(50 days)
TDS Zirconia 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 Zirconia Abutment for Nobel Biocare Branemark are zirconia abutments made of yttria-stabilized zircona (Y-TZP) designed to be used in conjunction with specific dental implants utilizing the TDS Abutment screw, which is made of Ti-6A1-4V ELI titanium and is used to secure the abutment to the implant. In combination with the implant, the abutments support single or multi-unit cement-retained restorations in the maxillary and/or mandibular arch. TDS Zirconia 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.
This looks like a 510(k) premarket notification for a dental implant abutment, not a study describing the acceptance criteria or performance of an AI medical device. This document focuses on demonstrating substantial equivalence to a predicate device for regulatory approval, rather than presenting clinical study data for an AI algorithm.
Therefore, most of the requested information regarding acceptance criteria, study design, expert involvement, and AI performance metrics cannot be extracted from this document.
Here's an assessment based on the provided text:
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A table of acceptance criteria and the reported device performance
- Not applicable. This document is for a physical medical device (dental abutment), not an AI algorithm. It focuses on demonstrating substantial equivalence to a predicate device, not performance against specific clinical acceptance criteria in a study.
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Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable. No test set or clinical data is presented for performance evaluation.
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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. No ground truth establishment for a test set is discussed.
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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 not an AI device.
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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 AI device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. No ground truth is discussed in the context of an AI algorithm evaluation.
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The sample size for the training set
- Not applicable. This is not an AI device that requires a training set.
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How the ground truth for the training set was established
- Not applicable.
In summary, the provided document is a regulatory submission for a dental implant abutment, a physical medical device. It does not contain information about AI algorithm performance, clinical studies, acceptance criteria, or ground truth establishment as would be relevant for an AI-based medical 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.)