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The ATLANTIS™ Crown is intended for use with an ATLANTIS™ Abutment and an endosseous implant to function as a substructure that also serves as the final restoration, in a partially or completely edentulous patient.

The ATLANTIS™ Crown is a patient-specific dental prosthetic component intended for use with an ATLANTISTM Abutment, abutment screw, and an endosseous implant to support a single-tooth prosthetic restoration. The ATLANTIS™ Crown is made of yttria stabilized zirconia powder (Y-TZP) and fabricated according to the clinician's prescription using CAD/CAM technology. The crown can be delivered as a full contour crown or as a cut-back substructure onto which porcelain will be added by the customer. The ATLANTIS™ Crown is finally cemented to the ATLANTIS™ Abutment.

This document describes a 510(k) premarket notification for the ATLANTIS™ Crown, a patient-specific dental prosthetic component. The information provided heavily focuses on comparing the proposed device to predicate devices to establish substantial equivalence, rather than detailing a specific clinical study with acceptance criteria for a novel device.

Therefore, it is important to note that the input document does NOT describe the acceptance criteria and a study that proves the device meets those acceptance criteria in the typical sense for an AI/ML device.

Instead, the document demonstrates that the ATLANTIS™ Crown is substantially equivalent to a legally marketed predicate device based on its intended use, technological characteristics (material, design, manufacturing), and non-clinical performance data (flexural strength, fracture toughness, chemical solubility, radioactivity concentration, and coefficient of thermal expansion).

Here's an analysis based on the available information, addressing the requested points where possible, and noting where information is not present in the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in the context of a performance study for the ATLANTIS™ Crown as a new device with novel performance claims to be evaluated. Instead, it relies on demonstrating that the ATLANTIS™ Crown meets the established performance characteristics of its predicate devices and complies with relevant standards.

Regarding the remaining points:

The provided document is a 510(k) summary for a medical device (ATLANTIS™ Crown) which is a physical product, not an AI/ML diagnostic or assistive tool. Therefore, many of the requested points related to AI/ML device studies (sample sizes for test/training sets, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, standalone performance, ground truth types) are not applicable and are not found in this document.

Specific responses to the remaining points based on the understanding that this is not an AI/ML device document:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. This document reports non-clinical material characterization data (flexural strength, fracture toughness, etc.) against established standards (ISO, ASTM), not a clinical trial with a test set of patient 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. "Ground truth" in the context of clinical or diagnostic AI/ML studies is not relevant here. Material properties are measured against physical standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Material testing involves scientific measurement and comparison to quantitative standards, not expert 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 physical prosthetic device, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is a physical prosthetic device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable in the AI/ML sense. The "ground truth" for material properties is the defined limits and test methods of international standards like ISO 6872.
8. The sample size for the training set: Not applicable. There is no "training set" as this is not an AI/ML model.
9. How the ground truth for the training set was established: Not applicable. There is no "training set" or corresponding ground truth establishment process.

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The Atlantis Crown Abutment in Zirconia is intended for use with an endosseus implant to function as a substructure that also serves as the final restoration, in a partially or completely edentulous patient. 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:

Astra Tech Microthread ST 3.5mm, 4.0mm, 4.5mm and 5.0mm 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 device covered in this submission is a single restorative component for dental implants that integrates all aspects of the coping and abutment functionalities. The device has a crown shape exterior which allows the porcelain to be applied directly to the surface of the screw retained abutment and provides support for the described prosthetic restoration. The Atlantis Crown Abutment in Zirconia design is different than an Atlantis Abutment for cement-retained restoration in that the basis for its individualized design is the final crown.

The subject crown abutment is indicated for screw retained restorations. The Atlantis™ Crown Abutment in Zirconia is made of biocompatible material, yttria-stabilized tetragonal zirconia polycrystals (Y-TZP) and meets ISO Standards 6972 & 13356. Zirconia may have variation in shade. The abutment screw is made of Titanium grade Ti-6A1-4V ELI and complies with ASTM Standard F-136. The zirconia screw retained abutments are placed over the implant shoulder and are mounted into the implant with the titanium screw.

This document describes a 510(k) premarket notification for the "Atlantis™ Crown Abutment in Zirconia," a dental implant component. The information provided outlines the device's administrative details, intended use, device description, and its equivalence to a previously marketed device. The primary study described is a non-clinical test.

Here's a breakdown of the requested information based on the provided text:

Acceptance Criteria and Device Performance Study

The acceptance criteria for the Atlantis™ Crown Abutment in Zirconia are based on demonstrating substantial equivalence to a predicate device (Atlantis™ Abutment for Astra Implants cleared under K071946) and performance as intended under specific testing conditions.

1. Table of Acceptance Criteria and Reported Device Performance

• Predicate Device: Titanium Alloy (screw) and Biocompatible ceramic material (abutment). |
  | - Performance Characteristics (functionality) | - Atlantis™ Crown Abutment in Zirconia: Allows the prosthesis to be screw-retained to the endosseous implant.
• Predicate Device: Allows the prosthesis to be cemented or screw-retained to abutment; abutment screw secures abutment to the endosseous implant. (Note: The new device is specifically screw-retained, a subset of the predicate's capability regarding connection to the abutment, but both secure to the implant via screw) |
  | - Intended Use | - Atlantis™ Crown Abutment in Zirconia: Intended for use with an endosseous implant as a substructure functioning as the final, screw-retained restoration in partially/completely edentulous patients. Abutment screw secures to the implant.
• Predicate Device: Intended for use with an endosseous implant to support a prosthetic device in partially/completely edentulous patients, supporting single or multiple tooth prosthesis in mandible or maxilla. |
  | Performance as Intended (Non-clinical Testing): | |
  | - Withstand Static Compression | "Test results demonstrate that the Atlantis Crown Abutment is compatible with the Astra implants and the implant system supported appropriate static... test loads demonstrating that the implant system performs as intended." |
  | - Withstand Fatigue Compression | "Test results demonstrate that the Atlantis Crown Abutment is compatible with the Astra implants and the implant system supported appropriate... fatigue test loads demonstrating that the implant system performs as intended." |
  | - Compatibility with Astra Implants | "Test results demonstrate that the Atlantis Crown Abutment is compatible with the Astra implants..." |

2. Sample Size for the Test Set and Data Provenance

The study referenced is a non-clinical bench test. The text states:

• "Static and fatigue compression testing was conducted on "worst case scenario" implant assemblies for the Atlantis angled zirconia crown abutments with the Astra implant."
• Sample Size: The exact number of "worst case scenario" implant assemblies tested is not specified in the provided text.
• Data Provenance: The testing appears to be conducted by the manufacturer, Astra Tech Inc., as part of their premarket notification. This is a pre-clinical/bench test, not human patient data, so concepts like "country of origin of data" or "retrospective/prospective" in the typical clinical sense are not applicable.

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

This was a non-clinical bench test involving physical components and engineering analyses. Therefore, no human "experts" were used to establish ground truth in the context of clinical interpretation or diagnosis. The "ground truth" was established by the physical testing conditions and engineering standards/methods relevant to static and fatigue compression testing of dental implant systems.

4. Adjudication Method for the Test Set

Not applicable. As a non-clinical bench test without human assessors making judgments, there was no need for an adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This device is a physical dental implant component, not an imaging or diagnostic device that would involve human readers interpreting cases.

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

This refers to an AI/algorithm performance. No, this is not applicable as the device is a physical dental implant substructure, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical testing was based on:

• Engineering Standards and Specifications: The test loads applied, and the definition of failure or performance within the static and fatigue compression tests, would be based on established engineering principles and potentially relevant ISO or ASTM standards for dental implant components.
• Predicate Device Equivalence: A significant part of the "ground truth" for regulatory clearance was the demonstration of substantial equivalence to the previously cleared predicate device (K071946) in terms of materials, intended use, and performance characteristics.

8. The Sample Size for the Training Set

Not applicable. This is a physical device, and therefore there is no "training set" in the context of machine learning or algorithms.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this type of device.

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