(101 days)
Inclusive® Titanium Abutments are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation.
Inclusive® Titanium Abutments are compatible with:
- Biomet: 3i Certain internal hex implants in 3.4, 4.1, 5.0, 6.0 mm sizes -
- -Nobel Biocare: NobelReplace straight and tapered internal connection implants in NP, RP, WP, 6.0 mm sizes
- -Zimmer: Screw-Vent and Tapered Screw-Vent internal hex implants in 3.5, 4.5, 5.7 mm sizes
Inclusive Titanium Abutments are endosseous implant abutments which are placed into the dental implant to provide support for a prosthetic restoration. The abutment is placed over the implant shoulder and is fastened into the implant with a screw. Abutments are made of titanium grade 23 (Ti-6AL-4V ELI) and meet ASTM F-136 Standard.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Inclusive® Titanium Abutments.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria for the device beyond demonstrating substantial equivalence to predicate devices. However, the non-clinical testing performed implicitly defines performance metrics that align with the safety and effectiveness requirements of the predicate devices.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Reliability (e.g., structural integrity, consistency) | Reliability Calculation performed. The testing "established that the predicate device is as safe, as effective, and performs as well as the predicate device(s)." (implies meeting established reliability standards) |
| Fatigue Life (resistance to repeated stress) | Fatigue Testing of finished assembled implant/abutment systems performed. The testing "established that the predicate device is as safe, as effective, and performs as well as the predicate device(s)." (implies meeting or exceeding predicate device's fatigue performance) |
| Static Load Failure (resistance to maximum applied force) | Static Load Failure Testing of finished assembled implant/abutment systems performed. The testing "established that the predicate device is as safe, as effective, and performs as well as the predicate device(s)." (implies meeting or exceeding predicate device's static load failure threshold) |
| Implant to Abutment Compatibility (proper fit and connection) | Demonstrated "implant to abutment compatibility" through testing. |
| Sterilization Efficacy | Sterilization validation information and a recommended sterilization method based on ANSI/AAMI ST79 and ISO 17665-1 is provided. (Implies the device can be effectively sterilized according to recognized standards). |
| Equivalence in Intended Use | Stated as "substantially equivalent ... in intended use" to predicate devices. The "Indications for Use" statement is similar to predicate devices, though wording varies. |
| Equivalence in Materials | Stated as "substantially equivalent ... in materials." Made of titanium grade 23 (Ti-6AL-4V ELI) meeting ASTM F-136 Standard, same as predicate devices. |
| Equivalence in Design | Stated as "substantially equivalent ... in design" to predicate devices, with detailed comparison tables showing high similarity in dimensions, connection types, design/construction (machined), anatomical site, implant seat, and screw seat. Note: Abutment angle range has increased. |
| Equivalence in Performance | Stated as "substantially equivalent ... in performance" to predicate devices, supported by the non-clinical testing results. |
2. Sample Size Used for the Test Set and Data Provenance
The document states that "Non-clinical test data was used to evaluate the device's safety and effectiveness." However, it does not specify the sample sizes used for the Reliability Calculation, Fatigue Testing, or Static Load Failure Testing.
The data provenance is non-clinical testing, performed by the manufacturer, Prismatik Dentalcraft, Inc. It's an engineering and materials testing study, not a human clinical study, so concepts like "country of origin of data" or "retrospective/prospective" in the typical sense for clinical trials are not directly applicable. These would be laboratory-generated data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable in the context of this device. The "ground truth" for non-clinical engineering tests (like fatigue or static load failure) is determined by established engineering standards and physical failure points, not by expert consensus on interpretations. The "ground truth" for material composition is based on material specifications (ASTM F-136 Standard).
4. Adjudication Method for the Test Set
This is not applicable for the type of non-clinical testing described. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies or image interpretation studies where multiple human readers assess data and discrepancies need to be resolved. The non-clinical tests involve objective measurements and failure points.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret medical data (e.g., images) with and without AI assistance. The device in question is a dental implant abutment, which is a physical component, not a diagnostic AI tool.
6. Standalone (Algorithm only without human-in-the-loop performance) Study
Yes, in spirit, a standalone performance study was done. The device itself is a physical component (an abutment), and the performance testing (Reliability, Fatigue, Static Load Failure) evaluates the device's intrinsic mechanical properties and compatibility with implants, independent of human interaction during its function. The "human in the loop" for an abutment is a dentist placing it and a patient using it, but the tests conducted are assessing the device's inherent physical performance, which is "standalone" in that context. There's no "algorithm" here, but the physical device's performance was evaluated independently.
7. Type of Ground Truth Used
The "ground truth" for the non-clinical tests was based on:
- Engineering Standards: Referenced FDA Guidance "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments," and implicitly, the performance characteristics of the legally marketed predicate devices.
- Material Specifications: ASTM F-136 Standard for titanium grade 23 (Ti-6AL-4V ELI).
- Objective Physical Failure Points: Mechanical failure under controlled loading conditions.
- Established Sterilization Standards: ANSI/AAMI ST79 and ISO 17665-1.
8. Sample Size for the Training Set
This is not applicable. The device is a physical medical device, not a machine learning or AI algorithm that requires a "training set" of data. The manufacturing process and design are based on established engineering principles and materials science, not statistical learning from data.
9. How the Ground Truth for the Training Set Was Established
This 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.)