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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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Implants:
The Astra Tech Dental Implants are intended for both one- and two-stage surgical procedures in the following situations and with the following clinical protocols:

• replacing single and multiple missing teeth in the mandible and maxilla, ●
• immediate placement in extraction sites and in situations with a partially or completely . healed alveolar ridge,
• especially indicated for use in soft bone applications where implants with other implant ● surface treatments may be less effective,
• immediate loading in all indications, except in single tooth situations on implants shorter . than 8 mm or in soft bone (type IV) where implant stability may be difficult to obtain and immediate loading may not be appropriate.

The intended use for OsseoSpeed™ Plus 3.0S is limited to replacement of maxillary lateral incisors and mandibular incisors.

Abutments:
Astra Tech Implant System Plus abutments are intended to be used in conjunction with Astra Tech Implant System Plus in fully edentulous or partially edentulous maxillary and/or mandibular arches to provide support for crowns, bridges or overdentures.

Atlantis Abutments:
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 prostheses, in the mandible or maxilla. The prosthesis can be cemented, screw retained or friction fit to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant.

The Atlantis™ Crown Abutment in Zirconia is intended for use with an endosseous implant to function as a substructure that also serves as the final restoration, in partially or completely edentulous patients. The prosthesis is screw retained. The abutment screw is intended to secure the crown abutment to the endosseous implant.

The purpose of this submission is to expand the OsseoSpeed™ Plus Implant System to include all the components of the previously cleared OsseoSpeed System. The OsseoSpeed Plus Implant System, cleared September 26, 2011 under K111287, has the same design as the OsseoSpeed system, except for addition of an anti-rotation feature to the implant/abutment interface.

The OsseoSpeed Plus System includes implants with diameters ranging from Ø3.0 mm to Ø5.4 mm and lengths ranging from 6 mm to 17 mm. Radiographic guides are available for all implant sizes. Abutments sizes range from Ø3.0 mm to Ø5.4 mm in straight and angled designs ranging from 15° to 30°. Abutment designs include coverscrews, healing abutments, temporary abutments, cast-to abutments, ball abutments, straight and angled abutments.

This 510(k) Premarket Notification for the OsseoSpeed™ Plus Dental Implant System primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices. Therefore, the information provided does not detail specific acceptance criteria for a new clinical study and a study that proves the device meets those criteria, as one would typically find for a novel device.

The submission is for an expansion of an existing system (OsseoSpeed™ Plus) to include components from the previously cleared OsseoSpeed System (K111287). The core argument for substantial equivalence is based on the device having the "same intended use and design principles" and "same technological characteristics" as predicate devices, supported by non-clinical testing.

Here's an analysis of what is available in the document, acknowledging that typical clinical study acceptance criteria and results are not present:

1. Table of Acceptance Criteria and Reported Device Performance

As this submission relies on substantial equivalence and non-clinical testing, explicit acceptance criteria tied to a clinical performance study with defined metrics (e.g., success rates, complication rates) are not provided in the document.

The "acceptance criteria" here are implicitly linked to demonstrating that the OsseoSpeed™ Plus system is as safe and effective as the predicate devices. The non-clinical data presented aims to show that any differences in technological characteristics do not raise new issues of safety or efficacy.

2. Sample Size for the Test Set and Data Provenance

• Sample Size for Test Set: Not applicable in the context of this 510(k) submission, as there is no specific clinical test set described from a prospective study. The evaluation relies on non-clinical engineering and bench testing data, and the historical performance of the predicate devices. The document does not specify sample sizes for the non-clinical tests, other than referencing the types of tests performed (e.g., ISO 14801).
• Data Provenance: The referenced predicate devices would have been previously marketed (interstate commerce prior to May 28, 1976, or reclassified devices). The non-clinical testing data would typically be generated in a lab setting by the manufacturer (Astra Tech AB, Sweden, or its testing partners).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

• This question is not applicable for this submission. The ground truth, in the absence of a clinical study, is the established safety and efficacy of the predicate devices, supported by the non-clinical testing confirming that the new device variant performs similarly. Expert consensus on clinical outcomes for a novel test set is not described.

4. Adjudication Method for the Test Set

• Not applicable. There is no clinical test set requiring an adjudication method by experts for ground truth establishment.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size

• No. This type of study is not mentioned or implied in this 510(k) submission, as it focuses on dental implants, not image-based diagnostic aids or similar devices where MRMC studies are common.

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

• Not applicable. The OsseoSpeed™ Plus is a physical dental implant system, not a software algorithm or AI-driven device.

7. The type of ground truth used

• The "ground truth" for this 510(k) clearance is primarily:
  • The established safety and efficacy profile of the legally marketed predicate devices.
  • Bench test results and engineering analyses (e.g., mechanical strength, dimensional accuracy, surface characteristics) demonstrating that the subject device performs comparably to the predicates and meets relevant standards (like ISO 14801).
  • The regulatory precedent set by the predicate devices.

8. The sample size for the training set

• Not applicable. There is no "training set" in the context of a machine learning algorithm for this physical device. If referring to product development and testing, the sample size for non-clinical tests would be defined by engineering standards and internal validation protocols, but specific numbers are not provided in this summary.

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

• Not applicable. As there is no training set for an AI algorithm, this question doesn't apply. The "ground truth" for the overall submission is based on regulatory precedent and engineering validation against established standards and predicate devices.

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