(280 days)
ArgenIS Titanium Abutments are intended to be single use available by prescription only in the construction of dental restorations supported by the endosseous dental implant. The Argents Titanium Abutments are designed to specifically fit an individual patient's needs of the final restoration. All digitally designed abutments files are intended to be sent to Argen manufacturer for milling.
The ArgenIS Titanium Abutments are compatible with the following implant systems:
| Implant Brand Name | Platform | Manufacturer | Implant Trade Name | Implant
Line/Connection | Implant Diameter |
|------------------------------------|---------------|------------------|------------------------------------|----------------------------|------------------------------------------------|
| Hiossen ET III SA | 3.5mm | Hiossen | Hiossen Implant System | Internal Hex | 3.75, 3.77mm |
| Hiossen ET III SA | 4.0/4.5/5.0mm | Hiossen | Hiossen Implant System | Internal Hex | 4.25, 4.65, 4.63,
4.6, 5.1, 5.08,
5.05mm |
| Nobel Active Wide
Platform (WP) | 5.5mm | Nobel Biocare AB | Nobel Active Wide
Platform (WP) | Internal Hex | 5.5mm |
The ArgenIS Titanium Abutments are designed specifically for an individual patient and then milled from a titanium blank with a pre-milled interface correlating to a specific implant system. The titanium abutment may be designed with a maximum angulation of 30°. The abutment is then fixed with the use of a lab screw to a model containing the implant analog for final construction of the related prosthetic restoration. The ArgenIS Titanium Abutments are then intended to be fixed in the mouth with the prosthetic final screw. The ArgenIS Titanium Abutments are supplied with two package configurations. One includes two final screws and the abutment and another includes one final screw and one lab screw and the abutment. The final screw is used for fixing abutment to the endosseous implant body, and the lab screw is used for laboratory use during construction of related restoration to avoid any damage to the final prosthetic screw. The final prosthetic screw will be marked "final Screw". The final screw must be torqued on the endosseous implant body with the specific torque setting provided. The device is finalized at the Argen facility and provided to the dental laboratory in a final patient specific form. There are no accessories associated with the subject devices.
Minimum and Maximum Gingival Height is 0.5mm - 6mm Minimum diameter at abutment/implant interface is 3.5mm to interface base Maximum length of abutment from abutment/implant interface is 12.5mm Minimum length of abutment post (length above abutment collar/gingival height) is 4.0mm Minimum wall thickness at abutment/implant interface is 0.65mm Maximal angle in relationship to the long axis of implant is 30°
All digitally designed abutment files are intended to be sent to Argen manufacturer for milling. Argen is a registered contract manufacturer with a quality system under FDA QSR regulation.
The document primarily focuses on establishing "substantial equivalence" of the ArgenIS Titanium Abutments to legally marketed predicate devices, rather than defining specific acceptance criteria for a new device and proving its performance against those criteria in a typical clinical study.
However, based on the non-clinical performance testing summarized in section 14 and the comparison table in section 13, we can infer some "acceptance criteria" related to the device's physical and mechanical properties, and how it was evaluated.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Inferred from testing) | Reported Device Performance (Summary) |
|---|---|
| Mechanical Strength/Fatigue Life: The device must withstand fatigue forces representative of oral use. | "Fatigue testing was performed on worst case scenario samples in accordance with the Class II Special Controls Guidance Document and ISO 14801. Performance testing demonstrated conformance to design input and indications for use." |
| Dimensional Accuracy/Compatibility: The abutments must accurately fit specified implant systems. | "Non-Clinical testing consisted of reverse engineering of the OEM implant body, abutment and abutment screw and tolerance analysis of platforms to ensure implant/abutment compatibility, dimensional verification and implant/abutment connection checks." |
| Sterility Assurance Level (SAL): The sterilization process must achieve an SAL of 10^-6. | "Moist Heat sterilization validation testing was performed in accordance with ANSI/AAMI/ISO 17665-1: 2006 and ISO ANSI/AAMI/ISO 17665-2: 2009. Test results demonstrate a sterility assurance level of 10-6." |
| Biocompatibility: The materials must be biocompatible. | "The Argen IS Titanium Abutments have the same sterilization process and biocompatibility as previously cleared Argen and Sterngold devices. Therefore sterility and bio-compatibility testing performed on cleared Argen devices is applicable to the proposed devices." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: The document does not specify exact sample sizes for the fatigue or dimensional testing. It mentions "worst case scenario samples" for fatigue testing.
- Data Provenance: The data is from non-clinical testing (laboratory testing) and not a clinical study involving human subjects. Therefore, "country of origin of data" or "retrospective/prospective" are not applicable in the typical sense of a human clinical trial. This is manufacturer-led testing.
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 question is not applicable. The evaluations described are technical and engineering-based (fatigue, dimensional analysis, sterilization validation), not subjective assessments requiring expert interpretation of clinical data or images to establish a "ground truth."
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This question is not applicable as the testing involves objective measurements against engineering standards and material properties, not subjective assessments requiring 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
- No MRMC or human-in-the-loop study was conducted. This device is a dental implant abutment, a physical component, and does not involve AI or human "readers" in the context of interpretation of data.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No standalone (algorithm only) performance study was done as this is a physical medical device, not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for the non-clinical testing was based on engineering standards and specifications (e.g., ISO 14801 for fatigue testing, ANSI/AAMI/ISO 17665-1/2 for sterilization), and the design input/specifications for the abutment and its compatibility with implant systems. For biocompatibility, it relied on the "ground truth" established for previously cleared Argen and Sterngold devices with similar materials.
8. The sample size for the training set
- This question is not applicable. There is no software algorithm or AI model being "trained" for this physical device.
9. How the ground truth for the training set was established
- This question is not applicable as there is no training set for this physical device.
§ 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.)