(96 days)
Straumann® Variobase™ prosthetic components directly connected to the endosseous dental implants are indicated for use as an aid in prosthetic rehabilitations. The prosthetic restoration (bridge or over-denture) can be cemented on the Straumann® Variobase™ prosthetic components. A temporary restoration can be used prior to the insertion of the final components to maintain, stabilize and form the soft tissue during the healing phase. They may not be placed into occlusion. Final abutments and restorations may be placed into occlusion when the implant is fully osseointegrated.
Straumann® Variobase® abutments are intended to be placed into Straumann dental implants to provide support for prosthetic reconstructions such as bridges and over-dentures.
The Straumann Variobase Abutments for Bars & Bridges are non-engaging abutments made from Ti-6Al-7Nb (TAN) that support a bridge or bar reconstruction (framework or full contour) on two or more dental implants. The corresponding basal screw is delivered with the abutment for connecting the abutment to the implant. A dental laboratory technician designs and manufactures the bridge/bar reconstruction via their preferred workflow using traditional or CAD/CAM methods.
The provided text is a 510(k) Summary for the Straumann® Variobase® Abutment for Bridges/Bars. It outlines the characteristics of the device and its substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a specific study proving the device meets those criteria in the typical sense of a diagnostic or clinical performance study.
Instead, the "study" referred to is a bench study focused on mechanical performance and material characteristics to demonstrate substantial equivalence to legally marketed predicate devices, rather than a clinical study evaluating diagnostic accuracy or effectiveness.
Here's a breakdown of the requested information based on the provided text, highlighting what is available and what is not:
1. A table of acceptance criteria and the reported device performance
The document doesn't present explicit "acceptance criteria" in a quantitative, pass/fail table for clinical performance. Instead, it discusses "equivalence" based on various features and a dynamic fatigue test.
| Feature/Characteristic | Acceptance Criteria (Implied by Equivalence) | Reported Device Performance |
|---|---|---|
| Indications for Use | Within the scope of the predicate devices. | "The basic indication of providing support for prostheses is identical. Where the predicate is indicated for both single-unit and multi-unit restorations, the subject devices are only suitable for multi-unit restorations. This limited indication is within the scope of the indication of the predicate devices." (Equivalent) |
| Abutment Material | Identical to predicate device material (Titanium-Aluminum-Niobium alloy (Ti-6Al-7Nb)). | "Titanium-Aluminum-Niobium alloy (Ti-6Al-7Nb)" (Identical) |
| Abutment Diameter | Within the range of predicate device diameters. | "Subject device diameters are within the range of diameters for the predicate device." (Subject: 4.2 - 7.0 mm, Predicate: 3.8 - 7.0 mm) (Equivalent) |
| Abutment Height | Same minimum height as predicate; taller variants' performance addressed via bench testing. | "The subject devices have the same minimum height as the Variobase predicates. Performance of the taller subject device is addressed via bench testing." (Subject: 3.5 – 5.2 mm, Predicate: 3.5 – 4.5 mm) (Equivalent) |
| Abutment Apical Design | Morse taper portion identical to predicate; non-engaging feature for multi-unit restorations. | "The Morse taper portion of both the subject and Variobase predicate devices are identical. Non-engaging abutments are necessary so as not to introduce mechanical constraints in the framework that would affect fit." (Equivalent) |
| Abutment Coronal Design | Conic taper within the range established by reference predicates. | "The conic taper of the subject devices is within the range established by the synOcta and Multibase predicates." (Equivalent) |
| Restoration Material | Within the scope of materials indicated for the predicate devices. | "The range of materials cleared for use with the predicate devices is within the scope of materials indicated for the subject devices." (Equivalent) |
| Design/Manufacturing Workflow | Identical to predicate. | "Identical" |
| Mode of Attachment | Identical to predicate (Screw-retained or cement retained). | "Identical" |
| Reusable | Identical to predicate (No). | "Identical" |
| Dynamic Fatigue | Satisfactorily addressed via bench studies and consistent with FDA guidance and ISO 14801. (Implied: Device must meet or exceed performance of predicate or relevant standards.) | "Dynamic fatigue test data consistent with FDA guidance and ISO 14801 have been referenced in support of this submission." This indicates the device passed these structural integrity tests relevant to dental implants and abutments. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document primarily relies on bench testing for dynamic fatigue. It doesn't specify a sample size for this testing other than "data have been referenced." No information is provided about data provenance ( країни of origin or retrospective/prospective nature) as it's not a clinical data study.
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)
This information is not applicable here because the "test set" refers to physical samples for mechanical testing (dynamic fatigue), not a dataset for a diagnostic algorithm where expert ground truth would be established.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. Adjudication methods are typically used for establishing ground truth in clinical or image-based studies, not for mechanical 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
This is not applicable. The device is an endosseous dental implant abutment, a physical component, not an AI or diagnostic tool. Therefore, MRMC studies and AI assistance comparisons are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is a physical medical device, not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" in this context is the mechanical performance standards (e.g., ISO 14801 for dynamic fatigue) and the material properties of the device, which are evaluated through bench testing. There is no biological or diagnostic "ground truth" from human subjects involved in this 510(k) submission for mechanical equivalence.
8. The sample size for the training set
This is not applicable. There is no "training set" as this is not a machine learning or AI-based device.
9. How the ground truth for the training set was established
This is not applicable for the same reason as 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.)