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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 cemented, screw retained or friction fit 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:
The Atlantis Abutment in Zirconia for Dentsply Ankylos Implant is compatible with the Dentsply Ankylos 3.5mm, 4.5mm, 5.5mm and 7.0mm Implants.

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.

This device is compatible with the following manufacturers' implant systems:
the Dentsply Ankylos 3.5mm, 4.5mm, 5.5mm and 7.0mm Implants.

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 on small diameter implants are intended for the anterior region of the mouth only.

The Atlantis Abutment and Atlantis™ Crown Abutment in Zirconia for Dentsply AnkylosImplant is compatible with the Dentsply Ankylos 3.5mm, 4.5mm, 5.5mm and 7.0mm Implants.

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 angulated abutments on small implants are to be used for the anterior region of the mouth only.

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 for cemented, screw retained or friction fit restorations. The Atlantis™ Abutment and Atlantis™ Crown Abutment in Zirconia for Dentsply Ankylos 3.5mm, 4.5mm, 5.5mm and 7.0mm Implants is made of biocompatible material, yttria-stabilized tetragonal for the zirconia polycrystals (Y-TZP) ( meets ISO Standards 6972 & 13356). Zirconia may have variation in shade. The abutment screw is made of Titanium grade Ti-6A1-4V ELI (meets ASTM Standard F-136). The zirconia abutments are placed over the implant shoulder and are mounted into the implant with a titanium screw.

The provided document is a 510(k) summary for a medical device (dental abutments) and does not contain information related to AI/ML device acceptance criteria or studies as typically found in submissions for AI-powered diagnostics or medical image analysis.

The document describes the "Atlantis™ Abutment and Atlantis™ Crown Abutment in Zirconia for Dentsply Ankylos Implant" and its substantial equivalence to a predicate device. The "study" mentioned is non-clinical testing to demonstrate performance characteristics, not a clinical trial or AI/ML performance study.

Therefore, most of the requested information (acceptance criteria for AI, sample sizes for test/training sets, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance) is not applicable to this type of device submission.

Here's a breakdown of the relevant information from the document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't provide explicit "acceptance criteria" in the format of thresholds for metrics like sensitivity, specificity, or F1-score as you would see for an AI/ML device. Instead, the acceptance is based on demonstrating substantial equivalence to an already legally marketed predicate device (K#101004). The performance is demonstrated through non-clinical mechanical testing, ensuring the device can withstand intended forces.

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

• Test Set Sample Size: Not explicitly stated as a "test set" in the context of clinical or AI/ML performance evaluation. The "worst case scenario" implant assemblies used for static and fatigue testing would constitute the "test set" for the mechanical performance. The exact number of samples for these mechanical tests is not provided in this summary.
• Data Provenance: The mechanical testing would have been conducted in a laboratory setting, likely by the manufacturer or a contracted lab. Country of origin of the data is not specified but is presumed to be relevant to the manufacturer (Astra Tech Inc., Waltham, Massachusetts, USA). This is retrospective in the sense that the test results are reported after the tests were conducted prior to submission.

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

• Not applicable. Ground truth in the context of AI/ML evaluation (e.g., expert consensus on medical images) is not relevant for this mechanical device submission. The "ground truth" for mechanical testing is established by engineering standards and measurements.

4. Adjudication method for the test set:

• Not applicable. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth from multiple human reviewers, which is not relevant here. Mechanical test results are typically objective measurements against predefined engineering specifications.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

• No. This is a mechanical device, not an AI/ML diagnostic.

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

• No. This is a physical medical device, not an algorithm.

7. The type of ground truth used:

• For the mechanical performance component, the "ground truth" is derived from established engineering standards and material properties, along with the results of static and fatigue compression testing measured against performance specifications that demonstrate the device "performs as intended."

8. The sample size for the training set:

• Not applicable. There is no AI/ML component or "training set" in this submission.

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

• Not applicable.

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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 endentulous patient. It is intended for use to support single and multiple tooth prosthesis, in the mandible or maxilla. The prosthesis can be cemented or screw 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:

The titanium and zirconia abutments are compatible with the 3.8mm, 4.5mm, 5.5mm, and 6.5mm Keystone Genesis Tapered and Straight Implants.

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.

This device is compatible with the following manufacturers' implant systems:

the 3.8mm, 4.5mm, 5.5mm, and 6.5mm Keystone Genesis Tapered and Straight Implants.

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 on small diameter implants are intended for the anterior region of the mouth only.

The devices covered in this submission are abutments which are placed into the dental implant to provide support for a prosthetic restoration. The titanium and zirconia abutments are indicated for cemented or screw retained restorations. The crown abutment in zirconia is indicated for screw retained restorations. The titanium Atlantis™ Abutment for Keystone Genesis Implant and abutment screw are made of Titanium grade Ti-6A1-4V ELI (meets ASTM Standard F-136) for the 3.8mm, 4.5mm, 5.5mm and 6.5mm sizes. In addition, the zircoina Atlantis™ Abutment for Keystone Genesis Implant and the Atlantis™ Crown Abutment in Zirconia for the 3.8mm. 4.5mm. 5.5mm and 6.5mm sizes are made of biocompatible material, yttriastabilized tetragonal zirconia polycrystals (Y-TZP) and meets ISO Standards 6972 & 13356). Zirconia may have variation in shade. The titanium and zirconia abutments are placed over the implant shoulder and are mounted into the implant with a titanium screw.

This document describes a 510(k) premarket notification for the Atlantis™ Abutment and Atlantis™ Crown Abutment in Zirconia for Keystone Genesis Implant. This is a medical device submission, and therefore, the information provided is focused on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove performance against specific acceptance criteria for a novel device.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

For this type of 510(k) submission, the "acceptance criteria" are typically defined by demonstrating that the new device is "substantially equivalent" to legally marketed predicate devices. This equivalence is primarily shown through comparisons of technological characteristics, intended use, and performance characteristics. The acceptance criteria aren't explicitly numerical thresholds as one might see for a diagnostic AI.

Here's a table based on the provided "Substantial Equivalence Summary" (Table 1):

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

• Sample Size: The document mentions "worst case scenario" implant assemblies were tested, but it does not specify the numerical sample size used for the static and fatigue compression testing.
• Data Provenance: The testing was conducted as part of the premarket submission by Astra Tech Inc. It is internal testing to demonstrate the device's compatibility and performance. The document does not specify the country of origin of the data further than implying it's internal to the manufacturer's R&D process. It is prospective data generated specifically for this submission.

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

This information is not applicable and not provided in the context of this 510(k) submission. For medical devices like dental abutments, "ground truth" is typically established through direct physical and mechanical testing (e.g., material properties, static and fatigue strength) against engineering standards and comparison to predicate devices, rather than expert consensus on observational data.

4. Adjudication method for the test set

This information is not applicable and not provided. Adjudication methods like 2+1 or 3+1 are used in studies where human readers evaluate cases (e.g., medical images) and their interpretations need to be reconciled. This submission focuses on physical performance testing.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic or assistive devices where human performance with and without AI assistance is being compared. The device in question is a physical dental abutment, not an AI diagnostic tool.

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

No, a standalone performance evaluation of an algorithm was not done. This device is a physical product, not a software algorithm.

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

The "ground truth" for the performance of the Atlantis™ Abutment and Atlantis™ Crown Abutment is established through physical and mechanical testing (static and fatigue compression testing) designed to simulate the in-vivo environment and demonstrate that the device performs as intended and is comparable to previously cleared predicate devices. The "truth" is based on meeting engineering specifications and demonstrating mechanical integrity under specified loads.

8. The sample size for the training set

This information is not applicable and not provided. There is no "training set" in the context of developing and validating a physical dental abutment. Training sets are used for machine learning algorithms.

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

This information is not applicable and not provided for the same reason as in point 8.

Ask a specific question about this device

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:

The titanium and zirconia abutments are compatible with the Nobel Biocare's NobelActive Implants: NP 3.3mm, RP 4.3mm and 5.0 mm sizes

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™ Abutment for Nobel Biocare Active Implant and abutment screw are made from Titanium grade Ti-6A1-4V ELI (meets ASTM Standard F-136) for the 3.5mm, 4.3mm and 5.0mm sizes. In addition, the Atlantis™ Abutment for Nobel Biocare Active Implant for the 3.5mm, 4.3mm and 5.0mm sizes, also are made of the biocompatible material, yttria-stabilized tetragonal zirconia polycrystals (Y-TZP) (meets ISO Standards 6072 & 13356). Zirconia may have a variation in shade. The titanium and the zirconium abutments are placed over the implant shoulder and are mounted into the implant with a titanium screw.

The provided text is a 510(k) premarket notification for a dental abutment. The primary purpose of this type of submission is to demonstrate substantial equivalence to a legally marketed predicate device, rather than to establish safety and effectiveness through clinical trials with detailed acceptance criteria and performance studies for a novel device.

Therefore, the document does not contain the kind of detailed information requested in your prompt regarding acceptance criteria, specific device performance metrics, sample sizes for test sets, expert ground truth establishment, or clinical study designs (like MRMC or standalone performance). The "study" proving the device meets acceptance criteria is fundamentally a demonstration of equivalence to the predicate, primarily through material and design specifications and intended use.

Here's an analysis based on the information provided, explaining why certain sections of your request cannot be fulfilled:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly stated in terms of quantitative performance metrics for the device itself (e.g., specific force resistance values, wear rates, etc.). The "acceptance criteria" for this submission are fundamentally demonstrating that the Atlantis™ Abutment for Nobel Active Implant has the same intended use, material, and design characteristics as the predicate devices, and performs similarly in terms of its intended function as an endosseous dental implant abutment.
• Reported Device Performance: No specific quantitative performance data (e.g., stress testing results, fatigue life in cycles) is reported in this summary. The performance is implied to be "substantially equivalent" to the predicate.

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

• Sample Size: Not applicable in the context of this 510(k) summary. This document does not describe a clinical performance study with a "test set" of patients or images. Instead, it relies on demonstrating substantial equivalence to pre-existing, legally marketed devices.
• Data Provenance: Not applicable. There is no patient data (retrospective or prospective) described in this submission.

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

• Not applicable. There is no "test set" requiring expert ground truth in this type of submission.

4. Adjudication method for the test set:

• Not applicable. There is no patient-level or image-level test set that would require adjudication.

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 medical device for tooth restoration, not an AI-powered diagnostic or assistive tool for human readers.

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

• Not applicable. This is a physical medical device (an abutment), not an algorithm or AI system.

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

• Not applicable. The "ground truth" for this submission is the established safety and effectiveness of the predicate devices, based on their prior marketing clearance and use. The new device demonstrates conformance to established engineering specifications and biocompatibility standards rather than clinical ground truth from patient outcomes.

8. The sample size for the training set:

• Not applicable. This is not an AI/machine learning device.

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

• Not applicable. This is not an AI/machine learning device.

In summary: K093483 is a 510(k) premarket notification for a dental abutment. The "study" demonstrating that it meets "acceptance criteria" is the comprehensive technical and regulatory documentation showing its substantial equivalence to previously cleared predicate devices (K071370 and K072129) in terms of intended use, materials, and design. It is not a clinical trial with performance metrics typically associated with novel or AI-driven diagnostic devices.

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