Search Results

The Straumann CARES® TAN abutments are indicated for single tooth replacement and multiple tooth restorations. The prosthetic restoration can be cemented or directly veneered/ screw-retained.

Straumann® CARES® TAN Abutments are used for the restoration of Straumann dental implants of different types, endosteal diameters, lengths. The abutments are available with interface geometry compatible with the bone level NC (3.3 mm) and RC (4.1 mm) and the tissue level RN (3.3 mm, 4.1 mm) and WN (4.8 mm) implants. The proposed CARES® TAN abutments are provided in a set that contains the individualized abutment and a corresponding basal screw. The Straumann CARES TAN Abutments allow for individual customization regarding function and esthetics. Straumann CARES TAN Abutments are designed by the customer either by means of a traditional wax-up abutment that is subsequently scanned or by scanning of the intraoral situation and designing of the shape by using software such as Straumann CARES Visual. The design data is then transferred to Straumann where the fabrication of the customized abutment is carried out.

The document describes a 510(k) premarket notification for Straumann® CARES® Titanium Alloy (TAN) Abutments. This submission focuses on demonstrating substantial equivalence to previously marketed predicate devices, rather than proving the device meets acceptance criteria through a clinical study. Therefore, most of the requested information regarding study design for proving acceptance criteria is not directly applicable.

Here's an analysis of the provided information:

1. Table of acceptance criteria and the reported device performance

The document does not explicitly present a table of acceptance criteria with corresponding performance data in the typical sense of a clinical trial. Instead, it details design limits for the abutments and then provides a list of bench studies conducted to demonstrate the device's performance characteristics. The "Equivalence Discussion" column in the "Technological Characteristics" table also serves as a comparison to predicate devices, inferring acceptance based on similarity or acceptable differences.

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 refers to bench studies. For such studies, the "sample size" typically refers to the number of test specimens. However, the specific sample sizes for the dynamic fatigue, veneer, and corrosion resistance tests are not provided in this summary. The provenance of the data is not explicitly stated in terms of country of origin or whether it was retrospective or prospective, beyond being "bench studies."

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 as the submission is based on bench studies and a comparison to predicate devices, not on a clinical study requiring expert ground truth for a test set of patient data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable for the same reasons as point 3.

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 information is not applicable as the device is a dental abutment, not an AI-powered diagnostic or assistive tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This information is not applicable as the device is a physical medical device (dental abutment), not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the bench studies, the "ground truth" would be established by the standardized test methods themselves (e.g., ISO 14801 for dynamic fatigue, ISO 9693-1 for veneer testing, ISO 10271 for corrosion resistance, ISO 10993 for biocompatibility). These international standards define the accepted methods and performance metrics for evaluating such devices. There is no mention of expert consensus, pathology, or outcomes data in the context of establishing ground truth for the performance evaluations.

8. The sample size for the training set

This information is not applicable as there is no training set in the context of this device's evaluation (it's not an AI/machine learning device).

9. How the ground truth for the training set was established

This information is not applicable for the same reasons as point 8.

Ask a specific question about this device