(7 days)
Ez3D-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.
Ez3D-i 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.
Ez3D-i is 3D viewing software for dental CT images in DICOM format with a host of useful functions including MPR, 2-dimensional analysis and 3-dimensional image reformation. It provides advanced simulation functions such as Implant Simulation. Drawing Canal, and Implant Environ Bone Density, etc..for the benefit of effective doctor and patient communication and precise treatment planning.
Ez3D-i is a useful tool for diagnosis and analysis by processing a 3D image with simple and convenient user interface. Ez3D-i's main functions are;
- Image adaptation through various rendering methods such as Teeth/Bone/Soft tissue/MIP
- Versatile 3D image viewing via MPR Rotating, Curve mode
- "Sculpt" for deleting unnecessary parts to view only the region of interest.
- Implant Simulation for efficient treatment planning and effective patient consultation
- Canal Draw to trace alveolar canal and its geometrical orientation relative to teeth.
- "Bone Density" test to measure bone density around the site of an implant(s)
- Various utilities such as Measurement. Annotation. Gallery, and Report
- 3D Volume function to transform the image into 3D Panorama and the Tab has been optimized for Implant Simulation.
- Provides the Axial View of TMJ, the Condyle / Fossa images in 3D and the Section images, and supports functions to separate the Condyle / Fossa and display the bone density.
Here's an analysis of the provided text regarding the acceptance criteria and study for Ez3D-i / E3, specifically focusing on the aspects requested:
Device: Ez3D-i / E3 (Dental imaging software)
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary does not explicitly list specific quantitative acceptance criteria or detailed reported device performance metrics in a table format. Instead, it makes a general statement about the testing performed.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly defined as quantitative metrics. Implied criteria relate to functionality, reliability, and safety. | "The device passed all of the tests based on pre-determined Pass/Fail criteria." |
| Substantial equivalence to predicate device in technical characteristics, general function, application, and intended use. | The 510(k) concludes that the subject device is substantially equivalent to the predicate device Ez3D-i/E3 (K161246) based on having the same intended use and technical characteristics. |
| Differences in new features (USB Model, Quick Settings, Skin Theme, Implant Guide, Dual monitor, 3D Object Manager functions) do not raise new safety or effectiveness concerns. | The document states these differences are "not significant since they do not raise any new or potential safety risks to the user or patient and questions of safety or effectiveness." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for the test set. It also does not mention 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
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 mention any adjudication method used for the test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
The document does not indicate that an MRMC comparative effectiveness study was performed. There is no mention of human readers, AI assistance, or effect sizes related to human performance improvement.
6. If Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
The document describes Ez3D-i as "dental imaging software that is intended to provide diagnostic tools...These tools are available to view and interpret... and are meant to be used by trained medical professionals such as radiologist and dentist." It also states "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."
This strongly suggests that the device is intended for human-in-the-loop use, where the software provides tools, and the medical professional performs the interpretation and diagnosis. The document does not explicitly describe a standalone (algorithm only) performance evaluation.
7. The Type of Ground Truth Used
The document does not explicitly state the type of ground truth used. Given the nature of the device as a viewing and analysis tool for imaging, it is highly likely that the "ground truth" for its verification and validation would involve:
- Known image datasets: Using existing DICOM image sets where the anatomical structures, pathologies, or features are already well-established (e.g., through prior consensus reads, surgical confirmation, or other clinical information).
- Software functionality validation: Testing that the software accurately performs its stated functions (e.g., MPR, 3D visualization, measurements, implant simulation) according to expected outputs, rather than a clinical ground truth for disease detection.
8. The Sample Size for the Training Set
The document does not provide any information about a training set or its sample size. This is consistent with the device being primarily a viewing and analysis tool rather than a machine learning-based diagnostic algorithm that requires explicit training data.
9. How the Ground Truth for the Training Set Was Established
Since no training set is mentioned, there is no information on how its ground truth might have been 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).