(98 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 abutment to the endosseous implant.
This device is compatible with the following manufacturers' implant systems:
The titanium abutments are compatible with the Camlog 3.3mm, 4.3mm, 5.0mm and 6.0mm Root-Line, Cylinder-Line, Cylinder Line TPS, Screw-Line, Promote and Promote Plus K-Series Implants.
The zirconia abutments are compatible with the Camlog 3.8mm. 5.0mm and 6.0mm Root-Line, Cylinder-Line, Cylinder Line TPS, Screw-Line, Promote and Promote Plus K-Series 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 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 indicated for cemented or screw retained restorations. The Atlantis™ Abutment for Camlog Implant and abutment screw are made of Titanium grade Ti-6A1-4V ELI (meets ASTM Standard F-136) for the 3.3mm. 3.8mm. 4.3mm. 5.0mm and 6.0mm sizes. In addition. the Atlantis™ Abutment for Camlog Implant for the 3.8mm. 4.3mm. 5.0mm and 6.0mm sizes are also made of biocompatible material, yttria-stabilized 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.
Here's a breakdown of the acceptance criteria and study information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
Acceptance Criteria:
The document implicitly defines acceptance criteria through the successful performance of "worst case scenario" implant assemblies under static and fatigue compression testing. The overarching acceptance criterion is that the implant system (Atlantis Abutments with Camlog implants) must perform as intended under these loads. "As intended" implies demonstrating mechanical integrity and stability comparable to or better than the predicate devices.
Reported Device Performance:
| Test Type | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Static Compression Testing | Must withstand appropriate static test loads. Demonstrate mechanical integrity. | Test results demonstrated that the implant system supported appropriate static test loads. |
| Fatigue Compression Testing | Must withstand appropriate fatigue test loads. Maintain structural integrity over time. | Test results demonstrated that the implant system supported appropriate fatigue test loads. |
| Compatibility | Must be compatible with Camlog implants. | Test results demonstrated that the Atlantis Abutments are compatible with the Camlog implants. |
| Overall Performance | Must perform as intended in supporting a prosthetic device under various loading conditions. | Test results demonstrated that the implant system performs as intended (implying it meets the functional and structural requirements for supporting prosthetic devices in an oral environment). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not explicitly state the exact number of samples (implant assemblies) used for static and fatigue compression testing. It refers to "worst case scenario" implant assemblies without specifying the quantity.
- Data Provenance: This was a non-clinical bench testing study, not involving human subjects. Therefore, data provenance in terms of country of origin or retrospective/prospective human data is not applicable. The tests were conducted to evaluate the mechanical performance of the device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not Applicable. This was a non-clinical bench testing study assessing mechanical performance against engineering standards and established methods for dental implant testing (static and fatigue compression). Ground truth was established through validated testing protocols and measurements, not expert human assessment.
4. Adjudication Method
- Not Applicable. As this was a non-clinical bench testing study, there was no need for human adjudication of results. The outcomes are objective measurements of mechanical load bearing and fatigue resistance.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No. An MRMC comparative effectiveness study is designed for evaluating human reader performance with and without AI assistance, typically in image interpretation or diagnostic tasks. This submission is for a dental implant abutment, and the testing involved mechanical performance, not diagnostic review.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done
- Yes, in essence. The testing described is a "standalone" evaluation of the device's mechanical performance in a laboratory setting. The "device" here is the Atlantis™ Abutment and its interaction with the Camlog implant system. The performance evaluated (static and fatigue strength) is inherent to the device itself, without human intervention during the actual performance measurement. There is no "algorithm" in the context of an AI device.
7. The Type of Ground Truth Used
- Engineering Standards and Bench Test Results: The "ground truth" for this device's performance is established by its ability to meet accepted industry standards for static and fatigue strength of dental implant components. The test results (load sustained, cycles to failure) serve as the objective ground truth, demonstrating the device's mechanical properties. It's not pathology, expert consensus, or outcomes data in the biological sense, but rather a mechanical performance assessment.
8. The Sample Size for the Training Set
- Not Applicable. This device is a physical medical device (dental implant abutment), not an AI/machine learning algorithm. Therefore, there is no "training set" in the context of algorithm development.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As there is no training set for an algorithm, this question is not relevant to this device's submission.
§ 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.)