(172 days)
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.
| Acceptance Criteria (Implied by Predicate Equivalence & Standards) | Reported Device Performance (ATLANTIS™ Crown) |
|---|---|
| Material: Y-TZP | Material: Y-TZP (Same as primary predicate Cercon® ht and reference predicate ATLANTIS™ Crown Abutment in Zirconia) |
| Primary Predicate Performance (Cercon® ht, K112152): | Substantially Equivalent to Predicate: The ATLANTIS™ Crown "can be delivered as a full contour crown or as a cut-back substructure onto which porcelain will be added by the customer," which is the same as the Cercon® ht. |
| **Reference Predicate Performance (ATLANTIS™ Crown Abutment in | Substantially Equivalent to Predicate: Material and CAD/CAM milling process are identical to the ATLANTIS™ Crown Abutment in Zirconia (K110356). |
| Zirconia, K110356): | |
| Flexural Strength: Must meet ISO 6872 requirements. | Flexural Strength: "Results showed that the requirements of the standard ISO 6872 Dentistry Ceramic Materials were fulfilled." (Testing done according to ISO 14704 and ASTM C1161 on the Zirconia material). |
| Fracture Toughness: Tested according to ISO 6872 requirements. | Fracture Toughness: "Tested and completed according to the requirements specified in ISO 6872." |
| Chemical Solubility: Tested according to ISO 6872 requirements. | Chemical Solubility: "Tested and completed according to the requirements specified in ISO 6872." |
| Radioactivity Concentration: Tested according to ISO 6872 | Radioactivity Concentration: "Tested and completed according to the requirements specified in ISO 6872." |
| requirements. | |
| Coefficient of Thermal Expansion: Tested according to ISO 6872 | Coefficient of Thermal Expansion: "Tested and completed according to the requirements specified in ISO 6872." |
| requirements. | |
| Biocompatibility: Demonstrated by equivalence. | Biocompatibility: "The material used for the ATLANTIS™ Crown and the manufacturing process is the same as used for the predicate device ATLANTIS™ Crown Abutment in Zirconia, K 110356. Therefore no additional biocompatibility testing has been performed." (Implies it meets the biocompatibility established for K110356 due to identical material and manufacturing). |
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:
- 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.
- 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.
- 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.
- 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.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is a physical prosthetic device.
- 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.
- The sample size for the training set: Not applicable. There is no "training set" as this is not an AI/ML model.
- How the ground truth for the training set was established: Not applicable. There is no "training set" or corresponding ground truth establishment process.
§ 872.6660 Porcelain powder for clinical use.
(a)
Identification. Porcelain powder for clinical use is a device consisting of a mixture of kaolin, felspar, quartz, or other substances intended for use in the production of artificial teeth in fixed or removable dentures, of jacket crowns, facings, and veneers. The device is used in prosthetic dentistry by heating the powder mixture to a high temperature in an oven to produce a hard prosthesis with a glass-like finish.(b)
Classification. Class II.