(303 days)
TruAbutment DS is a patient-specific CAD/CAM abutment, directly connected to endosseous dental implants and is intended for use as an aid in prosthetic rehabilitation.
TruBase is a titanium component that is directly connected to endosseous dental implants to provide support for patient-specific prosthetic restorations, such as copings or crowns. It is indicated for screw-retained single tooth or cement-retained single tooth and bridge restorations.
TruAbutment DS system includes patient-specific abutments which are placed into the dental implant to provide support for prosthetic restoration. The subject abutments are indicated for cemented or screw-retained restorations. The patient-specific abutment screw are made of Titanium grade Ti-6A1-4V ELI (meets ASTM Standard F-136). Each patient-specific abutment is supplied with two identical screws which are used for: (1) For fixing into the endosseous implant (2) For dental laboratory use during construction of related restoration. The abutment is placed over the implant shoulder and mounted into the implant with the provided screw. The design and manufacturing of the patient-specific abutments take into consideration the shape of the final prosthesis based on the patient's intra-oral indications using CAD/CAM system during the manufacturing. All manufacturing processes of TruAbutment DS are conducted at the TruAbutment milling center and provided to the authorized end-user as a final patient-specific abutment.
TruBase 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. TruBase abutments are made of titanium alloy conforming to ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications and are provided in various prosthetic platform diameters. CAD/CAM customized superstructure that composes the final abutment must be designed and milled through the 3Shape Abutment Designer Software, according to the prosthetic planning and patient clinical situation. The superstructure is cemented to the TruBase in the lab. Use "RelyX Unicem 2Automix" as an adhesive extra orally to connect. TruBase is provided non-sterile therefore must be sterilized after the cementation of the customized superstructure on the TruBase.
The provided text describes the regulatory clearance for the TruAbutment DS and TruBase devices, citing substantial equivalence to predicate devices, and includes details about non-clinical testing. However, it does not contain information about a study proving device performance against specific acceptance criteria for AI or algorithmic performance. The studies mentioned are focused on mechanical and biocompatibility testing of the physical dental implant abutments.
Therefore, for aspects related to AI/algorithmic performance, sample sizes, expert ground truth, adjudication, and MRMC studies, the information is not present in the provided document.
Here's a breakdown of the available information:
1. Acceptance Criteria and Reported Device Performance
The document describes "Design Limitations" for both TruAbutment DS and TruBase, which can be interpreted as design acceptance criteria. It also references compatibility and mechanical performance tests.
TruAbutment DS Design Limitations / Reported Performance:
| Design parameter | Acceptance Criteria (Design Limit) | Reported Device Performance |
|---|---|---|
| Minimum and Maximum abutment angle | 0~25° | - (Meets criteria as per "Conclusion") |
| Minimum and Maximum Cuff Height | 0.5~6.0mm | - (Meets criteria as per "Conclusion") |
| Minimum and Maximum diameter at the abutment/implant interface | Ø3.8mm~Ø8.0mm | - (Meets criteria as per "Conclusion") |
| Minimum Thickness | 0.4 mm | - (Meets criteria as per "Conclusion") |
| Minimum and Maximum length of abutment post (length above the abutment collar/gingival height) | 4~7 mm | - (Meets criteria as per "Conclusion") |
TruBase / Zirconia Superstructure Design Limitations / Reported Performance:
| Design parameter | Acceptance Criteria (Design Limit) | Reported Device Performance |
|---|---|---|
| Minimum and Maximum abutment angle | 0~15° | - (Meets criteria as per "Conclusion") |
| Minimum and Maximum Cuff Height | 0.5~5 mm | - (Meets criteria as per "Conclusion") |
| Minimum and Maximum diameter at the abutment/implant interface | Ø5.0mm~Ø8.0mm | - (Meets criteria as per "Conclusion") |
| Minimum Thickness | 0.4 mm | - (Meets criteria as per "Conclusion") |
| Minimum and Maximum length of abutment post (length above the abutment collar/gingival height) | 4~6 mm | - (Meets criteria as per "Conclusion") |
Mechanical Performance:
- Acceptance Criteria: Met the criteria of ISO 14801:2016 and FDA Guidance "Class II Special Controls Guidance Document: Rootform Endosseous Dental Implants and Endosseous Dental Implant Abutments."
- Reported Device Performance: "The fatigue limit data for all other implant lines demonstrated the construct strengths to be sufficient for their intended use."
Sterilization Validation:
- Acceptance Criteria: Met the criteria of ISO 17665-1:2006, 17665-2:2009, and ANSI/AAMI ST79:2010.
- Reported Device Performance: Achieved through end-user moist steam sterilization.
Biocompatibility:
- Acceptance Criteria: Met the criteria of ISO 10993-1:2009, ISO 10993-5:2009, and ISO 10993-10:2010.
- Reported Device Performance: Not explicitly stated as "passed" for the subject device, but mentioned it was leveraged from predicate device testing and supports substantial equivalence.
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: For mechanical testing (ISO 14801), "worst-case constructs" were subjected to static compression and compression fatigue testing for each compatible OEM implant line. The exact number of samples is not specified.
- Data Provenance: Not specified; the context implies laboratory testing. The document does not refer to real-world patient data for performance evaluation in the context of AI.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The tests performed are non-clinical (mechanical, sterilization, biocompatibility) of physical devices, not assessments requiring expert interpretation of data or images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable for non-clinical, physical device testing.
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
Not applicable. No AI component is described in the performance evaluation section for either TruAbutment DS or TruBase. The software mentioned (3Shape Abutment Designer Software) is for CAD/CAM design, which is a tool for designing the physical device, not an AI for diagnosis or interpretation that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. As noted above, the device itself is a physical dental abutment, and its design process involves CAD/CAM software, not a standalone AI algorithm for medical decision-making or image analysis.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Mechanical Testing: Ground truth is established by the specified ISO standards (ISO 14801) and FDA guidance, defining acceptable force and fatigue limits for dental implant systems.
- Dimensional Analysis: Ground truth is against design specifications and reverse engineering of OEM implant-to-abutment connections.
- Sterilization: Ground truth is against ISO 17665-1:2006, 17665-2:2009, and ANSI/AAMI ST79:2010 standards for sterilization efficacy.
- Biocompatibility: Ground truth is against ISO 10993 standards for biological safety.
8. The sample size for the training set
Not applicable. The document describes a physical medical device and its manufacturing process, not an AI/ML algorithm that requires a training set. The CAD/CAM software aids in design, but the document does not detail its internal development or any associated training sets.
9. How the ground truth for the training set was established
Not applicable, as no training set for an AI/ML algorithm is described.
§ 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.)