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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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