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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-retained by friction fit to the abutment screw is intended to secure the ATLANTIS® Conus Abutment to the endosseous implant.

The ATLANTIS® Healing Abutment can be used with an endosseous implant for temporary use during soft tissue healing after one-stage or two-stage surgeries. The abutment screw is intended to secure the ATLANTIS® Healing Abutment to the endosseous implant.

ATLANTIS® Abutment is compatible with MIS Conical Connection implant from MIS Implant System.

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

Implant Diameter V3: Ø3.30 mm C1: Ø3.30 mm C1: Ø3.75,4.2 mm, V3: Ø3.90,4.3,5.0 mm C1: Ø5.0 mm

The proposed ATLANTIS® Abutments for MIS Conical Connection Implant are endosseous dental implant abutments.

The proposed devices are compatible with:

• MIS V3 conical connection narrow and standard dental implant diameters Ø3.3, 3.9, 4.3 and a. 5.0 mm (K163349)
• b. MIS C1 narrow, standard and wide platform conical connection implant diameters Ø3.3, 3.75, 4.2, and 5.0 (K172505, K112162)

Refer to Table 5.1 for the implants the proposed ATLANTIS® Abutments for MIS Conical Connection Implant are compatible with.

| Table 5.1 Implant systems which proposed ATLANTIS® Abutments for MIS Conical Connection

The abutments are available in four (4) designs:

• ATLANTIS® Abutment for MIS Conical Connection Implant, a.
• ATLANTIS® Crown Abutment for MIS Conical Connection Implant, b.
• ATLANTIS® Conus Abutment (Custom or Overdenture) for MIS Conical Connection C. Implant
• d. ATLANTIS® Healing Abutment for MIS Conical Connection Implant

The materials composition of the proposed devices are described below in Table 5.2.

The maximum abutment height is 15 mm above implant interface and the minimum abutment height is 4 mm above the trans-mucosal collar. The abutments are provided straight and up to 30° of angulation.

All proposed abutments are patient-specific abutments fabricated using CAD/CAM technology by Dentsply Sirona Implants. 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® Abutments for MIS Conical Connection Implant can be fabricated as a conventional abutment for prosthesis attachment (ATLANTIS® Abutment for MIS Conical Connection Implant or ATLANTIS® Conus Abutment for MIS Conical Connection Implant), fabricated as a single tooth final restoration onto which porcelain is added ATLANTIS® Crown Abutment for MIS Conical Connection Implant) or fabricated with a short core for soft tissue healing (ATLANTIS® Healing Abutment).

This document describes the Dentsply Sirona ATLANTIS® Abutment for MIS Conical Connection Implants and its substantial equivalence to predicate devices, based on non-clinical performance data. There is no information provided about an AI/ML device in this document, so the questions regarding AI/ML device performance are not applicable.

Here's an analysis based on the provided text, focusing on the mechanical and material aspects of the device, and addressing the questions where applicable:

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

The document does not explicitly state "acceptance criteria" in a quantitative manner with reported performance metrics to directly compare. Instead, it relies on demonstrating substantial equivalence to predicate devices through various tests and comparisons. The performance is assessed against established standards and predicate device characteristics.

However, based on the non-clinical performance data section, we can infer some criteria and the types of performance reported:

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 size for the "test set" in terms of number of abutments or implants used, nor does it specify the country of origin or whether the data was retrospective or prospective for the non-clinical tests. It refers to "fatigue testing" and "geometric compatibility analysis," which are bench tests.

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)

This question is not applicable as the document describes a dental abutment, not an AI/ML device requiring expert ground truth for interpretation of images or other data. The "ground truth" for this device would be its physical and mechanical properties, assessed through engineering and materials testing, not expert review.

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

Not applicable. Adjudication methods like 2+1 or 3+1 typically refer to expert review processes for clinical or image interpretation studies, which are not relevant to the non-clinical bench testing described for this dental abutment.

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 document is about a dental implant abutment, not an AI-assisted diagnostic or therapeutic device. There are no human readers or AI involved in its function.

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 (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this device's performance relies on established engineering standards and material properties, and comparison to legally marketed predicate devices' performance.

• Fatigue Resistance: Ground truth would be defined by the specified load cycles and failure criteria outlined in ISO 14801.
• Geometric Compatibility: Ground truth is the precise dimensional specifications of the OEM implant bodies, OEM abutments, and OEM screws.
• Sterilization: Ground truth is the successful validation according to ISO 17665-1.
• Biocompatibility: Ground truth is the conformity of materials to ASTM F136 and the established biocompatibility of the predicate device (K172225) using identical materials and processes.
• Design Specifications: Ground truth lies in the adherence to predefined maximums and minimums for angulation, height, and width.

8. The sample size for the training set

Not applicable as this is not an AI/ML device.

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

Not applicable as this is not an AI/ML device.

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The ATLANTIS® Conus Structure is indicated for attachment to ATLANTIS® Conus abutment, Overdenture (OD) via prefabricated SynCone 5° Taper caps (Degulor®) in the treatment of partially or totally edentulous jaws for the purpose of restoring chewing function.

The ATLANTIS® Conus Structure is intended for conical attachment to a minimum of four (4) ATLANTIS® Conus abutments, Overdenture (OD). The ATLANTIS® Conus Structure is only intended for acrylic or composite veneering.

The proposed ATLANTIS® Conus structure is a patient-specific endosseous dental implant support structure that is indicated for attachment to dental abutments in the treatment of partially or totally edentulous jaws for the purpose of restoring chewing function.

The design of the proposed device is derived from patient dental models and completed by Dentsply Sirona technicians using computer-assisted design (CAD) according to the clinician's prescription. The final CAD design of the ATLANTIS® Conus Structure is fabricated using additive manufacturing to produce a customized, patient-specific device.

The proposed ATLANTIS® Conus Structure is available in the following design types:

1. ATLANTIS® Conus Bridge Intended for direct veneering using dental resin composites resulting in a removable friction-retained prosthesis. The bridge provides a full anatomical base for composite layering techniques.
2. ATLANTIS® Conus Hybrid Intended as a removable friction-retained denture framework. The hybrid variant provides a surface with retention elements that can be finished with resin-based denture prosthesis.
3. ATLANTIS® Conus Base Intended as a removable friction-retained denture framework for finishing with the resin-based denture prosthesis.

The provided text describes the ATLANTIS® Conus Structure, a dental device, and its substantial equivalence to predicate devices, rather than a study proving the device meets specific acceptance criteria in the context of diagnostic accuracy or clinical effectiveness with human readers or ground truth established by experts.

The document is a 510(k) summary for a medical device, which focuses on demonstrating substantial equivalence to a legally marketed predicate device, primarily through non-clinical performance data and technological characteristics comparison. It does not contain information about a clinical study with acceptance criteria for diagnostic performance, human reader improvement, or ground truth established by experts.

However, I can extract the acceptance criteria and performance data for the non-clinical performance tests described:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

The document does not specify the sample sizes for the non-clinical performance tests (dynamic fatigue, bond strength, dimensional verification). The data provenance is internal testing performed by Dentsply Sirona. These are prospective tests designed to evaluate the physical properties of the device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This device is not a diagnostic tool requiring expert interpretation or ground truth establishment in a clinical sense. The "ground truth" here pertains to engineering specifications and performance standards outlined in ISO 14801 and internal Dentsply Sirona testing protocols.

4. Adjudication method for the test set

Not applicable. The tests are mechanical and dimensional, not requiring expert adjudication of results. The results are typically compared against pre-defined engineering specifications.

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 dental implant component, not an AI-assisted diagnostic device.

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

Not applicable. This is a physical dental implant component, not an algorithm.

7. The type of ground truth used

For the non-clinical performance tests, the "ground truth" refers to established engineering standards (e.g., ISO 14801) and internal design specifications for mechanical strength, bond strength, and dimensional accuracy.

8. The sample size for the training set

Not applicable. The device is a physical product, not an AI model requiring a training set. The design and manufacturing processes are iterative but do not involve "training data" in the AI sense.

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

Not applicable, as there is no "training set" for this physical device. The design and manufacturing parameters are established through engineering principles, material science, and prior regulatory clearances of similar devices.

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