(98 days)
The Straumann® Variobase™ Abutment is a titanium base placed onto Straumann dental implants to provide support for customized prosthetic restorations. Straumann® Variobase™ Abutments are indicated for screw-retained single tooth or cement-retained single tooth and bridge restorations. All digitally designed copings and/or crowns for use with the Straumann® Variobase™ Abutment system are intended to be sent to Straumann for manufacture at a validated milling center.
The Straumann® Variobase™ Abutments are pre-manufactured (stock) abutments, sometimes referred to as "Ti-bases". Straumann® Variobase" Abutments are available to fit Straumann® dental implant platforms NNC (Narrow Neck CrossFit®), RN (Regular Neck), WN (Wide Neck), NC (Narrow CrossFit®), and RC (Regular CrossFit®). A dental laboratory technician would design the corresponding coping and/or crown (the second component of the Variobase two-piece abutment) and/or prosthetic restoration in the dental laboratory via their preferred workflow for pressing, or milling using either a burnout coping or STL model for open CAD software. The coping and/or crown would be manufactured via traditional laboratory methods for pressing or casting, or via validated Straumann milling.
The purpose of this submission is to add coping and/or crown materials to the Straumann® Variobase™ Abutment portfolio for the previously cleared validated Straumann milling workflow and to expand the design/manufacturing workflow to include in-lab pressing and casting techniques and materials.
The provided text describes Straumann Variobase Abutments and their substantial equivalence to predicate devices, but it does not contain the detailed study information, acceptance criteria, or performance data typically found in a clinical study report.
The document specifically states under section "5.8 Performance Testing": "Bench testing was performed with each coping/crown material to evaluate the performance of the proposed Straumann® Variobase™ Abutments. Dynamic fatigue tests were conducted in according to the FDA guidance document 'Guidance for Industry and FDA Staff – Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments'."
This indicates that bench testing was performed, but the results, specific acceptance criteria, sample sizes, and other detailed information requested are not present in this 510(k) summary document. Without this information, I cannot fulfill all parts of your request.
However, I can extract the information that is present:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: While specific numerical acceptance criteria are not presented in this document, the general criterion is that the device must meet the requirements of the FDA guidance document "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments" through dynamic fatigue tests. The overall conclusion is that the device is "substantially equivalent to the predicate devices and do not pose new issues of safety and effectiveness."
- Reported Device Performance: The document states that "Bench testing was performed with each coping/crown material to evaluate the performance of the proposed Straumann® Variobase™ Abutments." No quantitative performance metrics (e.g., fatigue strength, cycles to failure) are provided in this summary.
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified in the provided text.
- Data Provenance: The document refers to "Bench testing," which is typically laboratory-based. The location or specific origin of this data (e.g., country) is not mentioned. It is by nature retrospective for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not specified. This was bench testing, not a clinical study involving experts establishing ground truth for a test set in the conventional sense of diagnostic device evaluation.
4. Adjudication method for the test set:
- Not applicable/Not specified. This was bench testing.
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 is a submission for dental abutments, not an AI/diagnostic imaging device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is for dental abutments, not a standalone algorithm.
7. The type of ground truth used:
- For the bench testing, "ground truth" would be established by the physical testing methods and engineering standards outlined in the FDA guidance document for dynamic fatigue tests. This is a form of physical measurement/engineering standard rather than clinical ground truth (e.g., pathology).
8. The sample size for the training set:
- Not applicable. This document describes bench testing for structural integrity of a medical device, not a machine learning model that requires a "training set."
9. How the ground truth for the training set was established:
- Not applicable. (No training set for an AI model).
§ 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.)