(80 days)
TDS Titanium Abutment for Nobel Biocare Branemark is intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient.
This device is compatible with the following implant systems which have an external hex with flat-to-flat dimensions of 2.4mm or greater: Nobel Biocare: Branemark System® Mk III Groovy, Branemark System® Mk III Shorty, Branemark System® Zygoma, NobelSpeedy Groovy, NobelSpeedy Shorty; 3i: Nano Tite External Hex Connection Implants, Full OSSEOTITE External Hex Connection Implants, OSSEOTITE External Hex Connection Implant; BioHorizons: Maestro - External Hex Implants; Lifecore: Restore External Hex Implant Systems.
TDS Titanium Abutment for Nobel Biocare Branemark are titanium abutments made of Ti-6A1-4V ELI titanium designed to be used in conjunction with specific dental implants utilizing the TDS Abutment screw, which is also made of Ti-6A1-4V ELI titanium and is used to secure the abutment to the implant. In combination with the abutments support single or multi-unit cement-retained restorations in the maxillary and/or mandibular arch. TDS Titanium Abutment for Nobel Biocare Branemark is compatible with the following implant systems which have an external hex with flat-to-flat dimensions of 2.4mm or greater: Nobel Biocare Branemark, 3i, BioHorizons, and Lifecore.
The provided text is a 510(k) summary for a dental implant abutment, not a description of a device that uses AI or machine learning. Therefore, the questions about acceptance criteria, study details, and performance metrics for an AI/ML device cannot be answered from the provided text.
The document states that the device is "substantially equivalent in indications and design principles to predicate devices." This substantial equivalence is the primary "acceptance criterion" described, implying that its performance is implicitly accepted if it is similar to already approved predicate devices. No specific quantitative performance metrics or studies proving those metrics are provided.
Here's an attempted breakdown based on the information available, emphasizing what is not present:
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A table of acceptance criteria and the reported device performance
- Acceptance Criteria: The primary acceptance criterion for the 510(k) pathway is demonstrating "substantial equivalence" to a legally marketed predicate device. This means the device has the same intended use and the same technological characteristics as the predicate, or, if it has different technological characteristics, the differences do not raise new questions of safety and effectiveness.
- Reported Device Performance: No specific performance metrics (e.g., accuracy, sensitivity, specificity, AUC) are reported for the TDS Titanium Abutment. The document states it is made of "Ti-6A1-4V ELI titanium" and is compatible with certain implant systems. This implies its mechanical and biocompatibility performance is considered equivalent to similar titanium abutments already on the market.
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Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not applicable. This device is a mechanical component (dental abutment), not an AI/ML diagnostic tool. There is no "test set" in the context of AI/ML evaluation. Performance is typically assessed through engineering design verification and validation (e.g., mechanical testing, biocompatibility studies), but details of these studies are not provided in this 510(k) summary.
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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 is not an AI/ML diagnostic device requiring expert ground truth for a test set.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable.
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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
- Not applicable. This is a medical device (dental abutment), not an AI assistance tool for human readers.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable in the AI/ML sense. For a mechanical device, "ground truth" might refer to fundamental engineering principles, material properties, and established biological responses to materials (biocompatibility). The manufacturer would rely on standards for material composition (Ti-6A1-4V ELI titanium) and mechanical properties for dental applications.
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The sample size for the training set
- Not applicable. This is not an AI/ML device.
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How the ground truth for the training set was established
- Not applicable. This is not an AI/ML device.
§ 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.)