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The Straumann® CARES® Variobase™ Abutment is a two-piece dental abutment consisting of the Straumann® Variobase™ Abutment and the Straumann® CARES® Variobase™ Coping which is intended to be placed onto Straumann dental implants to provide support for prosthetic reconstruction such as crowns and bridges. Straumann® CARES® Variobase™ Abutments are indicated for screw-retained single tooth and bridge restorations.

The Straumann® CARES® Variobase™ Coping polycon® ae in combination with the Straumann® Variobase™ Abutment is indicated for temporary (up to 180 days) dental restoration of a Straumann dental implant.

The Straumann® CARES® Variobase™ portfolio consists of different parts which are used to provide prosthetic rehabilitation of a dental implant.

Premanufactured Variobase™ Abutments are available for the different platforms of the Straumann® dental implant system. These serve as a bonding base to which a patientspecific coping can be cemented. The coping can be made from ceramics to result in a permanent restoration, or made from acrylics to result in a temporary restoration (up to 180 davs).

The coping can be fully anatomical, i.e. it is a replica of a tooth with incisal edge or occlusal surface. It may also be of a reduced tooth shape in which case a separate crown needs to be cemented onto the coping or direct veneering needs to be applied.

Straumann® Variobase™ Abutments are bonding bases made from a titanium-aluminumniobium alloy. They are standard medical devices (stock produced).

Straumann® CARES® Variobase™ Copings is patient-specific medical devices, i.e. they are designed for an individual patient.

Straumann® CARES® Variobase™ Copings are designed either by a wax-up or a "CADup" procedure. Either way is processed through Straumann's CAD system consisting of the table top 3D-scanner Straumann® CARES® Scan CS2 and the corresponding CAD software Straumann® CARES® Visual. (CAD: Computer Aided Design)

In a wax-up procedure a wax model of a coping is created and scanned to be able to CAM produce the coping from a selected material. (CAM: Computer Aided Manufacturing)

In a "CAD-up" procedure, scanned data is used as the source to digitally design a coping. The design data is then sent to a Straumann milling center. The Straumann® CARES® Variobase™ Copings are CAM produced at the Straumann milling center according to the design file received and from the selected material.

The provided text describes the 510(k) premarket notification for "Straumann® CARES® Variobase™ Abutments." Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: The document mentions "Bench testing was performed to evaluate the fatigue load limits" and "Dynamic fatique tests were carried out," but it does not specify the exact sample size (number of abutments/copings tested).
• Data Provenance: The tests were conducted internally by Straumann AG as part of their 510(k) submission. The document does not explicitly state the country of origin of the data beyond "Institut Straumann AG Peter Merian-Weg 12 CH-4052 Basel Switzerland." The study is prospective in the sense that the testing was performed specifically to evaluate this device for regulatory submission.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

This device appears to be a physical dental prosthetic component. The acceptance criteria and performance evaluation are based on engineering and material science standards (e.g., ISO for materials, FDA Guidance for dynamic fatigue tests), rather than qualitative assessment of images or clinical outcomes by human experts on a 'test set' in the way one might evaluate AI performance for medical imaging. Therefore, the concept of "experts used to establish ground truth" with specific qualifications for a test set, as applied to AI/imaging studies, is not applicable here. The ground truth for mechanical testing is derived from established engineering test protocols and performance metrics.

4. Adjudication Method for the Test Set

As explained in point 3, the evaluation of this device involves bench testing against predefined engineering standards. An "adjudication method" involving multiple human readers (e.g., 2+1, 3+1) is not applicable for this type of performance testing. The results are quantitative measurements against established pass/fail criteria.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This type of study typically assesses the performance of human readers, with and without AI assistance, on a set of cases. The submission focuses on the mechanical and material performance of a dental prosthetic device, not on diagnostic accuracy involving human interpretation of clinical cases.

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

While the device involves CAD/CAM software ("Straumann® CARES® Visual"), the performance testing described is for the physical prosthetic components (abutments and copings) rather than the standalone performance of an algorithm to, for example, diagnose a condition or predict an outcome. The CAD software's validation ensures it can design prosthetics that meet specifications, but this is a different type of "standalone performance" than an AI algorithm in a diagnostic context. The core performance testing here is physical bench testing of the device itself.

7. The Type of Ground Truth Used

The ground truth used for evaluating the device's performance is based on:

• Established engineering standards and guidance documents: Specifically, "FDA's Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments" for dynamic fatigue tests and "ISO 5832-11" for material properties.
• Pre-defined acceptance criteria: These criteria are derived from the aforementioned standards, specifying the thresholds for parameters like fatigue load limits.

8. The Sample Size for the Training Set

This product is a physical dental prosthetic, not an AI algorithm trained on a dataset. Therefore, the concept of a "training set" in the context of machine learning is not applicable. The CAD/CAM software itself would have been developed and validated through its own processes, but details regarding a "training set" for that software are not provided in this document as it pertains to the physical device's performance testing.

9. How the Ground Truth for the Training Set was Established

As stated in point 8, the concept of a "training set" for this physical device is not applicable. For the CAD software, while not explicitly detailed for this product, ground truth for CAD/CAM systems is typically established through:

• Engineering specifications and tolerances: Defining the precise dimensions, shapes, and material properties required for the designed components.
• Physical prototypes and verification: Creating and testing physical models to ensure they match the digital design and meet functional requirements.
• Industry standards and clinical requirements: Ensuring the digital designs conform to established norms for dental prosthetics.

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