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The Atlantis Abutment and Atlantis Abutment Milling are 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 Atlantis 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 Atlantis 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 an attachment- retained by friction fit to the abutment. The Atlantis Abutment screw is intended to secure the Atlantis Conus Abutment to the endosseous implant.
The Atlantis Healing Abutment is intended for use with an endosseous implant for temporary use during soft tissue healing after one-stage or two-stage surgeries. The Atlantis Abutment screw is intended to secure the Atlantis Healing Abutment to the endosseous implant.

Atlantis® Abutment in Titanium refers to the following abutments that are the subject of this 510(k):

• Atlantis® Abutment,
• Atlantis® Crown Abutment,
• Atlantis® Conus Abutment, and
• Atlantis® Healing Abutment.

The Atlantis® Abutments in Titanium are patient-specific dental abutments that are intended for attachment to dental implants in the treatment of partially or totally edentulous jaws for the purpose of restoring chewing function. The design of the Atlantis® Abutments in Titanium is derived from patient dental models and is completed by Dentsply Sirona using computer-assisted design (CAD) technology according to the clinician's prescription. The final CAD design of the Atlantis® Abutment in Titanium is fabricated using computer-assisted manufacturing (CAM) to produce a customized, patient-specific device. Design and fabrication of the Atlantis® Abutment in Titanium is completed in internal Dentsply Sirona manufacturing facilities.

Alternatively, the CAD design, according to the clinician's prescription, can be performed by a laboratory or clinician in an FDA cleared abutment design software (3Shape Abutment Designer Software, K151455) within the design envelope of the Atlantis® Abutments which is codified in the validated and locked design library of the cleared software. Fabrication of the Atlantis® Abutment is then completed in internal Dentsply Sirona manufacturing facilities.

The Atlantis® Abutment in Titanium serves as a connection of the prosthetic construction and the endosseous implant. The lower part of the abutment is designed to fit with the specific implant geometry it is compatible, and the upper part design is according to the patient's specific anatomy. The Atlantis® Abutment in Titanium, including the Conus abutments and Healing abutments, are available in Titanium or Gold-shaded Titanium (titanium nitride layer applied using PVD (Physical Vapor Deposition)). The Crown Abutment is only available in Titanium.

The Atlantis® Abutment design envelope became the basis for the other more specific designs that make up the Atlantis® Abutments in Titanium. The Atlantis® Abutment is intended for use with an endosseous implant and for single tooth restoration.

The Atlantis® Crown Abutment in Titanium incorporates a design that is a combination of an abutment and an anatomically accurate crown to constitute the final finished device. It functions as a substructure that also serves as the final abutment, in a partially or completely edentulous patient.

The Atlantis® Conus abutment supports a removable prosthesis (bridges and overdentures) which is retained by friction fit to the abutment. The abutment connects to the prosthesis via caps embedded in the prosthesis.

The Atlantis® Healing Abutment is used with the compatible implants for temporary use during soft tissue healing after one-stage and two-stage surgeries. It is designed based on the planned final Atlantis® Abutment or Atlantis® Crown Abutment, using the same emergence profile as those abutments to achieve an aesthetic outcome during the soft tissue healing phase.

Unless otherwise noted in this summary, the design envelope has remained unchanged from the previously cleared systems. Parameters such as gingival height and abutment diameter are dependent on the different implant system compatibilities.

The provided document is an FDA 510(k) clearance letter for Atlantis® Abutments in Titanium. This document indicates that the device has received clearance and is considered substantially equivalent to previously marketed devices. However, it is not a clinical study report and therefore does not contain the detailed information typically found in a study that proves a device meets acceptance criteria derived from a clinical trial.

Specifically, the document primarily focuses on non-clinical testing (e.g., MRI compatibility, biocompatibility, reprocessing, and CAD/CAM software validation) to support a labeling change and the substantial equivalence to predicate devices. It explicitly states:

• "8. Clinical Tests Summary and Conclusion: Not applicable. There are no clinical tests submitted, referenced, or relied on in the 510(k) for a determination of substantial equivalence."

Therefore, I cannot extract the requested information (Acceptance Criteria Table, Sample Size, Data Provenance, Ground Truth Experts, Adjudication Method, MRMC Study, Standalone Performance, Ground Truth Type, Training Set Size, Training Set Ground Truth Establishment) from this document as it pertains to a clinical study proving device performance against acceptance criteria.

The information from the document that is relevant to non-clinical testing and device characteristics is provided below.

Non-Clinical Testing and Device Characteristics from the 510(k) Clearance Letter

While a clinical study proving performance against acceptance criteria is not presented, the document does describe the non-clinical tests performed to support the device's safety and effectiveness and its substantial equivalence to predicate devices.

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

Since this is a 510(k) clearance notice based on substantial equivalence and non-clinical testing, there isn't a direct "acceptance criteria table" in the traditional sense of a clinical trial's performance endpoints. However, the document outlines standards and guidance documents used as criteria for the non-clinical tests, and the stated conclusion is that the device meets these requirements.

• ASTM F2213-17: Measurement of magnetically induced torque
• ASTM F2119-07 (2013): Evaluation of MR image artifacts from passive implants
• ASTM F2503-20: Marking medical devices for MR safety
• FDA guidance: "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment" (October 10, 2023) | MR Conditional. Testing included in reference device (K221094) supports labeling update.
  The proposed Atlantis® Abutments in Titanium meet the requirements. |
  | Biocompatibility | - ISO 10993-1:2018: Biological evaluation of medical devices – Part 1
• ISO 10993-5:2009: Cytotoxicity testing | Biocompatibility assessment was performed and no new questions regarding biocompatibility are raised. Cytotoxicity testing was performed. |
  | Reprocessing (Sterilization Drying Time) | - ANSI/AAMI/ISO 17665-1:2006/(R)2013, Annex D
• ANSI/AAMI/ISO 14937:2009/(R)2013, Annex D (Approach 3)
• AAMI TIR12:2020
• ANSI/AAMI/ISO TIR17665-2:2009
• FDA guidance: "Reprocessing Medical Device in Health Care Settings: Validation Methods and Labeling" | Reprocessing testing was performed to validate the proposed drying time for steam sterilization. The sterilization drying time validation followed the FDA guidance and relevant standards. |
  | CAD/CAM Software Validation & Verification (Atlantis® Abutment Milling) | To ensure that the same design limitations/constraints present in the 3Shape Atlantis® Abutment library match those in the internal CAD system, and that the design parameters cannot be exceeded. | Software validation was performed and confirmed that the additional option of using the 3Shape design module for design of Atlantis® Abutments does not raise new questions of safety and performance as it was confirmed that the locked design library has the same design limits as the internal VAD software. |
  | Mechanical Performance (Fatigue Testing) | - ISO 14801:2016: Implants – Dynamic loading test for endosseous dental implants
• FDA Guidance: Root-form Endosseous Dental Implants and Endosseous Dental Abutments – Class II Special Controls Guidance Document. | The internally documented and proposed modifications did not affect the performance of the devices and no new fatigue testing was needed. The abutments continue to meet the requirements. |

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

• Sample Size for Non-Clinical Tests: Not explicitly stated as numerical sample sizes (e.g., 'n=X implants'). The testing refers to meeting standard requirements (e.g., ASTM, ISO guidelines), which imply specific numbers of test units, but these are not provided in this summary document.
• Data Provenance: The testing was conducted by Dentsply Sirona (the manufacturer) and references previous FDA clearances (K numbers) and established standards. The data is part of the 510(k) submission to the FDA. The provenance of specific raw data (country of origin, retrospective/prospective) is not detailed in this summary.

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 document does not describe a process for establishing ground truth using human experts for the purpose of validating an AI/software device's diagnostic performance against human readers. The validation activity for the software (Atlantis® Abutment Milling) was to ensure its design limitations mirrored the internal CAD system and did not fall outside acceptable parameters.

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

• Not applicable. This is not a clinical study involving human interpretation or adjudication of findings.

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:

• No. The document explicitly states: "Clinical Tests Summary and Conclusion: Not applicable. There are no clinical tests submitted, referenced, or relied on in the 510(k) for a determination of substantial equivalence." Therefore, no MRMC study was conducted or reported.

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

• The "software validation" for "Atlantis® Abutment Milling" is a form of standalone performance evaluation for the CAD capabilities. It confirms that the software's design outputs (e.g., abutment geometry) from the 3Shape Abutment Designer Software conform to the established design envelope and limitations of Dentsply Sirona's internal CAD system (Virtual Abutment Design - VAD). This is a technical validation of the algorithm's design capability, not a diagnostic performance study.

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

• For the MR Safety testing, the ground truth or "reference standard" is the physical behavior of the device under MR conditions, measured against established ASTM standards and FDA guidance.
• For Biocompatibility, the ground truth is the biological response, evaluated against ISO standards.
• For Reprocessing, the ground truth is the effectiveness of sterilization and drying, validated against AAMI/ISO standards and FDA guidance.
• For CAD/CAM Software Validation, the "ground truth" for the 3Shape software is the "validated and locked design library" and "design limitations" of Dentsply Sirona's internal VAD software, ensuring the external software produces designs within the company's approved specifications.
• For Mechanical Performance (Fatigue Testing), the ground truth is the structural integrity and durability under dynamic loading, evaluated against ISO standards and FDA guidance.

8. The sample size for the training set:

• Not applicable. This is not an AI/ML device that requires a "training set" in the context of supervised learning for diagnostic tasks. The software referred to (3Shape Abutment Designer Software) is a CAD software for design, not a machine learning model for prediction or classification.

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

• Not applicable, as there is no "training set" in the machine learning sense described in this document. The "ground truth" for the CAD software's validation was its adherence to the manufacturer's established design rules and limitations.

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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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