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Straumann® Variobase® Abutments: The Straumann® Variobase® abutments are prosthetic components 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. 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. Temporary restorations are indicated to be placed out of occlusion. Final abutments and restorations may be placed into occlusion when the implant is fully osseointegrated. All digitally designed copings and/or crowns for use with the Straumann® Variobase® Abutment system are intended to be sent to Straumann for manufacturing by a validated milling center.

Straumann® nice® Zirconia discs: Once finalized into a suitable design: n!ce® Zirconia LT and n!ce® Zirconia HT restorations are indicated for inlays, onlays, veneers, crowns, and bridges up to full arch. n!ce® Zirconia XT restorations are indicated for inlays, onlays, veneers, crowns, and bridges up to 3 units.

The purpose of this bundled premarket notification is to obtain regulatory clearance for the Straumann subject devices: Straumann® Variobase® Abutments (NHA) A two-piece abutment consisting of a Variobase (bottom half) and ceramic component (top half), Straumann® n!ce® Zirconia discs (EIH). Straumann® Variobase® Abutments are two-piece abutments. The Variobase is the bottom half of the two-piece abutment. The top half of the two-piece abutment is a CAD/CAM designed and manufactured ceramic component milled from Straumann n!ce Zirconia (ZrQ2), also subject to this submission as a material suitable for fabrication of the coping or crown that, when bonded to the previously cleared Variobase abutment base, forms a finished dental prosthesis. All digitally designed ceramic components for use with the Straumann Variobase abutments are intended to be sent to Straumann for manufacture at a validated milling center. The following materials are available within the digital workflow for the manufacturing of dental prosthetic restorations: (i) low translucency (LT), (ii) high translucency (HT), and (iii) extra high translucency (XT) n!ce Zirconia. The materials come in various shades (excluding White). Straumann Variobase abutments are available to interface with the following Straumann dental implant platforms: Regular Neck (RN), Wide Neck (WN), Regular CrossFit (RC), Wide Base (WB), Regular Base (RB), Narrow TorcFit (NT), Regular TorcFit (RT), Wide TorcFit (WT) and were previously cleared (K120822, K170356, K190082 and K200586). Straumann® n!ce® Zirconia discs are intended to be milled to produce prosthetic restorations for prepared natural teeth and endosseous dental implant abutments. The material is suitable for use in inlays, onlays, veneers, copings, crowns, and multi-unit restorations. Straumann n!ce Zirconia (ZrO2) discs will be offered in 3 translucencies: low translucency (LT), high translucency (HT) and extra high translucency (XT).

The provided text is a 510(k) summary for Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discs. It describes the device, its intended use, and compares its technological characteristics and performance to predicate and reference devices to demonstrate substantial equivalence.

However, the document does not describe a study involving a device that uses AI, nor does it discuss acceptance criteria and performance in the way typically expected for an AI/ML medical device submission (e.g., in terms of metrics like sensitivity, specificity, AUC, etc., or human reader performance with and without AI assistance). The "performance testing" section refers to mechanical and material testing (dynamic fatigue, static strength, biocompatibility, sterilization, flexural strength, chemical solubility, CTE, shrinkage factor) to demonstrate that the dental components meet established physical and biological standards.

Therefore, I cannot answer the questions about AI device performance, sample sizes for test sets, expert ground truth adjudication, MRMC studies, or training set details as this information is not present in the provided document.

Assuming this question is posed in the context of an AI/ML medical device, and the provided document is a misunderstanding, I will state explicitly that the document does not contain the requested information regarding AI device performance.

If the question implies that the dental devices themselves are the "device" in question and that their "acceptance criteria" pertain to their physical and material properties, then I can extract some relevant information as follows, though it won't perfectly match the structure of AI/ML device performance reporting.

Based on the provided text, the "device" refers to Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discs, which are physical dental prosthetics and materials, not an AI/ML medical device. Therefore, the acceptance criteria and study descriptions do not involve AI performance metrics or human reader studies.

The acceptance criteria are primarily related to biocompatibility, mechanical strength, and material properties as per established international standards for dental materials and implants. The "study that proves the device meets the acceptance criteria" refers to non-clinical performance testing of these physical properties.

Here's an interpretation based on the document's content, tailored to the questions where applicable, but noting the absence of AI/ML-specific details:

1. Table of Acceptance Criteria and Reported Device Performance

For the Straumann® n!ce® Zirconia discs, key mechanical properties are compared to predicate devices, and these represent the performance thresholds that align with ISO 6872 standards. The document implicitly states that the Straumann® Variobase® Abutments also met relevant standards (ISO 14801).

For Straumann® Variobase® Abutments, the document states that "Dynamic fatigue and static strength tests were conducted according to ISO 14801 and the FDA guidance document... and demonstrated the two-piece Straumann Variobase Abutments with Straumann n!ce Zirconia are equivalent to the primary predicate and reference devices." This implies meeting the strength and fatigue requirements of these standards.

Biocompatibility for both devices was confirmed with chemical characterization and in-vitro cytotoxicity testing according to ISO 10993-5, 10993-12, and 10993-18.

Sterilization process for the Abutments was validated according to ISO 17665-1, ISO 17665-2, and applicable FDA guidance.

2. Sample size used for the test set and the data provenance
The document does not specify exact sample sizes for the mechanical and biological "test sets." It refers to "tests" and "evaluations" that meet ISO standards, which inherently include sample size requirements, but these are not enumerated.
Data provenance is implicitly "non-clinical laboratory testing" by the manufacturer, or a validated testing partner. It is not patient data (retrospective or prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth for these studies is based on objective, standardized physical, chemical, and biological measurements performed in a laboratory, not expert human interpretation (like in imaging studies).

4. Adjudication method for the test set
Not applicable, as ground truth is established by objective measurements against ISO standards.

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 not an AI/ML device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device.

7. The type of ground truth used
The ground truth used for these dental devices is based on established international standards (e.g., ISO 6872, ISO 14801, ISO 10993 series) for material properties, mechanical performance, and biocompatibility. This includes objective measurements of flexural strength, chemical composition, thickness, and results from in-vitro cytotoxicity tests.

8. The sample size for the training set
Not applicable. There is no concept of a "training set" for physical product testing in this context, as it's not an AI/ML device.

9. How the ground truth for the training set was established
Not applicable.

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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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