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The Straumann CARES Visual/Nova Implant-borne CAD software are indicated for the design of two-piece or one-piece abutment components for single or multiple-unit implant-borne prosthetics for the restoration of partially or fully edentulous mandibles and maxillae. The system integrates multiple components of the digital dentistry workflow: scan files from Intra-Oral Scanners or Extra-Oral Scanners and CAD software. The system is used to design two-piece abutment CAD/CAM milled copings, crown and bridge restorations to be cemented onto Ti-bases, customized one-piece abutments and bridges/bars to be affixed to the endosseous dental implants using a basal screw. The use of the software requires the user to have the necessary training and domain knowledge in the practice of prosthetic design, as well as training in the use of the software.

Straumann CARES Visual/Nova is a dental CAD software to create implant-borne restorations. The software employs optical impression files that represent the topographical characteristics of the patient's intraoral situation. The Straumann CARES Visual/Nova software then allows the desired restorations. All implant-borne restorations available in Straumann CARES Visual/Nova software require FDA review and 510(k) clearance. Design specifications ("design envelope"), selectable materials, mouth positions need to be described in these 510(k) submissions. Each restorative solution is defined in a secured design library that provides the CAD software with the design specifications and restrictions for instance, minimum wall thickness, maximum angulation, cementable abutment post height etc. Standard connecting geometries e.g., abutment to implant interface are also defined in the library which cannot be edited by a user. Any dental implantborne restoration can only be created within the 510(k)-cleared design envelope.

The output of the CAD software is a three-dimensional geometry file which is linked to meta data like material and patient identifier.

All designed implant-borne restorations are intended to be:

• sent to Straumann for manufacturing by a validated milling center, or .
• milled on a validated Straumann C series or M series milling machine (only . with the CARES Visual software, K171649 and K203456)
• 3D printed as a temporary crown, or temporary bridge (up to 180 days) using P pro . Crown & Bridge material on a validated Straumann P series printer (only with the CARES Visual software, K203750)

Straumann CARES Visual/Nova has no patient contact since it is software.

The provided text is a 510(k) summary for the Straumann CARES Visual and Nova Dental CAD software. This document outlines the device's indications for use, its technological characteristics, and a comparison to predicate devices, but lacks detailed performance study information with numerical acceptance criteria and measured performance.

Here's an analysis of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document mentions "Performance Testing - Bench" and "Software verification and validation testing," indicating that tests were performed to demonstrate that the software adheres to design specifications and restrictions. However, it does not provide specific numerical acceptance criteria (e.g., accuracy percentages, dimensional tolerances) or their corresponding numerical performance results.

Instead, the acceptance criteria are implicitly described as:

• The software effectively controls design specifications and material selections for compatible abutment design libraries that undergo separate 510(k) clearance.
• Restrictions prevent the design of patient-matched components outside of allowable design limitations.
• Design limitations and specifications of compatible implant-abutment design libraries are locked and cannot be modified by the end user.

The reported performance is a general statement that these tests were "provided to demonstrate" and "conducted to demonstrate" these aspects. No quantitative measurements are included.

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

The text does not specify the sample size used for the test set or the provenance of any data (e.g., country of origin, retrospective/prospective). It only refers to "representative screenshots under user verification testing," which suggests qualitative evaluation rather than quantitative statistical analysis on a defined dataset.

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

The document does not mention the use of experts to establish ground truth for a test set. The validation appears to be centered on the software's functionality and adherence to predefined design rules rather than a comparison to expert-derived ground truth on clinical cases.

4. Adjudication Method for the Test Set

As there's no mention of experts establishing ground truth or evaluating cases, there is no adjudication method described.

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

No MRMC comparative effectiveness study is mentioned. The device is CAD software for designing dental prosthetics, which is different from an AI-assisted diagnostic tool where human reader performance would typically be assessed.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

The performance testing described is inherently standalone from a human-in-the-loop perspective, as it verifies the software's ability to enforce design rules and generate valid geometry files. The software's output (geometry file) is then used for manufacturing. The device inherently functions "without human-in-the-loop performance" in terms of its core design rule enforcement, although a human user still operates the software to create the design.

7. The Type of Ground Truth Used

The ground truth for this device appears to be primarily predefined design specifications and limitations based on engineering rules, material properties, and anatomical considerations for dental prosthetics. The software's internal logic and libraries incorporate these rules. It's not based on expert consensus, pathology, or outcomes data in the typical sense of a diagnostic or predictive AI.

8. The Sample Size for the Training Set

The document does not mention a training set for the software. This suggests that the software is likely rule-based CAD software rather than a machine learning or AI model that requires a training set of data. Its functionality is based on programmed algorithms and predefined libraries ("design envelope").

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

Since no training set is mentioned, this point is not applicable.

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