(269 days)
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 or screw retained to the abutment. The 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 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 attachmentretained by friction fit to the abutment. The abutment screw is intended to secure the ATLANTIS™ Conus Abutment to the endosseous implant.
ATLANTIS™ Abutment for NobelActive 3.0 is compatible with the NobelActive 3.0 implant.
ATLANTISTM Abutment for NobelActive 3.0 is provided in three designs: ATLANTISTM Abutment for NobelActive, ATLANTIS™ Crown Abutment for NobelActive and ATLANTISTM Conus Abutment for NobelActive. All are patient specific fabricated abutments using CAD/CAM technology. Each abutment is designed according to prescription instructions from the clinician to support a screw-retained. cement-retained or friction fit prosthesis.
The coronal portion of the ATLANTIS™ abutment can be fabricated as a conventional abutment for prosthesis attachment (ATLANTIS™ Abutment or ATLANTISTM Conus Abutment) or fabricated as a single tooth final restoration onto which porcelain is added (ATLANTISTM Crown Abutment). The implant/abutment interface is compatible with the NobelActive 3.0 implant.
ATLANTISTM Abutment for NobelActive 3.0 has an internal connection and is provided for implant platform diameter Ø3.0 mm. The abutment diameter ranges from 3.3 to 13 mm, the maximum abutment height is 15 mm above implant interface and the minimum abutment height is 4 mm above the transmucosal collar. The abutment is provided straight and up to 30° of angulation.
Here's an analysis of the provided text regarding the acceptance criteria and study for the ATLANTIS™ Abutment for NobelActive 3.0.
Important Note: The provided document is a 510(k) premarket notification for a medical device (dental implant abutment). These types of submissions typically focus on demonstrating substantial equivalence to existing legally marketed devices, rather than establishing completely new performance criteria or conducting extensive effectiveness studies for a novel AI algorithm. Therefore, many of the requested categories related to AI performance, ground truth, and expert evaluation are not applicable to this type of traditional medical device submission.
The "studies" described are primarily non-clinical engineering tests to ensure mechanical integrity and compatibility with the predicate device.
Acceptance Criteria and Reported Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical Strength (ISO 14801): The ATLANTIS™ Abutment for NobelActive 3.0 must demonstrate sufficient strength for its intended use, as evaluated by static and dynamic compression-bending testing according to ISO 14801. | "Mechanical testing results show that the ATLANTISTM Abutment for NobelActive 3.0 has sufficient strength for its intended use." (Specific quantitative values are not provided in the summary, but the conclusion states sufficiency.) |
| Compatibility: The ATLANTIS™ Abutment for NobelActive 3.0 must be compatible with the NobelActive 3.0 implant. | "Compatibility analysis shows that the ATLANTIS™ Abutment for NobelActive 3.0 is compatible with the NobelActive 3.0 implant." |
| Biocompatibility: The device must be biocompatible. | "The results of biocompatibility testing conducted for the predicate devices... are valid, therefore, no additional biocompatibility testing has been performed." (Inherited from predicate devices). |
| Sterility: The device, if supplied sterile, must meet sterility requirements. | "The results from the previous sterility testing are valid for the proposed device... The sterility testing conducted for the predicate devices... was conducted with the same materials and same sterilization cycle." (Inherited from predicate devices). |
| Dimensional Analysis: The device must meet specified dimensional parameters. | Mentioned as performed: "dimensional analysis" (Specific details or limits are not provided in this summary). |
| Design Integrity: The mechanical design must be sound. | Mentioned as performed: "mechanical design analysis" (Specific details or limits are not provided in this summary). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated in the summary. For mechanical testing (ISO 14801), devices are typically tested in small batches to statistical significance or to demonstrate compliance with a specific load rating. The exact number of abutments tested is not provided.
- Data Provenance: The "Non-Clinical Performance Data" section (Section 7) describes testing performed by DENTSPLY International, Inc., the manufacturer/submitter, and references predicate devices. This would be considered prospective testing conducted specifically for this 510(k) submission or in support of prior predicate device approvals. The country of origin of the data is implied to be within the company's testing facilities, likely in the US as the submitter is a US company.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- N/A. This device is a physical medical device (dental abutment), not an AI algorithm that requires expert annotation for ground truth. The "ground truth" for its performance is established through quantitative mechanical testing and engineering analyses against defined standards (like ISO 14801).
4. Adjudication Method for the Test Set
- N/A. Adjudication methods (like 2+1, 3+1) are relevant for human evaluation processes, especially in clinical trials or AI performance evaluations involving multiple readers. This is a physical device undergoing mechanical and engineering tests, not an interpretive task.
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 is not an AI-powered diagnostic or assistive device. It is a physical dental implant abutment.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- N/A. This is a physical dental implant abutment, not an algorithm.
7. The Type of Ground Truth Used
- For Mechanical Strength & Compatibility: The "ground truth" is defined by engineering standards and specifications (e.g., ISO 14801, material properties, dimensional tolerances, fit with the corresponding implant). Performance is measured against these objective standards.
- For Biocompatibility & Sterility: The "ground truth" is derived from established regulatory standards and validated testing protocols (e.g., ISO 10993 for biocompatibility, ISO 11137 or AAMI standards for sterility assurance levels).
8. The Sample Size for the Training Set
- N/A. This is not an AI algorithm that requires a training set. The design of the ATLANTIS™ Abutment is based on CAD/CAM technology, but the "training" in this context refers to the manufacturing process, not machine learning.
9. How the Ground Truth for the Training Set was Established
- N/A. As there is no AI training set, this question is not applicable. The design and manufacturing process for the CAD/CAM abutment are governed by engineering principles and quality control, not ground truth derived from annotated data.
§ 872.3630 Endosseous dental implant abutment.
(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)