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510(k) Data Aggregation
(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.
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(474 days)
The TruBase S 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 serew-retained single tooth or cement-retained single tooth and bridge restorations. It is compatible with the following systems:
- · Zimmer TSV 3.7, 4.1. 4.7. 6.0 mm (3.5. 4.5, 5.7mm platform sizes)
All digitally designed abutments and/or coping for use with the TruBase S are to be designed using Sirona inLab software or Sirona CEREC Software and manufactured using a Sirona CEREC or inLab MCX or MC XL milling unit.
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.
TruBase S 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 (4.3, 5.3, 6.5 mm) and four gingival heights (0.8, 1.8, 2.8, 3.8mm), all having a 4.7mm prosthetic post height. They also feature:
- cylindrical shape
- hexagonal indexing at the apical end of the connection
- indexing guide in the cementable portion for coping fitting
The CAD/CAM patient-specific superstructure that composes the final abutment must be designed and milled through the Sirona Dental CAD/CAM System, according to the prosthetic planning and patient clinical situation.
TruBase S is provided non-sterile therefore must be sterilized after the cementation of the patient-specific superstructure on the TruBase S.
The provided text describes a 510(k) premarket notification for a dental implant abutment, TruBase S, and details the non-clinical testing performed to establish its substantial equivalence to predicate devices. It does not contain information about a study proving the device meets specific acceptance criteria in the context of a clinical trial or a full performance study with human subjects, AI systems, or ground truth established by experts as would be typical for an AI/ML medical device.
The information primarily focuses on mechanical testing, material equivalence, and compatibility, which are acceptance criteria for this type of medical device's safety and effectiveness.
Here's a breakdown of the available information based on your request, with an emphasis on what is not present in the document.
1. A table of acceptance criteria and the reported device performance:
The document doesn't present a table of acceptance criteria with specific numerical performance metrics in the way you might expect for an AI/ML device (e.g., sensitivity, specificity). Instead, it states that tests met "the criteria of the standard" or "demonstrated substantial equivalence."
| Acceptance Criteria Category | Reported Device Performance | Comments |
|---|---|---|
| Fatigue Test (ISO 14801:2016) | "The results of the fatigue test have met the criteria of the standard, ISO 14801:2016, and demonstrated the substantial equivalence with the predicate device." | This implies meeting a predefined mechanical strength and durability threshold for dental implants. Specific numerical fatigue limits are not provided. |
| End User Steam Sterilization Test (ISO 17665-1:2006, 17665-2:2009, ANSI/AAMI ST79:2010) | "Below tests were performed for predicate device, K152559 and leveraged for the subject device" and it indicates "Equivalent" for sterility and end-user sterilization. | The subject device relies on predicate device testing and demonstrates equivalence in sterilization methods. Specific test results are not detailed for the subject device itself; the equivalence is based on the final sterilization by the user. |
| Biocompatibility Tests (ISO 10993-1:2009, ISO 10993-5:2009, and ISO 10993-10:2010) | "Below tests were performed for predicate device, K152559 and leveraged for the subject device" and states that "all materials are shown to be biocompatible." | The subject device leverages biocompatibility data from predicate devices, implying similar material properties and safety. |
| Dimensional Analysis and Reverse Engineering | "The testing demonstrated implant-to-abutment-to-mesostructure compatibility and has established substantial equivalency of the proposed device with predicate devices." | Confirms mechanical fit and compatibility with specified implant systems. |
| Software Verification and Validation Testing (Sirona Dental CAD/CAM System) | "The subject TruBase S was verified and validated with respect to its functionality and design using the Sirona validated workflow." and "The recommended CAD/CAM System is the same used for the primary predicate device and the validation performed was based on the validation presented by the manufacturer of the primary predicate device." | Confirms that the device works correctly within the established CAD/CAM workflow, relying on prior validation for the software system. |
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 refers to "non-clinical testing" for the TruBase S and leverages results from predicate devices for other tests. These are likely laboratory or bench tests on physical samples rather than patient data.
- Sample size for test set: Not explicitly stated as "test set" in the context of patient data. For mechanical fatigue testing, "worst-case scenario (smallest diameter with maximum angulation)" implies a specific configuration of a few physical samples, but the exact number isn't provided.
- Data provenance: Not applicable in the context of patient data. The tests are non-clinical, likely conducted in a lab environment.
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)
Not applicable. This device is a passive dental component, and its evaluation relies on engineering standards and mechanical testing, not a clinical interpretation by human experts establishing ground truth from patient data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There's no clinical imaging or diagnostic data requiring expert 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
No. This document does not pertain to an AI/ML device that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. This is not an AI/ML algorithm. The "software" mentioned is CAD/CAM software used for design and manufacturing, not an AI for diagnosis or treatment planning. The device itself is a physical dental abutment.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this type of device is established by adherence to recognized engineering standards (e.g., ISO 14801:2016 for fatigue, ISO 10993 for biocompatibility) and dimensional compatibility with existing implant systems. There is no biological or expert consensus "ground truth" as you would find for diagnostic devices.
8. The sample size for the training set
Not applicable. This is not an AI/ML device that uses a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device.
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