a removable multiple tooth prosthesis, in the mandible or maxilla. The prosthesis is attachment. The abutment. The abutment. The abutment screw is intended to secure the ATLANTIS® Conus Abutment to the endosseous implant.

ATLANTIS® Abutment for MIS implant is compatible with MIS implant System. MIS short implants (6mm) are to be used only with straight abutments.

ATLANTIS® products are compatible with the implants shown in the table below.

The proposed ATLANTIS® Abutment for MIS Implant is an endosseous dental implant abutment. The subject device is provided for implant diameter (Ø3.3, 3.75, 4.2, 5.0 and 6.0 mm) and three designs: ATLANTIS® Abutment for MIS Implant, ATLANTIS® Crown Abutment for MIS Implant and ATLANTIS® Conus Abutment for MIS Implant, see table 5-1. All are patient-specific abutments fabricated using CAD/CAM technology at Dentsply Implant manufacturing sites. Each abutment is designed according to prescription instructions from the clinician to support a screw-retained, cement-retained or friction fit prosthesis.

The coronal portion of the ATLANTIS® Abutment can be fabricated as a conventional abutment for prosthesis attachment (ATLANTIS® Abutment or ATLANTIS® Conus Abutment) or fabricated as a single tooth final restoration onto which porcelain is added (ATLANTIS® Crown Abutment). The ATLANTIS® abutment interface is compatible with the MIS implants from the MIS Implant System (K040807) and MIS implants from MIS Short Implants (K103089).

The MIS M4 & SEVEN implant interface has an internal hex connection and provided for implant platform diameter Narrow (3.30 mm), Standard (3.75 and 4.20 mm) and Wide (5.0 and 6.0 mm). The abutment height ranges from 3.3 to 13 mm, the maximum abutment height is 15 mm above implant interface and the minimum abutment height is 4 mm above the trans-mucosal collar. The abutment is provided straight and up to 30° of angulation.

The provided text is a 510(k) Pre-Market Notification for the ATLANTIS® Abutment for MIS Implant. It does not describe an AI/ML powered medical device, but rather a dental implant abutment which is a physical device. Therefore, the questions related to AI/ML device acceptance criteria and study design are not applicable.

However, I can provide the acceptance criteria and the study that proves the physical device meets its acceptance criteria based on the information provided in the document.

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

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

The document does not explicitly state the sample sizes used for the mechanical testing or geometric analyses. It also does not specify the country of origin or whether the data was retrospective or prospective. These details are typically found in the full test reports referenced in the 510(k) submission, not in the summary document.

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. This is a physical device, not an AI/ML device that requires expert ground truth for image interpretation or diagnosis. The "ground truth" for this device would be established by engineering specifications, materials science standards, and established regulatory test methodologies.

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

Not applicable. This is a physical device, not an AI/ML device that requires expert adjudication for diagnostic outputs. The performance is assessed through standardized engineering tests.

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 physical device, 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 a physical device, not an AI/ML device.

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

The "ground truth" for this medical device would be defined by engineering standards, material properties, and regulatory performance requirements. For example:

• Mechanical Testing: Ground truth is defined by the requirements of ISO 14801, which sets pass/fail criteria for fatigue strength, and by the established strength and durability of the predicate device.
• Dimensional Compatibility: Ground truth is defined by the precise geometric specifications and tolerances of the MIS implant interface, ensuring a proper fit.
• Sterilization: Ground truth is defined by the validation criteria outlined in ISO 17665-1 and ISO 20857, ensuring a sterile product.
• Biocompatibility: Ground truth is established by the accepted biocompatibility of the identical materials used in the predicate device.

8. The sample size for the training set

Not applicable. This is a physical device, not an AI/ML device that requires a training set.

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

Not applicable. This is a physical device, not an AI/ML device.

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