(206 days)
The Elos Accurate® Customized Abutments are intended for attaching to dental implants in order to provide basis for single or multiple tooth prosthetic restorations. The Elos Accurate® Customized Abutment will be attached to a dental implant using the included Elos Prosthetic screw.
The Elos Accurate® Customized Abutments are compatible with the implant systems listed in table 1:
Table 1.
| Elos Accurate Customized Abutment – Model Type | Platform compatibility | Platform diameter [mm] | Implant Body diameter [mm] |
|---|---|---|---|
| AB-ATO35 | Astra Tech 3.5/4.0 | 3.5 & 4 | 3.5 & 4 |
| AB-ATO45 | Astra Tech 4.5/5.0 | 4.5 & 5 | 4.5 & 5 |
| AB-ATE36 | Astra Tech EV 3.6 | 3.6 | 3.6 |
| AB-ATE42 | Astra Tech EV 4.2 | 4.2 | 3.6 & 4.2 |
| AB-ATE48 | Astra Tech EV 4.8 | 4.8 | 4.2 & 4.8 |
| AB-ATE54 | Astra Tech EV 5.4 | 5.4 | 5.4 |
All digitally designed CAD/CAM customizations for the Elos Accurate® Customized Abutments are only intended to be sent and manufactured at a FDA registered Elos Medtech approved milling facility.
The Elos Accurate® Customized Abutment is a patient specific abutment intended for attaching to dental implants in order to provide basis for single- or multiple tooth prosthetic restorations. The Elos Accurate® Customized Abutment will be attached to the implant using the included Elos Prosthetic Screw and attached to the crown/coping manually by cementation. The Elos Accurate® Customized Abutment consists of an Abutment Blank used in fabricating of a full patient-specific abutment in Titanium alloy per ASTM F136. The Abutment Blank used in creation of the Elos Accurate® Customized Abutment has a pre-manufactured connection interface that fits directly to a pre-specified dental implant. The customized shape of the abutment is intended to be manufactured by an Elos Medtech approved milling facility. The Elos Accurate® Customized Abutment is delivered nonsterile and the final restoration including corresponding Elos Prosthetic Screw is intended to be sterilized at the dental clinic before it is placed in the patient. The Elos Accurate® Customized Abutment provides clinicians and laboratories with a prosthetic device that can be used in definitive (permanent) single- or multi restorations.
The provided document, a 510(k) Premarket Notification summary for the Elos Accurate® Customized Abutment, outlines the device's indications for use, technological characteristics, and non-clinical testing conducted to demonstrate substantial equivalence to a predicate device. However, it does not contain information typically found in an acceptance criteria and performance study for a medical device that uses an algorithm or AI. This document is for a physical dental abutment, not a device that relies on an algorithm or AI for its function.
Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving device meets acceptance criteria related to an AI/algorithm-based device. The original document does not offer data points for:
- A table of acceptance criteria and reported device performance (in the context of algorithm performance)
- Sample size for a test set or data provenance
- Number of experts or their qualifications for ground truth
- Adjudication method
- MRMC comparative effectiveness study
- Standalone algorithm performance
- Type of ground truth (e.g., pathology, outcomes data)
- Sample size for a training set
- How ground truth for a training set was established
The "testing" mentioned in the document (fatigue testing, biocompatibility testing, dimensional analysis) is for the physical material and design of the abutment, not for an algorithm's performance.
§ 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.)