(275 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. It is compatible with the following systems:
- · MIS C1 Conical Connection Implant (K172505, K112162)
- : 3.3 (NP) 3.75, 4.2, 5.0 (SP, WP)
- · Neodent Implant System GM Helix (K163194, K180536)
- : 3.5, 3.75, 4.0, 4.3, 5.0 (3.0) 6.0 (3.0)
- · Nobel Biocare Groovy Implants (K050258)
- : 3.5. 4.3, 5.0, 6.0 (NP, RP, WP, 6.0)
- · Straumann BLX Implant (K173961, K181703, K191256)
- : 3.5, 3.75, 4.0, 4.5, 5.0, 5.5, 6.5 (RB, WB)
- · Straumann Tissue Level Implant (K111357)
- : 3.3(NNC)
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.
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. It is compatible with the following systems:
- · MIS C1 Conical Connection Implant (K172505, K112162)
- : 3.3 (NP) 3.75, 4.2, 5.0 (SP, WP)
- · Neodent Implant System GM Helix (K163194, K180536)
- : 3.5, 3.75, 4.0, 4.3, 5.0 (3.0) 6.0 (3.0)
- · Nobel Biocare Groovy Implants (K050258)
- : 3.5. 4.3, 5.0, 6.0 (NP, RP, WP, 6.0)
- · Straumann BLX Implant (K173961, K181703, K191256)
- : 3.5, 3.75, 4.0, 4.5, 5.0, 5.5, 6.5 (RB, WB)
- · Straumann Tissue Level Implant (K111357)
- : 3.3(NNC)
All digitally designed zirconia superstructure for use with the TruBase are intended to be sent to a TruAbutment-validated milling center for manufacture.
TruAbutment DS system includes patient-specific abutments which are placed into the dental implant to provide support for the prosthetic restoration. The subject abutments are indicated for cemented or screw-retained restorations. The patient-specific abutment and abutment screw are made of Titanium grade Ti-6A1-4V ELI (meets ASTM Standard F-136). Each patientspecific 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. The system also includes a TruBase screw for fixation to the implant body.
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. The TruBase screws are composed of titanium alloy per ASTM F136.
CAD/CAM customized superstructure that composes the final abutment is 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 in the lab.
The provided text is a 510(k) summary for the TruAbutment DS and TruBase devices, which are endosseous dental implant abutments. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed "acceptance criteria" and results from a study proving the device meets those specific criteria in the way one might find for a novel AI/software medical device.
The document discusses performance in terms of mechanical resistance and dimensional compatibility to ensure long-term functional performance with dental implants. However, it does not outline distinct "acceptance criteria" that are then verified by a specific study with a defined sample size, ground truth, or expert adjudication as typically seen in AI/ML validation. Instead, it relies on demonstrating compliance with recognized standards and comparability to a predicate device.
Given the information provided, here's an attempt to answer the questions based on the context of this 510(k) summary, interpreting "acceptance criteria" as the performance expectations set by the applicable standards and "study" as the non-clinical testing performed:
1. A table of acceptance criteria and the reported device performance
The document doesn't explicitly state "acceptance criteria" in a tabular format with corresponding reported performance for a comparative AI study. Instead, it refers to compliance with established standards for dental implant abutments. The closest equivalent to "acceptance criteria" for the mechanical performance is meeting the requirements of ISO 14801.
| Acceptance Criteria (Derived from Standards/Comparisons) | Reported Device Performance |
|---|---|
| Mechanical Performance: Fatigue limit based on ISO 14801:2016 for worst-case constructs of compatible OEM implant lines. | "The fatigue limit data for all other implant lines demonstrated the construct strengths to be sufficient for their intended use." (Implies compliance with ISO 14801, i.e., meeting or exceeding the minimum required fatigue strength as per the standard). |
| Dimensional Compatibility: Assessment of maximum and minimum dimensions of critical design aspects, tolerances, and cross-sectional images of the submission device and compatible OEM implant body, OEM abutment, and OEM fixation screw. | "The testing demonstrated implant to abutment compatibility" |
| Sterilization: Compliance with ISO 17665-1:2006, 17665-2:2009 and ANSI/AAMI ST79:2010. | "Sterilization validation for the subject devices (TruAbutment DS, TruBase) was performed according to ISO 17665-1 and ISO 17665-2. This sterilization method is the same as the primary predicate devices (K202579)." |
| Biocompatibility: Compliance with ISO 10993-1:2009, ISO 10993-5:2009, and ISO 10993-10:2010. | "Biocompatibility tests according to ISO 10993-1:2009, ISO 10993-5:2009, and ISO 10993-10:2010. The results of the above tests have met the criteria of the standard..." |
2. Sample size used for the test set and the data provenance
The document does not specify a "test set" sample size in the context of an AI/ML model for image analysis or diagnostics. The testing described is primarily non-clinical mechanical testing, dimensional analysis, and biocompatibility testing of physical devices.
- Sample Size: Not specified in terms of "number of cases" or "patients" for a diagnostic study. For mechanical testing, samples would be physical devices/constructs. The number of samples for ISO 14801 fatigue testing is typically defined by the standard itself (e.g., typically 3 samples for static and 15 samples for fatigue for each configuration).
- Data Provenance: Not applicable in the sense of patient data or images. The "data" comes from physical testing of manufactured devices.
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 to the type of device and testing described. The "ground truth" for mechanical properties is established by physical measurement against engineering specifications and performance under defined load conditions, not by expert human interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no human interpretation or subjective assessment involved that would require an adjudication method.
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. The device is a physical dental implant abutment, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device is a physical dental implant abutment, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this medical device is based on engineering specifications, material science standards (e.g., ASTM F136), and mechanical testing standards (e.g., ISO 14801). For example, mechanical strength and fatigue life are measured directly, and dimensional compatibility is assessed against design tolerances.
8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires a training set. The "design" of the abutments is based on CAD/CAM systems informed by engineering principles, not machine learning from large datasets.
9. How the ground truth for the training set was established
Not applicable. As this is not an AI/ML device, there is no "training set" or "ground truth for the training set" in the context of machine learning. The knowledge base for the CAD/CAM design and manufacturing is derived from established dental and engineering principles, material science, and regulatory standards.
§ 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.)