(153 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, 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.
| Acceptance Criterion (Implicit for Substantial Equivalence Determination) | Reported Device Performance |
|---|---|
| Material Composition Equivalence | Zirconia (Y-TZP) and Titanium (Ti-6A1-4V ELI) for new device; comparable to Titanium (Ti-6A-4V ELI) for predicate. Both meet relevant ISO/ASTM standards. |
| Performance Characteristics Equivalence | Allows prosthesis to be cemented/screw-retained; abutment screw secures abutment to implant. Similar to predicate. |
| Intended Use Equivalence | Same intended use: support prosthetic device, single/multiple tooth prosthesis in mandible/maxilla, compatible with Dentsply Ankylos implants. Similar to predicate. |
| Device Description & Clinical Use Equivalence | Compatible with Dentsply Ankylos implant sizes (3.5mm-7.0mm); may be used in early load situations; highly angulated abutments for anterior region. Similar to predicate. |
| Dimensions & Angulation Equivalence | Abutment sizes: 3.5mm, 4.5mm, 5.5mm, 7.0mm. Geometry limits: angles up to 30 degrees, widths up to 6.5mm, heights up to 15mm. Similar to predicate. |
| Mechanical Performance (Non-clinical Testing) | "Static and fatigue compression testing was conducted on 'worst case scenario' implant assemblies... Test results demonstrated that the Atlantis Abutments and Atlantis Crown Abutments are compatible with the Dentsply Ankylos Implant and the implant system supported appropriate static and fatigue test loads demonstrating that the implant system performs as intended." |
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.
§ 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.)