(175 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 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-retained by friction fit to the abutment screw is intended to secure the ATLANTIS Conus Abutment to the endosseous implant.
ATLANTISTM products are compatible with the implants shown in the table below.
Implant Manufacturer - HIOSSEN INC
Trade Name Abutment Platform Diameter HIOSSEN ET III SA Fixture Mini 03.5mm HIOSSEN ET III SA Fixture Regular 04.0, 4.5, 5.0, 6.0, 7.0 mm
Implant Diameter 03,5mm Ø4.0. 4.5. 5.0. 6.0. 7.0 mm
The proposed ATLANTIS™ Abutment for HIOSSEN ET implant is an endosseous dental implant abutment. The subject device is provided for implant diameter (03.5, 4.0, 4.5, 5.0. 6.0 and 7.0 mm) and three designs: ATLANTIS™ Abutment for HIOSSEN ET implant, ATLANTIS™ Crown Abutment for HIOSSEN ET implant and ATLANTIS™ Conus Abutment for HIOSSEN ET implant, see table 5-1. All are patient-specific abutments fabricated using CAD/CAM technology at DENTSPLY Implant 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 HIOSSEN ET implants from the HIOSSEN Implant System (K140934).
The HIOSSEN ET implant interface is a slight conical (11°) internal hex connection and provided for implant platform diameter Mini (3.5 mm), and Regular (4.0, 4.5, 5.0, 6.0 and 7.0 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.
The provided text describes a 510(k) premarket notification for the ATLANTIS™ Abutment for HIOSSEN ET implant, a dental implant abutment. It is a submission to demonstrate substantial equivalence to legally marketed predicate devices, rather than a study designed to meet specific performance criteria for a novel AI device. Therefore, much of the requested information regarding acceptance criteria, performance metrics, sample sizes for test/training sets, expert involvement, and ground truth establishment is not directly applicable in the typical sense for AI/ML medical devices.
However, I can extract information related to the device's characteristics, testing performed to establish substantial equivalence, and general "performance" in terms of its mechanical properties and compatibility.
Here's a breakdown of the relevant information:
1. A table of acceptance criteria and the reported device performance
The submission does not explicitly define "acceptance criteria" in the way one would for an AI model's sensitivity, specificity, or accuracy. Instead, it relies on demonstrating that the proposed device is mechanically safe and compatible, comparable to existing predicate devices.
| Feature/Test | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Material composition similar to predicate devices with established biocompatibility. (Implied: No adverse biological reactions) | "The results of biocompatibility testing conducted for the predicate device, OsseoSpeed Profile EV (K130999), are valid because the material composition of the proposed device is similar to the ATLANTIS™ Abutments covered by the predicate device, OsseoSpeed Profile EV (K130999). Therefore, no additional biocompatibility testing has been conducted." |
| Sterility | Same materials and sterilization cycle as predicate devices with established sterility. (Implied: Device is sterile) | "The sterility testing conducted for the predicate device, OsseoSpeed Profile EV (K130999), was conducted with the same materials and same sterilization cycle. Therefore, no additional sterility testing was required for the proposed device, ATLANTIS™ Abutment for HIOSSEN ET implant." |
| Mechanical Strength | Meets standards for dental implants (e.g., ISO 14801) for intended use. (Implied: Withstands static and dynamic forces in the oral cavity) | "Non-clinical testing data submitted, referenced, or relied upon to demonstrate substantial equivalence includes mechanical design analysis, dimensional analysis, and static and dynamic compression-bending testing according to ISO 14801 Dental-implants Dynamic Fatigue Test for Endosseous Dental Implants." "Mechanical testing results show that the ATLANTIS™ Abutment for HIOSSEN ET implant has sufficient strength for its intended use." |
| Compatibility | Compatible with specified implant diameters (3.5, 4.0, 4.5, 5.0, 6.0, 7.0 mm) from HIOSSEN ET implants. (Implied: Physically fits and functions with the specified implants) | "Compatibility analysis shows that the ATLANTIS™ Abutment for HIOSSEN ET implant is compatible with the Mini (3.5 mm) and Regular (4.0, 4.5, 5.0, 6.0 and 7.0 mm) HIOSSEN ET implants." Furthermore, the tables detail compatibility with HIOSSEN ET implant interfaces for different abutment types (Titanium, Zirconia, Gold-shaded titanium) and sizes. |
| Indications for Use (Similarity) | Proposed indications are similar to predicate devices. (Implied: Device is suitable for similar clinical applications as already marketed devices) | The document explicitly compares the proposed device's indications for use with two predicate devices (OsseoSpeed Profile EV and HIOSSEN Implant System). It states, "The indications for use of the proposed device are similar to the indications for use of the primary predicate device." And "The indications for use are similar. The difference... is that the prosthesis, in addition to screw-retained restoration or cement retained restoration, can be attachment-retained (by friction fit) to the proposed device." The document aims to demonstrate that any differences do not raise new questions of safety or effectiveness. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This submission does not detail "test sets" in the context of clinical data for an AI/ML device. The non-clinical performance data refers to mechanical and dimensional testing of the abutments themselves.
- Sample Size: Not specified for mechanical testing beyond "test data." For biocompatibility and sterility, no new samples were tested; reliance was placed on predicate device data.
- Data Provenance: The testing was non-clinical (mechanical, dimensional), likely performed in a lab setting by the manufacturer, Dentsply Sirona. The document does not specify a country of origin for this testing or whether it was retrospective or prospective, as these terms are typically applied to patient data.
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)
This information is not applicable. The device is a physical medical device (dental implant abutment), not an AI/ML algorithm requiring expert-labeled ground truth for diagnostic or prognostic purposes. The performance assessment relates to engineering specifications and material properties, not interpretations by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable for the same reasons as point 3.
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
This information is not applicable as the device is a physical dental abutment, not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable. The device is a physical abutment, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" here is based on:
- Engineering Standards: Compliance with ISO 14801 for mechanical properties.
- Material Science: Properties of titanium alloy and zirconia.
- Dimensional Specifications: Precise fit with the specified HIOSSEN ET implants.
- Predicate Device Data: Historical safety and effectiveness data from previously cleared similar devices (K130999 and K140934) regarding biocompatibility, sterility, and performance.
8. The sample size for the training set
This information is not applicable as the device is a physical medical device, not an AI/ML algorithm that is "trained."
9. How the ground truth for the training set was established
This information is not applicable as the device is a physical medical device, not an AI/ML algorithm.
§ 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.)