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The Straumann® Variobase® for CEREC® are titanium alloy abutments placed onto Straumann dental implants to provide support for customized prosthetic restorations. Straumann® Variobase® for CEREC® abutments are indicated for screw-retained single tooth or cement-retained single tooth and bridge restorations.

All digitally designed copings and/or crowns for use with the Straumann® Variobase® for CEREC® abutments are to be designed using Sirona inLab software (Version 3.65 or higher) or Sirona CEREC Software (Version 4.2 or higher) and manufactured using a Sirona CEREC or inLab MC X or MC XL milling unit.

The Straumann® Variobase® for CEREC® abutments provide the interface for copings or crowns designed and milled using the Sirona CEREC system with four of the Straumann dental implant platforms: RN (Reqular Neck), WN (Wide Neck), RC (Regular CrossFit®), and NC (Narrow CrossFit®). The Straumann® Variobase® for CEREC® abutments are pre-manufactured (stock) abutments, sometimes referred to as "Ti-bases," made from a titanium-aluminum-niobium (TAN) alloy. The coronal portion is designed to interface with the pre-machined mounting hole in the milling blanks compatible with the Sirona CEREC MC X and MC XL prosthetic milling systems, and the base portion is available in four models to fit the four Straumann® dental implant platforms listed above.

The provided text is a 510(k) summary for the Straumann® Variobase® for CEREC® abutments. It details the device, its intended use, and comparative analysis with predicate devices, along with performance testing conducted to demonstrate substantial equivalence.

Here's an analysis of the acceptance criteria and study information provided (or absence thereof):

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a formal table of explicit, pre-defined acceptance criteria with corresponding performance metrics like sensitivity, specificity, or accuracy, which are common for AI/diagnostic devices. Instead, it demonstrates "substantial equivalence" to predicate devices through various performance tests.

Here's what can be inferred about the performance goals and the results reported:

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

The document does not explicitly state sample sizes for specific tests in terms of number of cases, patients, or data points in a way that would be typical for an AI-driven diagnostic.

• Dimensional verification: "CEREC® e.max blocks" are mentioned, implying physical components were tested, but no number is given.
• Dynamic fatigue testing: "Worst case dynamic fatigue testing" is mentioned, implying a specific test methodology, but the sample size (e.g., number of abutments tested) is not provided.
• Process validation: Relates to the workflow, not a data set.
• Sterilization validation: Refers to compliance with standards, not performance on a data set.

The provenance of data is not applicable in the context of this device, as it's a dental implant abutment, not a data-driven diagnostic or AI device. The testing focuses on physical and functional characteristics.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable. The device is a physical dental hardware component (abutment) and its compatibility with a CAD/CAM system, not an AI or diagnostic application requiring expert review for ground truth establishment. The "ground truth" for the performance tests would be objective measurement standards (e.g., ISO for sterilization, mechanical testing standards for fatigue).

4. Adjudication Method for the Test Set

This information is not applicable as the device is not an AI/diagnostic device. Performance tests involve objective measurements and adherence to standards, not subjective expert adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

This information is not applicable. The device is a physical medical device (dental abutment), not a diagnostic or AI system that human readers would interact with. Therefore, there's no "human readers with/without AI assistance" scenario.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This information is not applicable. The device is a physical component, not an algorithm. The "algorithm" aspect refers to the Sirona CAD/CAM software used to design the copings/crowns that interface with the abutment, and the document clarifies that the device (abutment) is compatible with existing, cleared software versions. The abutment itself does not perform any algorithmic function.

7. Type of Ground Truth Used

The "ground truth" for this device's performance testing consists of:

• Physical Fit Standards: For dimensional verification (e.g., CAD specifications, manufacturing tolerances).
• Mechanical Performance Standards: For dynamic fatigue testing (e.g., ISO standards for dental implants and prosthetics that define minimum required fatigue properties).
• Process Standards: For process validation (Sirona CEREC InLab workflow parameters).
• Sterilization Standards: For sterilization validation (ISO 17665-1, ISO/TR 17665-2, ANSI/AAMI ST79).

8. Sample Size for the Training Set

This information is not applicable. The device is a physical dental abutment, not an AI algorithm that requires a training set. The reference to Sirona software versions (3.65 and 4.2 or higher) indicates compatibility with existing, validated software, not training a new model.

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

This information is not applicable as there is no training set for this physical device.

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