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CEREC Guides are intended to support the dentist or oral surgeon when drilling for placement of dental implants. CEREC Guides are intended to be designed and fabricated using the Sirona Dental CAD/CAM System's CEREC Chairside software and CAM equipment, Galileos Implant dental implant planning software, and Calibra Universal Self-Adhesive Resin Cement.

The CEREC Guide dental surgical guides are milled poly(methyl methacrylate) [PMMA] devices which are designed and fabricated utilizing the Sirona Dental CAD/CAM System with CEREC Chairside Software (K181520) and are intended to act only as dental implant placement templates. The CEREC Guides are designed in the Sirona Dental CAD/CAM System's CEREC Chairside Software utilizing, as an input, a completed dental implant treatment plan which is developed in the "Galileos Implant treatment planning software as cleared under premarket notification K093090.

The CEREC Guide surgical guides are offered in two variants, the CEREC Guide 2 and CEREC Guide 3. Both the CEREC Guide 2 and CEREC Guide 3 are milled from the CEREC Guide Bloc milling blocks. The CEREC Guide Blocs are clear, PMMA blocks intended for milling utilizing the CEREC MC XL family of milling units. CEREC Guide Blocs are offered in two size variants, "medi" and "maxi".

The CEREC Guide 2 surgical guides consist of the surgical guide body milled from the CEREC Guide Bloc PMMA milling blocks. The CEREC Guide 2 surgical guides are used in conjunction with CEREC Guide Drill Keys. CEREC Guide Drill Keys are stainless steel, reusable drill guide instruments which are offered in variants with internal diameters ranging from 2.0 mm to 4.85 mm.

The CEREC Guide 3 surgical guides consist of the CAD/CAM surgical guide body milled from the CEREC Guide Bloc PMMA milling blocks. CEREC Guide 3 surgical guides feature integral titanium guide sleeves that are bonded the CEREC Guide 3 surgical guide body using Dentsply Sirona Calibra® Universal adhesive (K073173). The CEREC Guide 3 Guide Sleeves are single use and are offered in 4 size variants, with outer diameters ranging from 5.5 mm to 6.0 mm, and internal diameters ranging from 4.48 mm - 5.2 mm.

The provided FDA 510(k) premarket notification for "CEREC Guides" focuses on demonstrating substantial equivalence to a predicate device ("SIMPLANT Guide," K170849) through non-clinical performance data. It does not involve a multi-reader multi-case (MRMC) study or artificial intelligence (AI) performance evaluation. Therefore, many of the requested elements for an AI-based device, such as ground truth establishment by experts, adjudication methods, and MRMC study details, are not applicable here.

Here's a breakdown of the available information relevant to acceptance criteria and study proving device performance:

1. A table of acceptance criteria and the reported device performance

The document does not present a formal table of acceptance criteria with specific numerical thresholds and corresponding performance results in the format requested, typical for AI/ML device submissions. Instead, it describes various non-clinical tests conducted to support substantial equivalence. The "acceptance criteria" are implied by the successful completion of these validation tests.

2. Sample size used for the test set and the data provenance

The document describes non-clinical bench and validation tests rather than a test set of patient data. Specific sample sizes for these engineering and material tests (e.g., number of guides milled for accuracy, number of drill sleeves tested for retention) are not detailed in this summary. The data provenance is from the manufacturer's internal testing as part of the regulatory submission process.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This submission relies on non-clinical engineering and performance testing, not on interpretative performance (like image reading) where expert ground truth is typically established. The "ground truth" for the device's function is its design specifications and physical properties, tested through controlled experiments.

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

Not applicable. There's no human adjudication process described, as it's not a study evaluating human interpretation or AI output against a consensus.

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 MRMC study was done. This device, CEREC Guides, is a physical, milled surgical guide, not an AI or software-assisted diagnostic tool that would typically undergo an MRMC study to assess reader performance. The submission explicitly states: "No human clinical data was included in this premarket notification to support the substantial equivalence of the subject CEREC Guides."

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

Not applicable. This is not an AI algorithm. Its performance is evaluated based on its physical properties, manufacturing accuracy, and integration with existing approved software and hardware. The "device" itself is the physical CEREC Guide.

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

The "ground truth" for the performance tests is based on:

• Design Specifications and Reference Standards: The intended design dimensions and functionalities derived from the Galileos Implant treatment planning software served as the reference for accuracy testing.
• Established Material Properties and Biocompatibility Standards: ISO standards (e.g., ISO 10477, ISO 10993-1) and published literature for material strength and biocompatibility served as the benchmark.
• Validated Disinfection Protocols: FDA and industry guidelines for high-level disinfection processes.

8. The sample size for the training set

Not applicable. This device is not an AI/ML model that requires a training set.

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

Not applicable. As there is no AI/ML model, there is no training set or associated ground truth establishment for a training set.

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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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