(217 days)
OsseoSpeed™ Angled Abutment EV is intended to be used in conjunction with Astra Tech Implant System EV in fully edentulous or partially edentulous maxillary and/or mandibular arches to provide support for bridges or overdentures.
The AtlantisTM 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 prostheses, 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.
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.
Atlantis™ Abutment and Atlantis™ Crown Abutment are compatible with Ø5.4 Astra Tech Implant System EV.
OsseoSpeed Angled Abutment EV is designed for multi-unit, screw-retained restorations in a partially or fully edentulous situation. It is provided in three platform diameters (3,6, 4,2 and 4.8 mm) and two angles (20° and 30°). It is intended to fit Astra Tech implants of corresponding diameters cleared under K111287 and K120414. All abutments with a 20°angle are provided in two gingival heights (1.0 and 2.0 mm) with an indexed interface. All abutments with a 30°angle have a non-indexed interface and are provided in two gingival heights (1.0 and 3.0 mm).
OsseoSpeed Angled Abutment EV is not compatible with Astra Tech 3.0 mm diameter implants.
Atlantis Abutment in Zirconia for OsseoSpeed EV is a custom abutment for prosthesis attachment. Atlantis Crown Abutment in Zirconia for OsseoSpeed EV is fabricated as a custom single-tooth final restoration and is shaped in the design of the final prosthesis onto which porcelain is added. Both Atlantis abutments are provided in a platform diameter of 5,4 mm.
The provided text is a 510(k) summary for a medical device (dental abutments) and does not contain information about acceptance criteria or a study proving that the device meets those criteria in the way typically required for AI/ML-based diagnostic devices.
The document discusses the substantial equivalence of the new device to existing predicate devices based on its intended use, design principles, materials, and manufacturing processes. It briefly mentions "Testing of OsseoSpeed™ Angled Abutment EV according to ISO 14801 Dentistry - Implants -Dynamic fatigue test for endosseous dental implants, was performed and the results show that OsseoSpeed™ Angled Abutment EV has sufficient mechanical strength for the intended clinical application and demonstrate that it is substantially equivalent to the listed predicate devices."
However, this is a mechanical fatigue test, not a clinical performance study with expert ground truth, multi-reader multi-case analysis, or standalone algorithm performance, as would be relevant for an AI/ML device. Therefore, most of the requested fields cannot be filled from the provided text.
Here is an attempt to address the request based on the available information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical Strength (ISO 14801 Dynamic Fatigue Test for Endosseous Dental Implants) | "sufficient mechanical strength for the intended clinical application" and "demonstrate that it is substantially equivalent to the listed predicate devices." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified for the ISO 14801 test.
- Data Provenance: Not specified, but likely from laboratory testing (in vitro) based on the test type.
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. The ground truth for a mechanical fatigue test is typically defined by the physical properties and performance characteristics measured according to the standard, not by expert interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This concept pertains to human review of diagnostic results, not mechanical testing.
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
No. This document does not mention an MRMC study or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. This document does not describe an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the mechanical test, the ground truth is based on the physical properties and performance characteristics as defined and measured by the ISO 14801 standard.
8. The sample size for the training set
Not applicable. This device is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This device is not an AI/ML algorithm that requires a training set.
§ 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.)