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Dentiq3D is dental imaging software that is intended to provide diagnostic tools for maxillofacial radiographic imaging. These tools are available to view and interpret a series of DICOM compliant dental radiology images and are meant to be used by trained medical professionals such as radiologist and dentist.

Dentiq3D is intended for use as software to load, view and save DICOM images from CT, panorama, cephalometric and intraoral imaging equipment and to provide 3D visualization, 2D analysis, in various MPR (Multi-Planar Reconstruction) functions.

Dentiq3D is a dental image software platform for the 3D visualization and analysis of volume data. Dentig3D is optimized for analyzing volume data from CT scan and enables users to examine volume data through 3D visualization, 2D analysis, and various MPR functions to manipulate CT images. The functions include canal tracing, implant simulation, volume segmentation and airway measurement.

The following are the major functions of Dentiq3D.

• Visualizes CT volume data
• Supports various types of data
• Measures 3D object
• Analyzes and filters volume data
• Publishes various forms of report
• 3D visualization by using GPU
• Loads and saves project files
• Restores (Undo) or repeats (Redo) tasks based on operation history
• Supports a user-friendly interface

The provided text describes a 510(k) submission for the Dentiq3D dental imaging software. However, it does not contain specific acceptance criteria or a study detailing the device's performance against such criteria.

The document states:
"Verification, validation and testing activities were conducted to establish the performance, functionality and reliability characteristics of the subject device. The device passed all of the tests based on pre-determined Pass/Fail criteria." (Page 5, Section 12. Performance Data)

This indicates that internal testing was performed, but the details of these tests, including acceptance criteria, reported performance, sample sizes, ground truth establishment, or expert involvement, are not provided in this 510(k) summary.

Therefore, I cannot fulfill the request to provide the following information from the given text:

• A table of acceptance criteria and the reported device performance
• Sample sized used for the test set and the data provenance
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts
• Adjudication method for the test set
• If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
• The type of ground truth used
• The sample size for the training set
• How the ground truth for the training set was established

The document focuses on establishing substantial equivalence to predicate devices (Ez3D Plus and InVivo Dental) based on intended use, technical characteristics, and functionalities, rather than presenting detailed performance study results.

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