(328 days)
ArgenIS patient specific abutments are intended to be single use available by prescription only to dental professionals (dental technicians and Dentists) in the construction of dental restorations supported by endosseous dental implants. The Argen Is Abutment is designed to specifically fit an individual patients needs in order to more naturally support the tissue, esthetics, and function of the final restoration.
The ArgenIS Titanium Abutments are compatible with the following implant systems:
| Implant Brand and Type | Implant Diameter | |||
|---|---|---|---|---|
| Nobel Biocare Replace Select | 3.5mm | |||
| Nobel Biocare Replace Select | 4.3mm | |||
| Nobel Biocare Replace Select | 5.0mm | |||
| Biomet 3i Certain | 3.25mm | |||
| Biomet 3i Certain | 4.0mm | |||
| Biomet 3i Certain | 5.0mm | |||
| Straumann Tissue Level - RN | 3.3mm | |||
| Straumann Tissue Level - RN | 4.1mm | |||
| Straumann Tissue Level - RN | 4.8mm | |||
| Zimmer Tapered Screw-Vent | 3.7mm | |||
| Zimmer Tapered Screw-Vent | 4.1mm | |||
| Zimmer Tapered Screw-Vent | 4.7mm | |||
| Zimmer Tapered Screw-Vent | 6.0mm |
Argen IS 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. This abutment can be fixed in the laboratory model work containing the implant analog for final construction of the related prosthetic restoration. The Argen IS Abutment is then intended to be fixed in the mouth with the included prosthetic screw. The Argen IS Abutment is supplied with 2 screws (1) A Final Screw for fixing to the endosseuos Implant. (2) A lab screw 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 endosseuos Implant 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.
Minimum and Maximum Gingival Height is 0-6mm 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 the 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°
The proposed ArgenIS Titanium Abutments are available in a range of diameters and connection type.
The provided document is a 510(k) premarket notification for the ArgenIS Titanium Abutments. This type of FDA submission is primarily focused on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through a standalone clinical study or by presenting detailed performance metrics against predefined benchmarks.
Therefore, the document does not contain the specific information requested in your prompt regarding acceptance criteria, a study proving device performance against those criteria, or a detailed breakdown of test sets, ground truth establishment, or clinical study types (MRMC, standalone).
However, I can extract the information that is present and explain why other details are not available in this type of document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of "acceptance criteria" with numerical targets and direct "reported device performance" values for clinical outcomes. Instead, it relies on bench testing to show functionality and equivalence to predicate devices. The "performance data" section focuses on demonstrating mechanical integrity and compatibility.
| Acceptance Criteria Category | Reported Device Performance (as described) |
|---|---|
| Functional Compatibility | - Tolerance analysis ensured abutment/implant interface compatibility. |
| - Functional fit checks of abutment blank to compatible implant, analog, and prosthetic screw showed correct functionality, including dimensional compatibility. | |
| Mechanical Performance / Fatigue | - Fatigue testing was conducted on "worst case scenario samples" (smallest diameter and shortest length from each platform) according to ISO 14801. (Specific results/metrics are not provided, only that it was conducted and supports substantial equivalence.) |
| Biocompatibility & Sterilization | - Argen IS Abutments have the "same sterilization process and parameters, and biocompatibility as previously cleared Sterngold devices." This implies adherence to established standards, but no specific test results are provided here. |
| Substantial Equivalence (Overall) | - Non-clinical test data (tolerance analysis, dimensional verification, implant mating checks) supports the claim of substantial equivalence to predicate devices based on FDA guidance "Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments." |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "worst case scenario samples" for fatigue testing (one implant size from each proposed platform) but does not provide a specific numerical sample size for this or other bench tests. It refers to "non-clinical test data," indicating these are laboratory-based tests, not human subject data. Therefore, data provenance in terms of country of origin or retrospective/prospective is not applicable as this is not a clinical study.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
This information is not applicable. The "ground truth" for the non-clinical bench testing would be established by engineering specifications, material standards, and regulatory requirements (e.g., ISO 14801). There is no mention of human experts establishing a "ground truth" in the diagnostic or clinical sense for this type of device.
4. Adjudication Method for the Test Set
This is not applicable as the testing described is technical bench testing, not a clinical trial requiring adjudication of patient outcomes or interpretations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. These are typically for diagnostic devices where human reader performance is being evaluated, often with and without AI assistance. This document is for a physical medical device (dental abutment) and focuses on mechanical and physical properties.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was done
This is not directly applicable. A "standalone" study usually refers to the performance of an algorithm or AI without human intervention. While the device itself functions without continuous human interaction once implanted, the performance evaluation here is on its manufactured properties and compatibility, not an "algorithm's" diagnostic accuracy. The bench tests described could be considered "standalone" in that they evaluate the device itself.
7. The Type of Ground Truth Used
For the described performance testing (tolerance analysis, functional fit checks, fatigue testing), the "ground truth" would be engineering specifications, material properties, and regulatory standards (e.g., ISO 14801 for fatigue testing, or dimensional specifications for fit). It is not expert consensus, pathology, or outcomes data in the clinical sense.
8. The Sample Size for the Training Set
This is not applicable. There is no mention of a "training set" as this is not an AI/ML device that requires data for model training.
9. How the Ground Truth for the Training Set was Established
This is not applicable as there is no training set for this 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.)