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The EzDent-i /E2 /ProraView/ Smart M Viewer 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.

The EzDent-i F2 /ProraView/ Smart M Viewer is intended for use as software to acquire, view, save 2D image files, and load DICOM project files from panorama, cephalometric, and intra-oral imaging equipment.

The EzDent-i / E2 / Prora View / Smart M Viewer v.3.3 is a device that provides various features to acquire, transfer, edit, display, store, and perform digital processing of medical images. The subject device is a patient & image management software specifically for digital dental radiography. It also provides server/client model so that the users upload and download clinical diagnostic images and patient information from any workstations in the network environment.

It also supports general image formats such as JPG and BMP for 2D image viewing as well as DICOM format. For 3D image management, it provides uploading and downloading support for dental CT Images in DICOM format. It interfaces with a 3D imaging software made by our company, the Ez3D-i (K131616, K150761, K161246, K163539, K173863, K190791, K200178, K211791) but does not view, transfer or process 3D radiographs.

The subject device supports the acquisition of dental images by interfacing with OpenCV library to import the intra-oral camera images. It also supports the acquisition of CT/Panoramic/Cephalo/Intra-Oral Sensor /Intra-Oral Scanner images by interfacing with Xray capture software.

This document describes a 510(k) premarket notification for the EzDent-i / E2 / ProraView/ Smart M Viewer, a dental imaging software. The submission aims to demonstrate substantial equivalence to a previously cleared version of the same software (EzDent-i / E2 / Prora View / Smart M Viewer v.3.2, K211795).

Based on the provided information, the following can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria or detailed device performance metrics in a pass/fail format. Instead, it relies on a statement that "The device passed all of the tests based on pre-determined Pass/Fail criteria." The study's focus was on demonstrating that modifications made to the software "do not raise the questions of safety or effectiveness" and that the newer version is substantially equivalent to the predicate device.

The reported device performance, in terms of meeting criteria, is implicitly described as:

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

The document states that "SW verification/validation and the measurement accuracy test were conducted." However, it does not provide any details regarding:

• The specific sample size (e.g., number of images, number of cases) used for the test set.
• The data provenance (e.g., country of origin, retrospective or prospective nature of the data).

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

This information is not provided in the document. The document mentions that the software's diagnostic tools are "meant to be used by trained medical professionals such as radiologist and dentist" and that "Results produced by the software's diagnostic, treatment planning and simulation tools are dependent on the interpretation of trained and licensed radiologists, clinicians and referring physicians as an adjunctive to standard radiology practices for diagnosis." However, it does not specify how ground truth was established for the performance testing.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method (e.g., 2+1, 3+1, none) used for establishing ground truth for the test set.

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

An MRMC comparative effectiveness study was not performed or reported in this submission. The study focuses on demonstrating substantial equivalence of the modified software version to its predicate through software verification/validation and measurement accuracy testing, rather than evaluating human reader performance with or without AI assistance.

6. Standalone (Algorithm Only) Performance Study

A standalone performance study focused on the algorithm's performance without human-in-the-loop interaction was performed implicitly through the "SW verification/validation and the measurement accuracy test." These tests are typically designed to assess the software's intrinsic functionalities and accuracy parameters independently. The submission indicates that these tests were conducted and passed. However, specific metrics (e.g., sensitivity, specificity, AUC) for diagnostic capabilities are not provided, as the device is characterized as a "medical image management and processing system" with "diagnostic tools," meaning it is an adjunctive tool for image interpretation by clinicians.

7. Type of Ground Truth Used

The type of ground truth used for the "SW verification/validation and the measurement accuracy test" is not explicitly stated. Given the nature of a "medical image management and processing system" and its function of enabling trained professionals to "view and interpret" images and provide "diagnostic tools," the ground truth for measurement accuracy tests would likely involve precisely measured objects or features within reference images. For software functionality, it would involve confirming that features operate as intended based on predefined specifications. Pathology or outcomes data are not mentioned as being used for ground truth.

8. Sample Size for the Training Set

The document does not provide any information about a training set or its sample size. This submission describes an updated version of existing software, and the evaluation focuses on comparing it to a predicate device rather than on the development and training of a new AI algorithm.

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

As no training set is mentioned, information on how its ground truth was established is not applicable/not provided in this document.

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