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iTero software is used with the iTero scanner in capturing 3D digital impressions of teeth, oral soft tissue and structures, and bite relationship. iTero software controls the processing of the data, facilitating the integration of data, and exporting of the data for CAD/CAM fabrication of dental restorations, orthodontic devices, abutments, and accessories. In addition to scan data, various patient and case information can be imported/exported or used for simulation purposes. Other functions are available for verification and service of the system and to serve as an order management tool.

The iTero software is used with the iTero scanner in capturing 3D digital impressions of teeth, oral soft tissue and structures, and bite relationship. The software supports dental professionals in acquiring very accurate digital images which can be edited and used for planning and simulation. The software controls the export of the data by a secured internet connection for CAD/CAM fabrication of dental restorations, orthodontic devices, abutments, and accessories.

This document refers to the iTero Software and details its 510(k) submission.

Here's an analysis of the acceptance criteria and the study data it provides:

1. Table of Acceptance Criteria and Reported Device Performance

The document states: "Results of verification/validation testing demonstrate that iTero Software showed conformity with pre-established specifications and acceptance criteria. The acceptance criteria were established in order to demonstrate that iTero Software is safe and effective for its intended use."

However, the specific "pre-established specifications and acceptance criteria" themselves are not detailed in this provided text. Nor are specific numerical performance metrics from the device's testing reported in a table format. The text only offers a general statement of conformity.

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

This information is not provided in the given text.

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

This information is not provided in the given text.

4. Adjudication Method for the Test Set

This information is not provided in the given text.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not described or referenced in the provided text. The submission focuses on the software's functionality and equivalence rather than an AI-assisted human reader improvement study.

6. Standalone Performance Study

The document indicates that "Results of verification/validation testing demonstrate that iTero Software showed conformity with pre-established specifications and acceptance criteria." This implies a standalone evaluation of the software's performance against its technical and functional specifications. While not explicitly using the term "standalone study," the focus on its own performance against internal criteria suggests a standalone assessment. However, specific metrics of this standalone performance are not provided.

7. Type of Ground Truth Used

The type of ground truth used for verification/validation testing is not explicitly stated. Since the device captures 3D digital impressions, the ground truth would likely involve comparisons to physical models, highly accurate traditional impressions, or possibly other high-precision 3D scanning technologies, but this is an inference based on the device's function, not explicit in the text.

8. Sample Size for the Training Set

This information is not provided in the given text. The iTero Software is described as controlling the processing, integration, and export of scan data, and also for planning and simulation. It's not explicitly presented as an AI/Machine Learning device that undergoes a "training" phase in the conventional sense, as might be the case for image recognition or diagnostic algorithms. Instead, it seems to be a software tool for data acquisition, processing, and management.

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

As the document does not describe a "training set" in the context of an AI/ML algorithm, this information is not applicable/provided. The software's capabilities are more in line with data processing and visualization rather than learning from a dataset to perform a task.

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