(219 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.
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 using either a burnout coping or STL model for open CAD software. The coping and/or crown would be manufactured via validated Straumann milling.
The provided text describes a 510(k) submission for Straumann® Variobase™ Abutments, detailing the device, its intended use, and performance testing. However, it does not include the specific acceptance criteria or the full study details needed to populate all sections of your request comprehensively. The text primarily focuses on bench testing for fatigue limits and establishing substantial equivalence to predicate devices, rather than a clinical study evaluating diagnostic performance against defined acceptance criteria.
Based on the provided document, here's what can be extracted and what information is missing:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not Explicitly Stated for diagnostic metrics. The document mentions "requirements of ISO 5832-11" for material and evaluation of "fatigue load limits" in accordance with "FDA guidance document 'Guidance for Industry and FDA Staff – Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments'". These are performance standards for mechanical properties, not diagnostic accuracy. | Not Explicitly Stated for diagnostic metrics. The study focused on evaluating "fatigue load limits" of the abutments and confirming the material meets ISO 5832-11. The document concludes "the Straumann® Variobase" Abutments are substantially equivalent to the predicate devices and do not pose new issues of safety and effectiveness when used as labeled." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not applicable in the context of diagnostic performance as described. The testing involved mechanical bench testing of components (Polycon® ae and Zerion®) rather than a test set of patient data.
- Data Provenance: Not applicable. The tests were bench tests conducted on device components, not on patient data.
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. This was a mechanical performance study, not a study requiring expert-established ground truth for diagnostic accuracy.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This was a mechanical performance study.
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
- No. This is a traditional 510(k) for a dental abutment, focusing on material and mechanical properties, not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. Not an AI diagnostic device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not applicable in the context of diagnostic performance. For the mechanical testing, the "ground truth" would be established by the engineering standards and test methodology (e.g., ISO 5832-11 and FDA guidance for fatigue testing), rather than clinical ground truth.
8. The sample size for the training set
- Not applicable. This is not an AI/machine learning device.
9. How the ground truth for the training set was established
- Not applicable. This is not an AI/machine learning device.
Summary of what is described in the 510(k):
The submission describes the Straumann® Variobase™ Abutments as pre-manufactured (stock) abutments made from a titanium-aluminum-niobium alloy (meeting ISO 5832-11). Performance testing involved bench testing to evaluate the fatigue load limits in accordance with FDA guidance for Class II dental implants and abutments. This testing was to demonstrate substantial equivalence to predicate devices (K120822 and K111935) and confirm that the device does not pose new safety or effectiveness issues. The materials for the coping/crown component were also identical to predicate devices. The focus is on the mechanical and material properties of the abutment to support prosthetic restorations.
§ 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.)