(73 days)
Nobel Biocare's AurAdapt™ Abutment System is a set of screw retained modifiable gold alloy abutments that are secured to an endosseous implant and are intended to function as an anchor to which prosthetic devices, such as artificial teeth, may be attached by a screw or by dental cement to restore a patient's chewing function.
The Nobel Biocare AurAdapt™ Abutment System is a set of modifiable gold alloy abutments which are secured directly to the dental fixtures using a gold abutment screw. These abutments (also referred to as "Gold Cylinder to Fixture" abutments) can be casted into a screw retained dental prosthesis or reshaped by wax-up techniques to anchor a cemented prosthesis. When more than one of the modifiable abutments are used, a multi-unit bridge can be attached to the abutments.
This pre-market notification for the Nobel Biocare AurAdapt™ Abutment System does not contain the detailed information necessary to complete all sections of your request. This document is a 510(k) summary submitted to the FDA in 1997 for a medical device (dental abutment system) and focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a performance study with acceptance criteria in the way you've outlined for an AI/software device.
Here's an attempt to answer the questions based on the provided text, along with explanations for why certain information is absent:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Not Explicitly Stated) | Reported Device Performance (Implied from Substantial Equivalence and Safety Concerns) |
|---|---|
| Functional Equivalence: Device performs as an anchor for prosthetic devices to restore chewing function. | "The technological characteristics between the components of the AurAdapt Abutment System and the corresponding predicate products found in the Branemark System® are identical." (Implies similar functional performance). However, no specific performance metrics (e.g., success rates, failure rates) are provided. |
| Material Compatibility: Gold alloy abutments are suitable for use in the oral cavity and interface with titanium implants. | Implied by "modifiable gold alloy abutments" and "secured directly to the dental fixtures." No specific material compatibility test results are presented. |
| Mechanical Integrity (Screws): Abutment screws remain secure under masticatory forces and avoid fracture. | Safety Concern Identified: "occasional fractures of the screw attaching the abutment to the fixtures usually due to functional overload from masticastory forces" and "loose (usually because torque force below recommended values was applied...)" (This indicates areas where performance could be compromised, but no established acceptance criteria or empirical performance data is given for the new device against these concerns). |
| Proper Seating: Abutments seat correctly without causing inflammation. | Safety Concern Identified: "improper seating of abutments resulting in gingival initial inflammation and fistulae formation." (Again, a concern, not an acceptance criterion with associated performance data for the new device). |
| Biocompatibility: Materials are biocompatible. | Not explicitly stated, but assumed for dental devices. No specific biocompatibility study results are mentioned. |
Explanation for Table: The document's primary purpose is to establish substantial equivalence. It highlights the intended use and technological characteristics being identical to predicate devices. It then lists "Safety and Effectiveness Concerns" encountered with similar abutment systems, which represent potential failure modes but are not presented as acceptance criteria for the new device, nor is there corresponding performance data for how the AurAdapt™ Abutment System specifically addresses or performs against these concerns. This type of submission does not typically include a detailed performance study with explicit acceptance criteria and corresponding results in the format you've requested.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not Applicable. The document does not describe a performance study with a test set of data in the context of an AI/software device. It's a submission for a physical medical device.
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. See point 2. No test set requiring expert ground truth is described.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not Applicable. See point 2.
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. This device is a physical dental abutment system, not an AI or imaging diagnostic tool that would typically undergo MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable. See point 2.
8. The sample size for the training set
- Not Applicable. This is a physical device, not an AI or software algorithm that uses a training set.
9. How the ground truth for the training set was established
- Not Applicable. See point 8.
§ 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.)