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The Straumann® Variobase® C are titanium alloy abutments placed onto Straumann dental implants to provide support for customized prosthetic restorations. Straumann® Variobase® C 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® C abutments are to be designed using Sirona CEREC Software and manufactured using a Sirona CEREC or inLab MC X or MC XL milling unit.

The Straumann® Variobase® C abutments are two-piece abutments composed of the following components:

• . Straumann® Variobase® C (Ti-base)
• . Prosthetic Restoration (patient specific coping or crown)
• . Basal Screw

The Straumann® Variobase® C abutments provide the interface for copings or crowns designed and milled using a Sirona Dental CAD/CAM System with the Straumann dental implant platforms: RC (Regular CrossFit®), NC (Narrow CrossFit®), NNC (Narrow Neck CrossFit®), RB/WB(Regular Base/Wide Base), and WB (Wide Base). The Straumann® Variobase® C 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 MC XL prosthetic milling systems, and the base portion is available to fit the Straumann® dental implant platforms listed above. The top half materials that are compatible with the Straumann Variobase C abutments include IPS e.max CAD, inCoris ZI, and n!ce. The top half material compatibility is dependent on the dental implant platform, with inCoris Zl and n!ce only being compatible with the RC (Regular CrossFit®) and NC (Narrow CrossFit®) platforms.

The provided text describes a 510(k) premarket notification for a dental device, the "Straumann® Variobase® C." It details the device's characteristics, intended use, indications for use, and a comparison to predicate devices. The section titled "Performance Testing 1.8" provides information on the studies conducted to demonstrate the device meets acceptance criteria.

Here's an analysis of the provided information against your requested criteria:

Based on the provided text, there is no information related to an AI/ML-based medical device performance study. The device described, Straumann® Variobase® C, is a dental abutment, which is a physical component used with dental implants. The performance testing mentioned (Dynamic fatigue and static strength tests, biocompatibility, sterilization process) are standard pre-market tests for physical medical devices and do not involve AI/ML.

Therefore, I cannot fulfill your request for details on:

1. A table of acceptance criteria and reported device performance (for AI/ML): The document doesn't provide this for an AI/ML device. The performance tests are for mechanical properties and sterility.
2. Sample sizes used for the test set and data provenance: Not applicable in the context of AI/ML. The provided text refers to physical testing (e.g., fatigue tests, which would have sample sizes for individual abutments).
3. Number of experts used to establish ground truth and qualifications: Not applicable, as there's no AI/ML model requiring ground truth from experts. The software mentioned (Sirona CEREC Software) is a CAD/CAM design software, not an AI diagnostic tool.
4. Adjudication method for the test set: Not applicable.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not done, as there's no AI component for human readers to interact with.
6. Standalone (algorithm only without human-in-the-loop performance): Not applicable.
7. Type of ground truth used: Not applicable.
8. Sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

Summary of relevant information from the document (not AI/ML related):

• Device Type: Endosseous Dental Implant Abutment (physical component)
• Performance Tests Mentioned:
  • Dynamic fatigue and static strength tests (according to ISO 14801:2016 and FDA guidance document "Guidance for Industry and FDA Staff – Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments").
  • Biocompatibility (stated that materials are identical to predicate, so no new issues).
  • Sterilization process validation (according to FDA guidance "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling" and ISO 17665-1, ISO 17665-2).
• Conclusion of Performance Testing: "demonstrated that the Straumann Variobase C abutments are equivalent to the predicate and reference devices." This implies the device meets the performance characteristics of previously cleared similar devices.

In conclusion, the provided FDA 510(k) summary document pertains to a physical dental implant abutment and does not contain information about an AI/ML medical device or its acceptance criteria and study proving its performance.

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