(447 days)
The 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.
It is compatible with the following systems:
· Tapered Internal Implants (K071638) (K143022) 3.4, 3.8, 4.6, 5.8 mm
- · BioHorizons Laser-Lok Implant System (K093321) 3.0 mm
The available range of diameters is summarized below:
Tapered Internal / Laser-Lok 3.0
Implant Ø (mm) : 3.0 / Implant Platform (mm) : 3.0 / Type of Implant-Abutment Connection : Internal Hex Tapered Internal
Implant Ø (mm) : 3.4 / Implant Platform (mm) : 3.0 / Type of Implant-Abutment Connection : Internal Hex
Implant Ø (mm) : 3.8 / Implant Platform (mm) : 3.5 / Type of Implant-Abutment Connection : Internal Hex
Implant Ø (mm) : 4.6 / Implant Platform (mm) : 4.5 / Type of Implant-Abutment Connection : Internal Hex
Implant Ø (mm) : 5.8 / Implant Platform (mm) : 5.7 / Type of Implant-Abutment Connection : Internal Hex
All digitally designed abutments and/or coping for use with the TruAbutments are intended to be sent to a TruAbutment-validated milling center for manufacture.
The TruAbutment DS system includes patient-specific abutments which are placed into the dental implant to provide support for a prosthetic restoration. The subject abutments are indicated for cemented or "Screw- and Cement-Retained Prosthesis" (SCRP) restorations. The patient-specific abutment and 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 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.
The provided document describes the FDA 510(k) clearance for the TruAbutment DS, a patient-specific CAD/CAM abutment. It does not contain information typically found in an AI/ML device approval, such as acceptance criteria related to classification metrics (e.g., sensitivity, specificity, AUC), sample size for test sets (in the context of AI models), number of experts for ground truth, adjudication methods, MRMC studies, standalone performance of an algorithm (as this is a physical device, not an algorithm), or information about training datasets.
The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this document refer to the non-clinical testing performed for the physical dental abutment device, primarily focusing on its mechanical performance and compatibility with existing implants.
Here's the information parsed from the document based on the device type:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Fatigue Test (ISO 14801:2016) | Met the standard for finished assembled implant/abutment systems (worst-case scenario: smallest diameter with maximum angulation). |
| End User Steam Sterilization | Met standards: ISO 17665-1:2006, 17665-2:2009, and ANSI/AAMI ST79:2010 (leveraged from reference device K152559). |
| Biocompatibility Tests | Met standards: ISO 10993-1:2009, ISO 10993-5:2009, and ISO 10993-10:2010 (leveraged from reference device K152559). |
| Dimensional Analysis and Reverse Engineering | Demonstrated implant to abutment compatibility: assessment of maximum/minimum dimensions, tolerances, and cross-sectional images of the submission device, compatible implant body, OEM implant body, OEM implant abutment, and OEM abutment screw. |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: The document mentions "finished assembled implant/abutment systems of the worst-case scenario" for fatigue testing. It does not specify a numerical sample size but implies a representative selection for worst-case evaluation. For sterilization and biocompatibility, the tests were "performed for reference device K152559 and leveraged for the subject device," without specifying its sample size.
- Data Provenance: Not applicable in the context of clinical data for AI/ML. The tests are non-clinical, performed in a lab setting.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The ground truth for this physical device is based on objective engineering standards (ISO standards, dimensional measurements, material properties), not expert interpretation of medical images or conditions.
4. Adjudication method for the test set:
- Not applicable, as this is not a study requiring adjudication of interpretations.
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. TruAbutment DS is a physical dental implant component, not an AI-assisted diagnostic or prognostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm. The device itself is "standalone" in function as it's a physical component.
7. The type of ground truth used:
- Engineering Standards and Measurements: The ground truth for evaluating TruAbutment DS is based on established international (ISO) and national (ANSI/AAMI) engineering standards for medical devices (specifically dental implants and abutments), material specifications (ASTM Standard F-136 for Ti-6A1-4V ELI), and precise dimensional measurements and compatibility assessments.
8. The sample size for the training set:
- Not applicable, as this is not a machine learning model.
9. How the ground truth for the training set was established:
- Not applicable, as this is not a machine learning model.
§ 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.)