(18 days)
EzDent-i 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.
EzDent-i 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.
EzDent-i is a device that provides various features to acquire, transfer, edit, display, store, and perform digital processing of medical images. EzDent-i 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.
EzDent-i 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 & K163533) but the EzDent-i itself does not view, transfer or process 3D radiographs.
EzDent-i 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 images by interfacing with X-ray capture software.
EzDent-i makes it easier to diagnose and analyze 2D dental images with simple and convenient user interface. EzDent-i's main functions are;
- · Easy and convenient data search function for patient information and clinical images
- · Various image viewing format for 2D dental images
- · Various image processing functions including adjustment of brightness and contrast for images
- · Measurement function of length and angle for 2D images
- · Dental implant simulation for treatment planning and effective patient consultation
- · Crown simulation for more effective patient consultation
- · Print function supporting various viewing output format
Based on the provided text, the device in question is the EzDent-i / E2 / ProraView dental imaging software.
Here's the information regarding its acceptance criteria and the study that proves it:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state specific quantitative acceptance criteria (e.g., specific accuracy, sensitivity, or specificity thresholds) for the EzDent-i software. Instead, it refers to general performance and safety verification.
| Acceptance Criteria Category | Acceptance Criteria (as implied) | Reported Device Performance |
|---|---|---|
| Functionality | Device functions as intended for acquiring, viewing, saving 2D images, loading DICOM files, editing, displaying, storing, and performing digital processing of medical images. | "The device passed all of the tests based on pre-determined Pass/Fail criteria." |
| Technical Characteristics | Maintain technical characteristics similar to the predicate device, including operation software, computer platform, picture archiving and communication format, image format, image processing features, windowing, image edit, measurements, and manipulation. | "EzDent-i v2.2 described in this 510(k) has the same intended use and the same technical characteristics as the unmodified device." "The new device and predicate device are substantially equivalent in the areas of technical characteristics, general function, application, and intended use." |
| Safety and Effectiveness | Modifications do not raise questions of safety or effectiveness. Not introduce a fundamentally new scientific technology. | "These differences [additional features] are not significant since they are additional features for user convenience and do not raise the questions of safety or effectiveness." "The new device does not introduce a fundamentally new scientific technology, and the modifications are validated through system level test." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a sample size for a test set in terms of patient cases or images. It mentions "verification, validation and testing activities" but does not detail the nature or size of these tests.
The data provenance (country of origin, retrospective/prospective) is not provided in the text.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not provide any information about the number of experts used to establish ground truth or their qualifications.
4. Adjudication Method for the Test Set
The document does not specify any adjudication method for a test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The document does not mention a Multi-Reader Multi-Case (MRMC) comparative effectiveness study, nor does it discuss the effect size of AI assistance on human readers.
6. Standalone Performance Study
The document describes a standalone performance assessment of the software's functionality and technical characteristics. It states: "Verification, validation and testing activities were conducted to establish the performance, functionality and reliability characteristics of the modified devices. The device passed all of the tests based on pre-determined Pass/Fail criteria." This indicates that the algorithm/software itself was tested for its intended functions. However, it does not provide quantitative results in terms of diagnostic metrics.
7. Type of Ground Truth Used
The document does not explicitly state the type of ground truth used for any testing. Given it's a dental imaging software for viewing and interpreting DICOM images, the "ground truth" for its functionality testing would likely involve verification against expected image displays, processing outcomes, and measurement accuracy, but no specific method like "expert consensus" or "pathology" is detailed for a diagnostic evaluation.
8. Sample Size for the Training Set
The document does not provide any information about the sample size used for a training set. This is consistent with the device being primarily an image management and viewing software rather than one performing automated diagnostic interpretations with AI/ML that typically require large training datasets.
9. How Ground Truth for the Training Set Was Established
Since no training set is mentioned in the context of AI/ML, the document does not describe how ground truth for a training set was established.
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).