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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 Allied Biocompat 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 or screw retained to the abutment screw is intended to secure the Allied Dental Solutions abutment to the endosseous implant.

Allied Biocompat Abutments are compatible with the following

Implant Manufacturer: Nobel Biocare

Implant Line: Replace Select Straight and Select Straight One Stage, Replace Select Tapered one Stage

Implant Diameters: 3.5 (NP), 4.0 (RP), 5.0 (WP) and 6.0

Allied Biocompat patient-specific abutments are made from Ti-6Al-4V ELI which meets ASTM F136. Two abutment screw designs are included because the standard one does not fit the narrowest platform. The abutment is placed over the shoulder of the implant and fastened with the appropriate abutment screw. The patient-specific abutments designs share the same internal tri-lobe prosthetic interface but there are different implant platform diameters so there are 4 different diameters of abutment. The maximum angulation which can be ordered is 25°.

Allied Biocompat NB internal tri-lobe 3.5mm Allied Biocompat NB internal tri-lobe 4.0mm Allied Biocompat NB internal tri-lobe 5.0mm Allied Biocompat NB internal tri-lobe 6.0mm

These are patient-specific CAD/CAM abutments designed and fabricated under the manufacturing control of Allied Dental Solutions.

The provided text describes a 510(k) premarket notification for the "Allied Biocompat Abutment for Nobel Replace Interface." This document primarily focuses on demonstrating substantial equivalence to a predicate device, rather than outlining a study with specific acceptance criteria and detailed performance metrics for a novel medical device like an AI algorithm.

Therefore, many of the requested details about acceptance criteria, sample sizes, ground truth establishment, expert involvement, and MRMC studies are not applicable to this document. This submission is for a medical device (dental abutment) and relies on material and fatigue testing, not AI performance evaluation.

However, I can extract the available information related to the device's performance demonstration:

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

The document does not explicitly state "acceptance criteria" in the traditional sense of numerical targets for an AI algorithm's performance (e.g., sensitivity, specificity). Instead, it demonstrates compliance with a standard and equivalence to a predicate device.

2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The testing described (e.g., fatigue testing) would involve a sample of physical devices, but the specific number tested is not mentioned. The data provenance is laboratory testing rather than clinical data.

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 is a physical device, and "ground truth" refers to engineering specifications and material properties, not interpretations by medical experts.

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

Not applicable. This is a physical device.

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 device and not an AI algorithm.

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

Not applicable. This is a physical device and not an AI algorithm.

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: ISO 14801 for fatigue testing, ASTM F136 for material specifications, ISO 10993-5 for biocompatibility.
• Predicate device characteristics: Demonstrating that the new device performs comparably to a legally marketed predicate device (Atlantis Abutments K053654 and K981858, among others) in terms of materials, design, and fatigue performance.
• Validated laboratory methods: For sterilization and fit analysis.

8. The sample size for the training set

Not applicable. This is a physical device, not an AI algorithm requiring a training set.

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

Not applicable.

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The Atlantis Abutment is intended for use as an accessory to 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 3i Osseotite™ NT Certain™ (tapered wall) Implants with 4.0mm, 5.0mm and 6.0mm 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 3i Certain Interface is made of biocompatible material, yttria-stabilized tetragonal zirconia polycrystals (Y-TZP) and meets ISO Standards (6972 & 13356). The abutment screw is 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 3i Osseotite NT® Certain™ Implants (tapered wall) with 4.0 mm (RP), 5.0 mm (WP) and 6.0 mm (WP) diameters.

The provided text focuses on regulatory approval (510(k) submission) for a dental abutment. It describes the device, its intended use, and claims substantial equivalence to legally marketed predicate devices. However, it does not contain information about specific performance acceptance criteria or a study that directly proves the device meets those criteria, as typically found in a clinical or performance study report.

The document states the device "meets ISO Standards (6972 & 13356)" for its material (yttria-stabilized tetragonal zirconia polycrystals - Y-TZP) and its abutment screw material "Meets ASTM Standard F-136" (Titanium grade Ti-6A1-4V ELI). These are material specifications, not performance criteria for the assembled device.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and the reported device performance: This information is not present in the provided text.
2. Sample size used for the test set and the data provenance: No performance testing data is provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth establishment/expert review is mentioned as part of a performance study.
4. Adjudication method for the test set: Not applicable as no performance test data is provided.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No MRMC study is mentioned.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable as the device is a physical dental abutment, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable as no performance test data is provided.
8. The sample size for the training set: Not applicable as no AI/algorithm training is involved.
9. How the ground truth for the training set was established: Not applicable as no AI/algorithm training is involved.

The document is a regulatory submission demonstrating substantial equivalence, relying on the fact that the new device has similar materials, design, and intended use as devices already on the market, which are presumed to be safe and effective. It does not include a detailed performance study with acceptance criteria.

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The Atlantis Abutment is intended for use as an accessory to 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 maxillated 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: Nobel Biocare Replace Select Straight, Replace Select Straight One Stage, Replace Select Tapered and Replace Select Tapered One Stage.

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 Nobel Replace Interface 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 Nobel Replace® Select Straight, Replace Select Straight One Stage, Replace Select Tapered and Replace Select Tapered One Stage for the 3.5 mm (NP), 4.3 mm (RP), 5.0 mm (WP) and 6.0 mm (WP) Implants.

The provided text is a 510(k) summary for the Atlantis™ Abutment for Nobel Replace Interface. This document focuses on establishing substantial equivalence to previously cleared devices rather than presenting a study with acceptance criteria and performance metrics in the way a clinical trial or software validation study would.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC study, training set sample size, how training set ground truth was established) are not applicable (N/A) because this submission format does not require such detailed efficacy or performance study data.

The acceptance criteria for a 510(k) submission revolve around demonstrating substantial equivalence to a predicate device. This is primarily achieved through comparisons of intended use, material, design, and performance, rather than through specific quantitative metrics of a clinical study.

Here's a breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• N/A. This document does not describe a clinical performance study with a distinct "test set" of patients or samples in the way an AI/software or clinical trial report would. The "study" here is a demonstration of substantial equivalence to predicate devices, likely through engineering bench testing and comparison, not patient data analysis.

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)

• N/A. Ground truth is not established in the context of this 510(k) summary. The evaluation relies on established device specifications, materials standards (ASTM), and comparison to existing cleared devices.

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

• N/A. Not applicable as there is no human adjudication of a "test set" in this type of submission.

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

• N/A. This device is a dental implant abutment, not an AI or imaging diagnostic device. Therefore, MRMC studies are not relevant.

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

• N/A. This device is not an algorithm.

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

• N/A. For this type of device and submission, "ground truth" as it relates to clinical outcomes or diagnostic accuracy is not the primary focus. Instead, the "truth" against which the device is measured is its adherence to material specifications, design compatibility, and established safety/performance characteristics demonstrated by predicate devices, typically through bench testing and engineering analysis (though specific results are not detailed in this summary).

8. The sample size for the training set

• N/A. There is no "training set" as this is not an AI or machine learning device.

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

• N/A. There is no "training set" as this is not an AI or machine learning device.

Ask a specific question about this device

The Atlantis Abutment is intended for use as an accessory to 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.

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 3i Certain™ Implant 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 3i Certain Standard Implants with 4.1mm, 5.0mm, 6.0mm diameters; the OSSEOTITE® XP Certain Implants with 5.0mm and 6.0mm diameters; and the OSSEOTITE® NT® Certain™ Implants with 4.0mm, 5.0mm and 6.0mm diameters.

The provided text describes a 510(k) premarket notification for a medical device called the Atlantis™ Abutment for 3i Certain™ Implant. This type of submission aims to demonstrate that a new device is substantially equivalent to a legally marketed predicate device.

Therefore, the document does not contain information regarding:

• Acceptance criteria and reported device performance in a table. The summary focuses on equivalence to a predicate device rather than specific performance metrics against pre-defined acceptance criteria.
• A study that proves the device meets acceptance criteria. No specific study design, methodology, or results are presented that would demonstrate the device meeting particular performance targets.
• Sample size and data provenance for a test set.
• Number and qualifications of experts for ground truth.
• Adjudication method for the test set.
• Multi-reader multi-case (MRMC) comparative effectiveness study.
• Standalone (algorithm only) performance study.
• Type of ground truth used (e.g., pathology, outcomes data).
• Sample size for the training set.
• How ground truth for the training set was established.

Instead, the document focuses on:

• Device Identification: Trade Name, Common Name, Classification Name, Regulation Number, Product Code.
• Predicate Device: Identification of the legally marketed device to which equivalence is claimed.
• Description of the Device: Material used (Titanium grade Ti-6A1-4V ELI), compatibility with various implant diameters, and its function as an abutment and abutment screw.
• Intended Use: As an accessory to an endosseous implant to support a prosthetic reconstruction in partially or completely edentulous patients, supporting single and multiple tooth prostheses in the mandible or maxilla, with cement-retained prostheses.
• Basis for Substantial Equivalence: Stating that the device is substantially equivalent in intended use, material, design, and performance to the predicate device cleared under K981858.
• Regulatory Outcome: FDA's determination of substantial equivalence, allowing the device to be marketed.

In summary, this document is a regulatory submission demonstrating equivalence, not a clinical or performance study report with specific acceptance criteria and detailed study results. Therefore, it does not provide the information requested in the prompt regarding acceptance criteria, study details, and ground truth establishment.

Ask a specific question about this device

The Atlantis Abutment is intended for use as an accessory to 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.

The Atlantis™ Abutments for Straumann Interface 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 Straumann Standard Regular Neck (RN) implants with 3.3, 4.1, and 4.8mm diameters; Standard Plus Regular Neck (RN) with 3.3, 4.1, and 4.8mm diameters and the Tapered Effect Regular Neck (RN) with the 3.3 and 4.1mm diameters.

The provided document is limited in scope and does not contain detailed information about acceptance criteria, a specific study proving device performance, or the methodologies typically associated with such studies (like sample sizes, ground truth establishment, or expert involvement).

The document is a pre-market notification (510(k) summary) for the Atlantis™ Abutment for Straumann Interface. It primarily focuses on establishing substantial equivalence to a predicate device (Atlantis Abutment and Abutment Screw, K981858) based on intended use, material, design, and performance.

Therefore, I cannot provide a detailed response to most of your questions as the information is not present in the provided text.

Here's what can be extracted based on the given document:

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

This information is not provided in the document. The filing focuses on substantial equivalence to a predicate device rather than presenting specific quantitative acceptance criteria and performance data from a new study.

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

This information is not provided in the document. No specific test set or study data is presented.

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

This information is not provided in the document. No information about ground truth establishment or expert involvement in a study is mentioned.

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

This information is not provided in the document. No adjudication method is mentioned as there's no described test set or study requiring it.

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

This information is not provided in the document. The device is a dental implant abutment, not an AI-assisted diagnostic tool, so an MRMC study related to AI assistance would not be applicable or expected.

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

This is not applicable. The device is a physical dental abutment, not an algorithm.

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

This information is not provided in the document. No ground truth is discussed as there is no mention of a study to validate performance against a ground truth. The basis for clearance is "substantial equivalence" to a predicate device.

8. The sample size for the training set

This information is not provided in the document. There is no mention of a training set as this is not a machine learning device.

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

This information is not provided in the document. There is no training set and thus no ground truth establishment for one.

In summary, the provided document is a 510(k) summary for a physical medical device (dental abutment) seeking clearance based on substantial equivalence to a predicate device. It does not describe a new clinical study with acceptance criteria, performance data, or ground truth establishment in the manner requested by your questions, which are more typically associated with software as a medical device or AI-driven diagnostic tools.

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The 3i Patient-Specific Dental Abutment and Overdenture Bars are intended for use as an accessory to an endosseous dental implant to support a prosthetic device in a partially or edentulous patient. It is intended for use to support single and multiple tooth prostheses, in the mandible or maxilla. The prostheses can be screw or cement retained to the abutment.

The 3i Patient-Specific Dental Abutments and Overdenture Bars are designed to match individual patients.

This is a 510(k) premarket notification for a dental device, not an AI/ML medical device. As such, the document does not contain the information required to answer the questions regarding acceptance criteria and studies that prove the device meets them in the context of AI/ML performance.

The document primarily focuses on establishing substantial equivalence to predicate devices based on overall design and intended use, rather than presenting a performance study with acceptance criteria for an AI algorithm.

Therefore, most of the requested information (like sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth types for AI) is not applicable or present in this submission.

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