(333 days)
TruBase S is a titanium component that is directly connected to endosseous dental implants to provide support for custom prosthetic restorations, such as copings or crowns. It is indicated for a screw-retained single tooth or cement-retained single tooth and bridge restorations. It is compatible with the following systems:
• NobelActive (K102436, K071370, K133731): 3.0, 3.5, 4.3, 5.0, 5.5 (3.0, NP, RP, WP)
All digitally designed abutments and/or copings for use with TruBase S are intended to be sent to a TruAbutmentvalidated milling center for manufacture.
TruBase S consists of a two-piece abutment, where the titanium base is a pre-manufactured abutment that will be used to support a CAD/CAM designed superstructure (the second part of the two-piece abutment) that composes the final abutment. The system also includes a TruBase S Screw for fixation to the implant body.
TruBase S abutments are made of titanium alloy conforming to ASTM F 136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications and are provided in various prosthetic platform diameters (NobelActive 3.0, NP, RP, WP). The TruBase S Screws are composed of titanium alloy per ASTM F136.
They also feature:
- . cylindrical shape
- hexagonal indexing at the apical end of the connection ●
- indexing guide in the cementable portion for coping fitting ●
CAD/CAM customized superstructure that composes the final abutmentis intended to be sent to a TruAbutment-validated milling center to be designed and milled, according to the prosthetic planning and patient clinical situation. The superstructure is cemented to the TruBase S in the lab. Use "RelyX Unicem 2Automix" as an adhesive extra orally to connect.
TruBase S is provided non-sterile therefore must be sterilized after the cementation of the customized superstructure on the TruBase S.
The provided document describes a 510(k) premarket notification for a dental implant abutment, TruBase S. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving novel clinical effectiveness. As such, the information you're looking for regarding AI-specific criteria, clinical study designs, human reader performance, or training set details associated with an AI-driven device is largely not present in this document.
However, I can extract the acceptance criteria and study details relevant to the mechanical performance and substantial equivalence of this medical device.
1. A table of acceptance criteria and the reported device performance
The acceptance criteria for mechanical performance are implicitly set by compliance with ISO 14801:2016 for fatigue testing. The document states that the test results "met the criteria of the standard." For design parameters, the acceptance criteria are substantial equivalence to the predicate device, K201197.
| Acceptance Criteria Category | Specific Acceptance Criterion | Reported Device Performance |
|---|---|---|
| Material | Ti-6Al-4V ELI (ASTM F 136) for Abutment and Screw | Complies: TruBase S abutments are made of titanium alloy conforming to ASTM F 136. TruBase S Screws are composed of titanium alloy per ASTM F136. |
| Design Parameters (CAD) | Minimum and Maximum abutment angle (°) : 0~15 | 0~15 |
| Minimum and Maximum Cuff Height (mm): 0.5~5.0 | 0.5~5.0 | |
| Minimum and Maximum diameter at abutment/implant interface (Ø, mm): 5.0~8.0 | 5.0~8.0 | |
| Minimum Thickness (mm): 0.4 | 0.4 | |
| Minimum and Maximum length of abutment post (length above the abutment collar/gingival height) (mm): 4.0~6.0 | 4.0~6.0 | |
| Mechanical Performance | Fatigue testing according to ISO 14801:2016 requirements | "The results of the above tests have met the criteria of the standard." "The fatigue limit data for all other implant lines demonstrated the construct strengths to be sufficient for their intended use." |
| Implant-to-abutment compatibility | "The testing demonstrated implant to abutment compatibility and has established substantial equivalency of the proposed device with predicate devices." (Through dimensional analysis and reverse engineering) | |
| Sterilization | End User Steam Sterilization Test according to ISO 17665-1:2006, 17665-2:2009 and ANSI/AAMI ST79:2010. | Leveraged from predicate device (K201197), which performed these tests with results meeting criteria. TruBase S is provided non-sterile and must be sterilized. |
| Biocompatibility | Biocompatibility tests according to ISO 10993-1:2009, ISO 10993-5:2009, and ISO 10993-10:2010. | Leveraged from predicate device (K201197), which performed these tests with results meeting criteria. As the materials are the same (Ti-6Al-4V ELI and InCoris Zi), the biocompatibility is assumed to be equivalent. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify a distinct "test set" in the context of an AI-driven device or clinical study. The testing performed was non-clinical mechanical performance testing on physical devices and based on technical specifications and design parameters.
- Sample Size: For the fatigue testing, the document mentions "worst-case constructs" were subjected to testing, and "the fatigue limit data for all other implant lines demonstrated the construct strengths to be sufficient." However, specific numerical sample sizes for these tests are not provided.
- Data Provenance: The data originates from internal non-clinical testing conducted by the manufacturer or accredited labs for mechanical and material properties. No country of origin is specified for these tests. The nature of these tests is prospective in the sense that they are conducted specifically for the submission, but they are not clinical studies.
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 information is not applicable. The device is a physical dental implant abutment, not an AI device that requires expert ground truth labeling for image analysis or diagnostic purposes. The "ground truth" for its performance is established through adherence to engineering standards (ISO 14801) and material specifications (ASTM F 136).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical trials or studies where human interpretation of data (e.g., medical images) is compared with an AI's output, often involving multiple experts to resolve discrepancies. This device's evaluation relies on objective mechanical and material testing, not human interpretation or 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
This information is not applicable. This device is a physical dental implant abutment and is not an AI-driven diagnostic or assistive device that would participate in an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. This device is a physical dental implant component, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this medical device is based on:
- Material Specifications: Adherence to ASTM F 136 for titanium alloy.
- Engineering Standards: Compliance with ISO 14801:2016 for fatigue testing, and ISO 17665-1/2 and ANSI/AAMI ST79 for sterilization.
- Biocompatibility Standards: Compliance with ISO 10993 series.
- Dimensional and Design Parameters: Matching the design limits established by the predicate device and compatible OEM implant lines.
8. The sample size for the training set
This information is not applicable. There is no concept of a "training set" for this physical medical device. Manufacturing processes are based on established engineering principles and quality control, not machine learning training.
9. How the ground truth for the training set was established
This information is not applicable, as there is no training set for this physical medical 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.)