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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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