(43 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 cement 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 and zirconia abutments are compatible with the Nobel Biocare's NobelActive Implants: NP 3.3mm, RP 4.3mm and 5.0 mm sizes
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 (i.e. 30 degrees) on implants with diameters less than 4 mm are intended for the anterior region of the mouth and are not intended for the posterior region due to limited strength of the implant.
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 restorations. The Atlantis™ Abutment for Nobel Biocare Active Implant and abutment screw are made from Titanium grade Ti-6A1-4V ELI (meets ASTM Standard F-136) for the 3.5mm, 4.3mm and 5.0mm sizes. In addition, the Atlantis™ Abutment for Nobel Biocare Active Implant for the 3.5mm, 4.3mm and 5.0mm sizes, also are made of the biocompatible material, yttria-stabilized tetragonal zirconia polycrystals (Y-TZP) (meets ISO Standards 6072 & 13356). Zirconia may have a variation in shade. The titanium and the zirconium abutments are placed over the implant shoulder and are mounted into the implant with a titanium screw.
The provided text is a 510(k) premarket notification for a dental abutment. The primary purpose of this type of submission is to demonstrate substantial equivalence to a legally marketed predicate device, rather than to establish safety and effectiveness through clinical trials with detailed acceptance criteria and performance studies for a novel device.
Therefore, the document does not contain the kind of detailed information requested in your prompt regarding acceptance criteria, specific device performance metrics, sample sizes for test sets, expert ground truth establishment, or clinical study designs (like MRMC or standalone performance). The "study" proving the device meets acceptance criteria is fundamentally a demonstration of equivalence to the predicate, primarily through material and design specifications and intended use.
Here's an analysis based on the information provided, explaining why certain sections of your request cannot be fulfilled:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: Not explicitly stated in terms of quantitative performance metrics for the device itself (e.g., specific force resistance values, wear rates, etc.). The "acceptance criteria" for this submission are fundamentally demonstrating that the Atlantis™ Abutment for Nobel Active Implant has the same intended use, material, and design characteristics as the predicate devices, and performs similarly in terms of its intended function as an endosseous dental implant abutment.
- Reported Device Performance: No specific quantitative performance data (e.g., stress testing results, fatigue life in cycles) is reported in this summary. The performance is implied to be "substantially equivalent" to the predicate.
| Acceptance Criteria (Implied) | Reported Device Performance (Implied) |
|---|---|
| Intended Use matches predicate | The Atlantis™ Abutment is intended for use with an endosseous implant to support a prosthetic device in a partially or completely edentulous patient, supporting single and multiple tooth prosthesis, in the mandible or maxilla. This aligns with the general intended use of endosseous dental implant abutments. |
| Material composition matches predicate or is well-established | Abutments and screws are made from Titanium grade Ti-6A1-4V ELI (meets ASTM Standard F-136) and/or yttria-stabilized tetragonal zirconia polycrystals (Y-TZP) (meets ISO Standards 6072 & 13356). These are standard, biocompatible materials used in dental implants. |
| Design principles and compatibility match predicate | The abutments are designed to be placed into the dental implant to provide support for a prosthetic restoration (cemented or screw-retained). They are compatible with Nobel Biocare's NobelActive Implants (NP 3.3mm, RP 4.3mm and 5.0 mm sizes). The design provides similar functionality to the predicate abutments. |
| Performance (e.g., strength, durability) is substantially equivalent to predicate | Not explicitly quantified or reported, but implied by the assessment of substantial equivalence in materials and design. The general note about highly angled abutments for anterior regions suggests consideration of strength relevant to different anatomical locations. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not applicable in the context of this 510(k) summary. This document does not describe a clinical performance study with a "test set" of patients or images. Instead, it relies on demonstrating substantial equivalence to pre-existing, legally marketed devices.
- Data Provenance: Not applicable. There is no patient data (retrospective or prospective) described in this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. There is no "test set" requiring expert ground truth in this type of submission.
4. Adjudication method for the test set:
- Not applicable. There is no patient-level or image-level test set that would require adjudication.
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 medical device for tooth restoration, 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:
- Not applicable. This is a physical medical device (an abutment), not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable. The "ground truth" for this submission is the established safety and effectiveness of the predicate devices, based on their prior marketing clearance and use. The new device demonstrates conformance to established engineering specifications and biocompatibility standards rather than clinical ground truth from patient outcomes.
8. The sample size for the training set:
- Not applicable. This is not an AI/machine learning device.
9. How the ground truth for the training set was established:
- Not applicable. This is not an AI/machine learning device.
In summary: K093483 is a 510(k) premarket notification for a dental abutment. The "study" demonstrating that it meets "acceptance criteria" is the comprehensive technical and regulatory documentation showing its substantial equivalence to previously cleared predicate devices (K071370 and K072129) in terms of intended use, materials, and design. It is not a clinical trial with performance metrics typically associated with novel or AI-driven diagnostic devices.
§ 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.)