(338 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:
- · Biomet 3i Certain® (K130949) 3.25, 4.0, 5.0, 6.0 mm
- · DIO UF(II) Internal Submerged (K161987, K170608, K173975) 3.3, 3.8, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0 mm
- Megagen AnyRidge® (K140091) 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0 mm
- · Neoss ProActive® (K083561) 3.25, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0 mm
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 custom abutments which are placed into the dental implant to provide support for a prosthetic restoration. The subject abutments are indicated for screwretained restorations. The custom 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 custom 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 proposed abutments are available in internal hex connection, and are compatible with Biomet 3i Certain® Implant/DIO UF(II) Internal Submerged Implant/Megagen AnyRidge® Implant/Neoss ProActive® Implant.
The device being discussed is "TruAbutment DS", a patient-specific CAD/CAM abutment for dental implants.
The acceptance criteria for this device are established by demonstrating substantial equivalence to a predicate device (TruAbutment DS K170259) through non-clinical testing, primarily mechanical performance (fatigue) testing, and biocompatibility assessments. The study described focuses on non-clinical testing to meet these acceptance criteria rather than a clinical study.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Set by Standards & Guidance) | Reported Device Performance (as demonstrated by testing) | Equivalence Discussion |
|---|---|---|
| Mechanical Performance: Meets ISO 14801:2007 (dynamic fatigue with static compression) and FDA Guidance "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments" to demonstrate sufficient strength for intended use. | Comparative fatigue testing conducted according to ISO 14801 and FDA Guidance. Worst-case constructs (smallest diameter with maximum angulation) were subjected to static compression and compression fatigue. The fatigue limit data for all implant lines demonstrated the construct strengths to be sufficient for their intended use. | Equivalent. The testing demonstrated implant to abutment compatibility and established substantial equivalency. |
| Material Biocompatibility: Meets ISO 10993-1:2009, ISO 10993-5:2009, and ISO 10993-10:2010. | Biocompatibility tests performed according to ISO 10993 series. Results met the standards. | Equivalent. No concerns regarding material. |
| End User Steam Sterilization: Meets ISO 17665-1:2006, 17665-2:2009 and ANSI/AAMI ST79:2010. | End User Steam Sterilization Test performed according to specified ISO and ANSI/AAMI standards. | Equivalent. Confirmed sterility methods for end-user. |
| Dimensional Compatibility: Demonstrates compatibility with specified OEM implant systems (Biomet 3i Certain®, DIO UF(II) Internal Submerged, Megagen AnyRidge®, Neoss ProActive®). | Dimensional analysis and reverse engineering of the implant-to-abutment connection platform were performed, assessing maximum/minimum dimensions, tolerances, and cross-sectional images of the submission device and compatible implants. | Equivalent. Demonstrated implant to abutment compatibility. Minor differences in compatible OEM implant lines are mitigated by mechanical testing. |
2. Sample size used for the test set and the data provenance
The document does not explicitly state the exact sample size (number of abutments or implants) used for the non-clinical mechanical and dimensional tests. It mentions "worst-case constructs" for fatigue testing.
Data provenance: The testing was conducted by the manufacturer (TruAbutment Inc.) as part of their 510(k) submission to the FDA, presumably in the USA (where the company is based). The data is retrospective as it was generated specifically for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable. The "ground truth" for this device's performance is established by meeting recognized international and national standards (ISO, FDA guidance) through non-clinical laboratory testing, not by expert consensus on clinical cases.
4. Adjudication method for the test set
This is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or studies involving human interpretation of medical images. The studies performed for this device were non-clinical laboratory tests.
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
No, an MRMC comparative effectiveness study was not done. This device is a physical dental implant abutment, not an AI or imaging diagnostic tool that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This device is a physical medical device, not an algorithm. The "standalone" performance is assessed by its mechanical integrity and biocompatibility when used as intended.
7. The type of ground truth used
The "ground truth" used for this device is based on established engineering and materials science principles and validated standards:
- Mechanical Performance: Defined by the specified fatigue limits and static load capabilities as per ISO 14801 and FDA guidance thresholds for dental implant abutments.
- Biocompatibility: Defined by the absence of adverse biological reactions as per ISO 10993 series standards.
- Dimensional Accuracy: Defined by precise measurements confirming compatibility with target implant systems.
8. The sample size for the training set
This is not applicable. This device is not an AI model that requires a training set. The CAD/CAM design process for patient-specific abutments involves individual patient data rather than a large training dataset for device development in the AI sense.
9. How the ground truth for the training set was established
This is not applicable as there is no "training set" in the context of an AI device. The design principles for the TruAbutment DS are based on established dental implantology, engineering design, and manufacturing standards for patient-specific CAD/CAM abutments.
§ 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.)