(41 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 & K173863) 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
The provided text is a 510(k) summary for the EzDent-i / E2 / Prora View dental imaging software. Based on the information given, here's an analysis addressing your questions:
1. A table of acceptance criteria and the reported device performance
The document 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."
- "The subject device and the unmodified device are substantially equivalent, having the same indications for use and functionalities like operation software, computer platform, picture archiving and communication format, image format, image processing features, windowing. image edit, measurements and manipulation."
- "The differences are that the subject device has changes in PC System Requirement Information Change, Settings upgrade (Annotation, Privacy Policy, adding Help Document, VIEWER tab upgrade (Export Image with Overlay, Saving as IO Sensor Image) and adding SERVICE tab. These differences are not significant since they are additional features for user convenience and do not raise the questions of safety or effectiveness."
Crucially, this 510(k) summary does not provide a specific table of quantitative acceptance criteria or detailed performance metrics. The core of this submission is to demonstrate substantial equivalence to a previously cleared device (EzDent-i / E2 / ProraView, K172364). The "performance data" section only states that testing was done and passed pre-determined criteria, but it does not specify what those criteria were (e.g., minimum accuracy, sensitivity, specificity for a diagnostic task). The changes appear to be primarily related to software features, user interface, and system compatibility, rather than fundamental diagnostic algorithm performance.
Therefore, a table of acceptance criteria and reported device performance specific to diagnostic accuracy (e.g., AUC, sensitivity, specificity) cannot be extracted from this document because it's not a de novo submission or a significant change that would necessitate such detailed performance validation for diagnostic claims.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample size used for any test set or the provenance of the data (country of origin, retrospective/prospective). Given that the submission focuses on substantial equivalence based on feature updates rather than new diagnostic claims, it's unlikely a large-scale diagnostic performance study with specific sample sizes was conducted. The testing likely focused on functional verification and validation of the new software features.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the document. Since the submission is not focused on validating a new diagnostic algorithm's performance against ground truth, there's no mention of expert-established ground truth or expert qualifications used for such a test.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document.
5. 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
No such study (MRMC or otherwise demonstrating human reader improvement with AI assistance) is mentioned or implied in this 510(k) summary. The device's purpose is "to provide diagnostic tools" and is "meant to be used by trained medical professionals such as radiologist and dentist" for viewing and interpreting images. It is not described as an AI-powered diagnostic aid that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This document does not indicate that a standalone algorithm performance study was conducted. The device is described as software that provides tools for human interpretation, not an autonomous diagnostic algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Since the document does not detail a diagnostic performance study, the type of ground truth used is not specified.
8. The sample size for the training set
This information is not provided. The device is described as "dental imaging software," and it's unclear if it even employs machine learning/AI models that would require a "training set" in the conventional sense for diagnostic tasks. The changes described are primarily software features and compatibility updates.
9. How the ground truth for the training set was established
Not applicable, as no information about a training set or its ground truth establishment is provided.
Summary of what's provided for acceptance criteria and proof of meeting them:
The 510(k) submission for EzDent-i / E2 / Prora View (K190087) focuses on demonstrating substantial equivalence to its predicate device (K172364) following software updates. The acceptance criteria described are primarily functional:
- The device retains the same indications for use.
- The device maintains the same functionalities as the predicate, including image acquisition, viewing, saving, loading DICOM files, image processing features (brightness, contrast, measurement), and simulation tools.
- New features (PC system requirement changes, settings upgrades, viewer tab upgrades, service tab) are deemed "additional features for user convenience" and do not raise new questions of safety or effectiveness.
- "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."
The proof of meeting those criteria is presented as the statement that "the device passed all of the tests based on pre-determined Pass/Fail criteria" and the FDA's ultimate determination of substantial equivalence. The document does not disclose the specific quantitative criteria or the detailed results of those tests (e.g., specific error rates, precision, or recall for any diagnostic task). This is typical for a 510(k) submission based on substantial equivalence for software updates, where the primary concern is that the changes do not adversely affect existing validated functionality and safety.
§ 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).