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The Straumann® Variobase® for Crown AS is a titanium base placed onto Straumann dental implants to provide support for customized prosthetic restorations. Straumann® Variobase® for Crown AS 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. All digitally designed copings and/or crowns for use with the Straumann Variobase® for Crown AS are intended to be sent to Straumann for manufacture at a validated milling center.

The Straumann® Variobase® for Crown AS are pre-manufactured (stock) lower parts of two-piece abutments, sometimes referred to as "bonding bases" or "TiBases". The Straumann® Variobase® for Crown AS are available to fit to Straumann® dental implant platforms NNC (Narrow Neck CrossFit®), RN (Regular Neck), WN (Wide Neck), NC (Narrow CrossFit®), and RC (Regular CrossFit®).

There are two prosthetic heights to allow for treatment flexibility and for each of the bone level connections (NC, RC), there are gingiva heights of 1.00 mm, 2.00 mm and 3.00 mm. The Straumann® Variobase® for Crown AS provides the dental technician and patient with the possibility to have an "Angled Screw channel" in the crown.

The lower side of the Straumann® Variobase® for Crown AS and a small angulation of the innerwall allows the screw-channel exit to move from a position directly above the implant screw channel to a laterally displaced position. Thus the screw-channel exit can be moved a small distance from occlusal contact or esthetic regions where its potential impact to esthetics is smaller, in Figure 1 the screw-channel exit has been moved from the occlusal contact point of an incisor to behind the incisal edge. The patient-specific upper part of the two-piece abutment (referred to as coping or crown) is to be designed via a traditional workflow of casting/pressing or a digital workflow using the dental CAD software Straumann CARES Visual.

There are three components to the Straumann® Variobase® for Crown AS:

• . Straumann® Variobase® for Crown AS (Ti-base)
• o Prosthetic restoration (coping and/or crown)
• o Basal Screw

Here's an analysis of the provided text regarding the Straumann® Variobase® for Crown AS, focusing on acceptance criteria and the study proving it meets those criteria.

1. Table of Acceptance Criteria and Reported Device Performance

The provided FDA 510(k) summary does not explicitly state numerical acceptance criteria in the typical sense (e.g., "device must perform at X% accuracy"). Instead, it focuses on demonstrating substantial equivalence to predicate devices through various performance tests and material comparisons. The "acceptance criteria" can be inferred as successful completion of the listed tests and demonstrating comparable performance or safety profiles to the predicates.

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

The document does not provide details on the specific sample sizes for the test sets (e.g., number of units tested for fatigue, number of software test cases). It broadly states that "bench studies" were conducted.

• Sample Size: Not explicitly stated for performance tests.
• Data Provenance: The studies were internal "bench studies" conducted by Institut Straumann AG. The country of origin of the data is not specified, but the applicant is Institut Straumann AG (Switzerland), with a US contact address. The studies appear to be prospective as they were conducted to support the 510(k) submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable in this context. The device is a physical dental implant component, not an AI/software device requiring expert interpretation for "ground truth" establishment of medical images or patient data. The "ground truth" for performance is based on established engineering standards (ISO, FDA guidance) and validated testing methods.

4. Adjudication Method for the Test Set

This is not applicable. As a physical device undergoing performance and material testing, there is no need for an adjudication method as would be relevant for clinical studies or AI diagnostic tools involving human interpretation.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, an MRMC comparative effectiveness study was not conducted and is not applicable for this type of device. An MRMC study is typically used for diagnostic devices (e.g., AI in radiology) where the performance of human readers with and without AI assistance is being evaluated. This device is a dental implant abutment, not a diagnostic tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone algorithm performance study was not conducted and is not applicable. This is a physical medical device, not a standalone algorithm. Its function is to be physically implanted and support dental restorations. While it supports digitally designed copings, the device itself is not a software algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is based on established engineering standards, material science properties, and validated test methods. Specifically:

• Dynamic fatigue testing: Conformance to ISO 14801 and FDA guidance. This standard dictates how fatigue life is measured and evaluated.
• Software validation: Conformance to IEC 62304 for medical device software lifecycle processes.
• Sterilization validation: Conformance to ISO 17665-1 and ISO/TS 17665-2.
• Biocompatibility: Likely conformance to ISO 10993 series.
• Material specifications: Ti-6Al-7Nb alloy properties.

These standards and specifications define the "truth" against which the device's physical and functional performance is measured.

8. The Sample Size for the Training Set

This is not applicable. The device is a physical medical component. It does not employ machine learning or AI that requires a "training set" of data in the conventional sense. The "training" for this device involves its design, engineering, and manufacturing process based on established dental implant principles.

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

This is not applicable for the same reasons as #8. There is no training set or ground truth in the context of machine learning for this device. The design and validation are based on engineering principles and regulatory standards.

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