(115 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-NBR43 | Nobel Replace RP | 4.3 | 4.3 |
| AB-NBR50 | Nobel Replace WP | 5 | 5 |
| AB-NBR60 | Nobel Replace 6.0 | 6 | 6 |
| AB-NBA35 | Nobel CC NP | 3.5 | 3.5 & 3.75 |
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 text describes a medical device, the Elos Accurate® Customized Abutment, and its 510(k) submission to the FDA. However, the document does not contain information regarding objective acceptance criteria (e.g., performance metrics with defined thresholds), nor does it detail a study that proves the device meets such criteria.
Instead, the document focuses on demonstrating substantial equivalence to a previously cleared predicate device (K190299) based on similar intended use, operating principle, design, materials, and sterilization processes.
Therefore, I cannot provide a table of acceptance criteria and reported device performance or information about sample sizes for test sets, expert adjudication methods, MRMC studies, standalone performance, or ground truth details, as these are not present in the provided text.
The information that is available regarding testing is non-clinical and aims to show similarity and safety compared to the predicate device, rather than meeting specific performance thresholds against a defined clinical outcome.
Here's a summary of the non-clinical testing performed, which serves as the evidence for substantial equivalence:
Non-Clinical Testing Information (as provided):
- Type of Testing:
- Engineering and dimensional analysis of original manufacturers' components (abutments, implants & abutment screws) for determination of compatibility.
- Fatigue testing per ISO 14801 according to FDA guidance for Industry and FDA Staff "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments" dated May 12, 2004.
- Biocompatibility testing for cytotoxicity according to ISO 10993-5.
- Tests Included for Biocompatibility:
- Non-coated prosthetic screw (representative for subject device, tested on primary predicate device K190299).
- Medicarb coated prosthetic screw (representative for subject device, tested on reference predicate device K171799).
- Elos Accurate® Customized Abutment (representative for subject devices, tested on reference predicate device K171799).
- Sterilization: The primary predicate device was tested according to ISO 17665-1 & ISO 17665-2, demonstrating a Sterility Assurance Level (SAL) of $10^{-6}$. No additional testing was deemed necessary for the subject device.
Missing Information (Not provided in the document):
- Specific quantitative acceptance criteria for performance metrics.
- A clinical study designed to demonstrate performance against such criteria.
- Sample size used for a test set (as no such test set for performance evaluation is described).
- Data provenance for a test set.
- Number of experts used to establish ground truth or their qualifications.
- Adjudication method for a test set.
- Multi-reader multi-case (MRMC) comparative effectiveness study results.
- Effect size of human reader improvement with AI vs. without AI assistance.
- Standalone (algorithm-only) performance.
- Type of ground truth used (expert consensus, pathology, outcomes data, etc.).
- Sample size for the training set.
- How ground truth for the training set was established.
The document's purpose is to establish substantial equivalence for regulatory clearance, not to report on a clinical performance study with predefined acceptance criteria.
§ 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.)