(65 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 prompt and accurate diagnosis dental CT images in DICOM format with a host of useful functions including MPR, 2-dimensional analysis and 3dimensional 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 an easier 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
- STO/VTO Simulation to predict orthodontic treatment/ surgery results with 3D Photo image.
- · Segmentation function to get tooth segmentation data from CT, label each segmented tooth data as an object and utilize them in simulation such as tooth extraction, implant simulation, etc.
The provided text is a 510(k) summary for the Ez3D-i / E3 dental imaging software. While it states that performance data exists and the device passed tests based on pre-determined criteria, it does not provide any specific quantitative acceptance criteria or the detailed results of a study to demonstrate that the device meets those criteria.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance.
- Effect size of MRMC study (as no such study is described).
- Description of a standalone performance study.
However, I can extract the following information:
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified.
- Data Provenance: Not specified. The document only mentions that the software loads, views, and saves DICOM images from various dental imaging equipment.
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)
- Not specified. The document only states that the device is "meant to be used by trained medical professionals such as radiologist and dentist."
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not specified.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not specified. The document mentions that the software provides "diagnostic tools" and "advanced simulation functions" 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." This implies reliance on expert interpretation, but the specific type of ground truth used for testing is not detailed.
8. The sample size for the training set
- Not specified.
9. How the ground truth for the training set was established
- Not specified.
Additional Information from the Document:
- Device Type: Dental Imaging Software (Ez3D-i / E3)
- Intended Use: "to provide diagnostic tools for maxillofacial radiographic imaging... 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." Also intended "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."
- Predicate Device: Ez3D-i / E3 (K163539) by EWOO SOFT Co., Ltd.
- Safety and Effectiveness Claim: The submission claims substantial equivalence to the predicate device because "The new device and the predicate device are substantially equivalent in the areas of technical characteristics, general function, application, and intended use. The new device does not introduce a fundamentally new scientific technology, and the nonclinical tests demonstrate that the device is safe and effective."
- New Features in Subject Device: "additional features such as tooth segmentation function and orthodontic simulation function using 3D Photo and segmented data from CT including bone model and tooth model data. Its file import menu and MPR tab also have been upgraded."
- Justification for Equivalence despite new features: "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."
- Performance Data Statement: "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." (However, the criteria and results are not listed).
§ 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).