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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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Astra Tech Implant System abutments are intended to be used in conjunction with the Astra Tech Implant System in fully edentulous or partially edentulous maxillary and/or mandibular arches to provide support for crowns, bridges or overdentures. Highly angled abutments on small diameter implants are not recommended for use in the molar region. ZirDesign is not recommended for use in the molar regions.

The Astra Tech Implant System has been modified to increase treatment options by adding new abutment shapes in titanium and zirconia. Both abutment designs are provided in multiple sizes with straight and angled versions. The hex interlocking anti-rotation mechanism for indexing with the implant remains unchanged from the predicate devices. As with the predicate devices, Astra Tech's Conical Seal Design™ is used for the internal connection with the implant to achieve a tight and stable interface.

The provided text describes modifications to the Astra Tech Implant System, specifically the addition of new abutment shapes, and asserts their substantial equivalence to predicate devices, but it does not contain acceptance criteria for device performance or a study proving that the device meets such criteria.

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than detailing performance against specific acceptance criteria for a novel device.

Here's why the requested information cannot be extracted from the provided text:

• No Acceptance Criteria: The document does not define any specific numerical or categorical acceptance criteria for performance metrics (e.g., strength, durability, fit).
• No Performance Study Details: While it states "Performance testing was provided to demonstrate substantial equivalence and included methods described in ISO 14801," it does not provide any results from this testing, nor does it detail the study design elements requested (sample size, data provenance, ground truth establishment, expert qualifications, etc.).
• Focus on Substantial Equivalence: The entire submission hinges on the argument that the modified device is "substantially equivalent" to existing predicate devices, implying that its performance is expected to be similar, rather than proving it meets new, pre-defined acceptance criteria.

Therefore, I cannot populate the table or provide the requested details because the input text does not contain this information.

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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 maxillary lateral incisors and mandibular lateral and central incisors. The prosthesis can be cement retained to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant.

This device is compatible with the Astra Tech OsseoSpeed 3.0 mm Implant.

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 restorations.

The Atlantis™ Abutments for Astra Tech OsseoSpeed 3.0 Implant System and abutment screws are made from Titanium grade Ti-6A1-4V ELI (Meets ASTM Standard F-136). The abutment is placed over the implant shoulder and is mounted into the implant with a screw. The abutments are compatible with Astra's 3.0 mm OsseoSpeed™ Implants.

This document is a 510(k) summary for the Atlantis™ Abutment for Astra Tech OsseoSpeed 3.0 Implant System and does not contain information about the acceptance criteria or a study proving that the device meets such criteria. A 510(k) submission generally focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance studies against specific acceptance criteria.

The document states:

• "The Atlantis™ Abutments for Astra OsseoSpeed 3.0 Implants are substantially equivalent in intended use, material, design and performance to the Atlantis Abutments tor Astra Implants cleared under K070833 and for the Astra Tech OsseoSpeed TM Narrow Implants cleared under K080396."

To answer the user's request, I would need a different type of document, such as a full study report or a design verification document, which is not provided here.

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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 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: Astra Tech Systems OsseoSpeed™ Implants 3.5 mm, 4.0mm, 4.5 mm and 5.0 mm diameters. 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. Also, 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 restorations. The Atlantis™ Abutments in Zirconia for Astra Implants is made of biocompatible material, yttria-stabilized tetragonal zirconia polycrystals (Y-TZP) and meets ISO Standards 6972 & 13356). The abutment screws are made from titanium grade Ti-6A1-V ELI and meets ASTM Standard F-136. The abutment is placed over the implant shoulder and is mounted into the implant with a screw. The abutments are compatible with the Astra Tech OsseoSpeed™ implants 3.5 mm, 4.0 mm, 4.5 mm and 5.0 mm diameters.

This 510(k) premarket notification for the Atlantis™ Abutment in Zirconia for Astra Implants does not include a study proving device performance against acceptance criteria in the way typically seen for diagnostic or AI-driven devices.

Instead, this submission is a claim of substantial equivalence to previously cleared predicate devices based on material, design, and intended use. The "acceptance criteria" here relate more to meeting established standards for biocompatibility and mechanical properties rather than performance in a clinical or diagnostic setting.

Here's an breakdown based on the provided text, highlighting what is (and isn't) present:

Acceptance Criteria and Device Performance (Based on provided text)

Further Information Based on the Document:

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

   • N/A. No "test set" in the context of performance data (e.g., clinical outcomes, diagnostic accuracy) is described. The submission relies on a comparison to predicate devices, material standards, and intended use.

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

   • N/A. No ground truth establishment by experts for a test set is described.

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

   • N/A. No adjudication method for a test set is described.

4. 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. This device is a dental implant abutment, not a diagnostic imaging device or an AI-driven tool for human readers. Therefore, an MRMC study is not applicable.

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

   • N/A. This is a physical medical device (dental abutment), not an algorithm or AI system.

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

   • N/A. For this type of 510(k) submission, the "ground truth" is largely established by adherence to recognized material standards (ISO, ASTM) and the established performance/safety profile of the predicate devices. There is no "ground truth" in the sense of clinical outcomes or pathology data specifically collected for this submission to prove its performance.

7. The sample size for the training set:

   • N/A. This is a physical medical device, not a machine learning model. There is no training set mentioned or implied.

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

   • N/A. As above, no training set is relevant here.

Summary of the Study/Evaluation described in the document:

The document describes a substantial equivalence claim rather than a "study" in the traditional sense of a clinical trial or performance evaluation against specific metrics. The "study" implicitly performed by the manufacturer, and reviewed by the FDA, involved:

• Comparison to Predicate Devices: The Atlantis™ Abutment in Zirconia for Astra Implants was compared to three predicate devices (K070833, K053384, K024111) to demonstrate equivalence in intended use, material, design, and performance. This is the primary method of evaluation for this 510(k)
• Material Characterization: The biocompatibility and composition of the materials (Y-TZP and Ti-6A1-V ELI) were likely verified against established international standards (ISO 6972, ISO 13356, ASTM F-136).
• Design Specifications: The design would have been reviewed to ensure it met specifications compatible with the Astra Tech OsseoSpeed™ implants and to verify that any design changes from predicate devices did not raise new questions of safety or effectiveness. This would include considerations for angled abutments and implant diameters.

The FDA's review and clearance signify their agreement that the provided information supports the claim of substantial equivalence, meaning the device is as safe and effective as the legally marketed predicate devices.

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