(128 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 mandible or maxilla. The prosthesis can be cemented or screw retained to 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 attachment. The abutment. The abutment. The abutment screw is intended to secure the ATLANTIS® Conus Abutment to the endosseous implant.
ATLANTIS® Abutment for MIS implant is compatible with MIS implant System. MIS short implants (6mm) are to be used only with straight abutments.
ATLANTIS® products are compatible with the implants shown in the table below.
| Implant manufacturer | MIS-IMPLANT TECHNOLOGIES INC |
|---|---|
| ---------------------- | ------------------------------ |
| Trade Name | Abutment Platform Diameter | Implant Diameter |
|---|---|---|
| MIS Implant M4 & SEVEN Narrow Platform | Ø3.30 mm | Ø3.30 mm |
| MIS Implant M4 & SEVEN Standard Platform | Ø3.75 and 4.2 mm | Ø3.75 and 4.2 mm |
| MIS Implant M4 & SEVEN Wide Platform | Ø5.0 and 6.0 mm | Ø5.0 and 6.0 mm |
The proposed ATLANTIS® Abutment for MIS Implant is an endosseous dental implant abutment. The subject device is provided for implant diameter (Ø3.3, 3.75, 4.2, 5.0 and 6.0 mm) and three designs: ATLANTIS® Abutment for MIS Implant, ATLANTIS® Crown Abutment for MIS Implant and ATLANTIS® Conus Abutment for MIS Implant, see table 5-1. All are patient-specific abutments fabricated using CAD/CAM technology at Dentsply Implant manufacturing sites. 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 ATLANTIS® Conus Abutment) or fabricated as a single tooth final restoration onto which porcelain is added (ATLANTIS® Crown Abutment). The ATLANTIS® abutment interface is compatible with the MIS implants from the MIS Implant System (K040807) and MIS implants from MIS Short Implants (K103089).
The MIS M4 & SEVEN implant interface has an internal hex connection and provided for implant platform diameter Narrow (3.30 mm), Standard (3.75 and 4.20 mm) and Wide (5.0 and 6.0 mm). The abutment height 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 trans-mucosal collar. The abutment is provided straight and up to 30° of angulation.
The provided text is a 510(k) Pre-Market Notification for the ATLANTIS® Abutment for MIS Implant. It does not describe an AI/ML powered medical device, but rather a dental implant abutment which is a physical device. Therefore, the questions related to AI/ML device acceptance criteria and study design are not applicable.
However, I can provide the acceptance criteria and the study that proves the physical device meets its acceptance criteria based on the information provided in the document.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance (Study Results) |
|---|---|
| Static and dynamic compression-bending capabilities according to ISO 14801: Dental-implants Dynamic Fatigue Test for Endosseous Dental Implants. | Successful. The non-clinical test data and analyses for static and dynamic compression-bending testing were "included to support substantial equivalence." (Exact numerical performance data is not explicitly quantified in this summary, but the conclusion states that "Test data to verify the performance... has been provided with mechanical testing" and supports substantial equivalence.) |
| Dimensional compatibility with specified MIS Implant Technologies, Inc. implant platforms (Narrow (Ø3.30 mm), Standard (Ø3.75 and 4.2 mm), and Wide (Ø5.0 and 6.0 mm), M4 and SEVEN implant platforms). | Successful. "Geometric analyses conducted on implant bodies, abutments, and screws to support the dimensional compatibility" were performed and the "dimensional compatibility analyses... support substantial equivalence." |
| Sterilization parameters validated according to ISO 17665-1 (Moist heat) and ISO 20857 (Dry heat). | Successful. "Sterilization parameters which have been validated according to ISO 17665-1... and ISO 20857... are included and are as referenced in the predicate device (K160626)." |
| Biocompatibility (implied criterion by material composition and manufacturing process). | Successful. "The material composition and manufacturing processing methods of the subject ATLANTIS® Abutment for MIS Implant are identical to the predicate device, ATLANTIS® Abutment for Hiossen ET Implant (K160626). Therefore, no additional biocompatibility data is included to support substantial equivalence." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the sample sizes used for the mechanical testing or geometric analyses. It also does not specify the country of origin or whether the data was retrospective or prospective. These details are typically found in the full test reports referenced in the 510(k) submission, not in the summary document.
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. This is a physical device, not an AI/ML device that requires expert ground truth for image interpretation or diagnosis. The "ground truth" for this device would be established by engineering specifications, materials science standards, and established regulatory test methodologies.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is a physical device, not an AI/ML device that requires expert adjudication for diagnostic outputs. The performance is assessed through standardized engineering tests.
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 device, not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a physical device, not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this medical device would be defined by engineering standards, material properties, and regulatory performance requirements. For example:
- Mechanical Testing: Ground truth is defined by the requirements of ISO 14801, which sets pass/fail criteria for fatigue strength, and by the established strength and durability of the predicate device.
- Dimensional Compatibility: Ground truth is defined by the precise geometric specifications and tolerances of the MIS implant interface, ensuring a proper fit.
- Sterilization: Ground truth is defined by the validation criteria outlined in ISO 17665-1 and ISO 20857, ensuring a sterile product.
- Biocompatibility: Ground truth is established by the accepted biocompatibility of the identical materials used in the predicate device.
8. The sample size for the training set
Not applicable. This is a physical device, not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is a physical device, not an AI/ML device.
§ 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.)