(176 days)
The Tru Abutment 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:
- · Astra Tech OsseoSpeed™ EV 3.0. 3.6, 4.2, 4.8, 5.4 mm
- · Nobel Active™ Internal Connection Implant 3.5, 4.3, 5.0, 5.5 mm
- · Straumann® Bone Level Implants 3.3, 4.1, 4.8 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 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-I 36). 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. 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.
Mechanical resistance of the implant-abutment connection is essential to ensure correct long-term functional performance of the complete dental restoration. Dimensional compatibility and mechanical performance of bases and screws together with the underlying implant are of primary importance. These concepts are the basis upon which the system design characteristics and functional performance are established.
The proposed patient-specific abutments are available in internal connections and are compatible with:
The provided text describes the regulatory submission for the TruAbutment DS, a patient-specific CAD/CAM abutment for dental implants. The core of the submission is to demonstrate "substantial equivalence" to existing predicate devices, rather than proving effectiveness through a traditional clinical study with defined acceptance criteria and effect sizes.
Therefore, the information you're asking for regarding acceptance criteria, sample sizes for test/training sets, expert adjudication, MRMC studies, standalone performance, and ground truth establishment is not directly applicable or available in this document in the way it would be for a machine learning or AI-driven device performance study.
This document focuses on non-clinical testing to demonstrate the physical performance and compatibility of the device.
Here's how to address your request based on the provided document:
Acceptance Criteria and Device Performance
The "acceptance criteria" here are defined by the relevant ISO standards and FDA guidance for dental implant abutments, specifically related to mechanical integrity and biocompatibility, as well as dimensional compatibility with specified implant systems. The "device performance" is reported as having met these criteria.
Table of Acceptance Criteria and Reported Device Performance (Based on Non-Clinical Testing):
| Acceptance Criteria Category | Specific Criteria (Standard/Guidance) | Reported Device Performance |
|---|---|---|
| Mechanical Performance | Fatigue Test according to ISO 14801:2007 (for worst-case scenario: smallest diameter with maximum angulation) | Results met the criteria of the standard; demonstrated substantial equivalence. |
| Material Biocompatibility | Biocompatibility tests according to ISO 10993-1:2009, ISO 10993-5:2009, and ISO 10993-10:2010 | Results met the criteria of the standard; demonstrated substantial equivalence. |
| Sterilization | End User Steam Sterilization Test according to ISO 17665-1:2006, 17665-2:2009 and ANSI/AAMI ST79:2010 | Results met the criteria of the standard; demonstrated substantial equivalence. |
| Dimensional Compatibility | Dimensional analysis and reverse engineering (OEM implant bodies, abutments, fixation screws) | Demonstrated implant to abutment compatibility and established substantial equivalency. |
| Regulatory Compliance | FDA Guidance "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments" | Testing was conducted in accordance with this guidance. |
Study Details (as inferable from the document):
Since this is a submission for a physical medical device (dental abutment) and a demonstration of substantial equivalence rather than a novel AI/ML algorithm, most of your specific questions about data sets, experts, and MRMC studies do not apply.
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Sample size used for the test set and the data provenance:
- Sample Size (Test Set): Not explicitly stated as a "test set" in the context of an algorithm. The "test set" here refers to the physical samples of the TruAbutment DS device and compatible implant systems that underwent non-clinical laboratory testing (fatigue, biocompatibility, sterilization, dimensional analysis). The document mentions "worst-case scenario" testing (smallest diameter with maximum angulation), implying a targeted selection of test articles rather than a large, randomized "test set" as understood in a data science context. The exact number of samples for each test (e.g., number of abutments for fatigue testing) is not provided.
- Data Provenance: The document does not specify the country of origin of the data beyond the standards being international (ISO, ANSI/AAMI). The testing was "non-clinical testing," performed in a laboratory setting. It is retrospective in the sense that the results are being leveraged for a new device submission (K172304), and some tests were performed for a prior predicate device (K152559) and leveraged.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. "Ground truth" in this context refers to the validated performance of a physical device against established engineering and biological standards. This is determined by laboratory measurements and adherence to specified test protocols, not by expert consensus on data annotations for an AI model.
- The "experts" would be the engineers and scientists conducting and validating the lab tests according to the standards. Their qualifications are not specified but would be implicit in their ability to conduct such highly technical and regulated testing.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. This concept is relevant for reconciling discrepancies in human annotations or interpretations for ground truth establishment in AI/ML. For physical device testing, the "ground truth" is defined by the technical specifications and the results of validated laboratory tests.
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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, not done. This type of study (MRMC) is for evaluating diagnostic performance of AI-assisted human readers. The TruAbutment DS is a physical medical device (dental abutment), not an AI/ML diagnostic tool. The document explicitly states: "Clinical testing was not necessary to establish substantial equivalency of the device."
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. As above, this is not an AI/ML algorithm. Its "standalone" performance means its physical properties and mechanical integrity, which were evaluated through non-clinical laboratory tests.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device's performance is established by engineering standards (ISO 14801), biocompatibility standards (ISO 10993 series), sterilization standards (ISO 17665, ANSI/AAMI ST79), and dimensional analysis via reverse engineering. These are objective, empirically measured outcomes from laboratory testing, not human-derived consensus or clinical outcomes data.
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The sample size for the training set:
- Not Applicable. There is no "training set" in the context of an AI/ML algorithm for this device. The design and manufacturing process for the TruAbutment DS would have been developed iteratively (similar to an engineering "training phase"), but not with a structured data "training set" in the AI sense.
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How the ground truth for the training set was established:
- Not Applicable. See point 7. The "ground truth" during the development of such a device would be based on design specifications, material properties, and iterative engineering testing to ensure the device meets its intended functional requirements and complies with relevant 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.)