(102 days)
Ez3D Plus 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 Plus 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 plus is a dental imaging software for PCs that provides fast diagnosis through 3D visualization, 2D analysis, and various MPR functions to manipulate CT images in DICOM format.
The features include canal tracing, implant simulation, and bone density profiling of the area surrounding the implant.
Ez3D plus makes 3D image analysis easier through a simple and convenient user interface. The following are the major functions of Ez3D plus.
· Convenient 2D and 3D image observation with the ability to access all the functions of Ez3D plus with a single click of the mouse.
· Quicker image analysis using Cross-Sectional View, which processes vertical images of the dental arch.
▪ Implant simulation tools provide treatment planning and make for effective patient consultations.
· Convenient confirmation of bone density profiles for the areas around an implant site. Combined with canal tracing, a user can also easily locate the implant site in relation to its distance with the mandibular canal.
· Easy access to various rendering methods, including VR (Volume Rendering), MIP, miniIP, and X-rav.
· 3-D image diagnosis through the use of rendering functions like MPR Rotating Axes, Curve, and 3D zoom.
· Segmentation allows users to easily remove unnecessary parts of an image or extract areas that meet a specific data value.
· A range of utilities including Reports, Counsel, and Free Draw.
- · Ability to easily control user settings such as for default windowing and sectional gap/thickness.
- · Convenient management and addition of objects, color maps, and fine tuning presets.
The provided text describes a 510(k) premarket notification for a medical device called "Ez3D Plus." However, it does not contain the detailed information necessary to answer all parts of your request regarding acceptance criteria and the comprehensive study details. The document is primarily a regulatory submission for substantial equivalence.
Here's what can be extracted and what is missing:
1. A table of acceptance criteria and the reported device performance
The document broadly states: "Verification, validation and testing activities were conducted to establish the performance, functionality and reliability characteristics of the subject device. The device passed all of the tests based on pre-determined Pass/Fail criteria."
However, it does not provide a specific table of acceptance criteria or quantified performance metrics (e.g., accuracy, sensitivity, specificity, or specific measurable outcomes for functionalities like implant simulation or bone density profiling).
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This information is not provided in the document.
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. The text mentions that the tools are "meant to be used by trained medical professionals such as radiologist and dentist," suggesting expert involvement in the intended use, but not for ground truth establishment in 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
The document does not mention a MRMC comparative effectiveness study, nor does it discuss AI assistance or human reader improvement effect sizes. The device is described as "dental imaging software" with diagnostic tools, but not explicitly an AI-assisted diagnostic tool that would typically warrant such a study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document 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 the device is not intended for standalone performance without human interpretation, but rather as an adjunctive tool. It doesn't detail a standalone performance study.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not provided in the document.
8. The sample size for the training set
This information is not provided in the document. Given the description, it's unclear if a machine learning model requiring a distinct "training set" in the modern sense was even used. The device seems to be more of an image processing and visualization software.
9. How the ground truth for the training set was established
This information is not provided in the document, as the existence of a distinct training set (and its associated ground truth) is not confirmed.
Summary of available information:
The document serves as a regulatory submission demonstrating substantial equivalence to predicate devices. It states that "Verification, validation and testing activities were conducted... The device passed all of the tests based on pre-determined Pass/Fail criteria." However, it does not provide specific details about these tests, the acceptance criteria, quantified performance results, study designs, sample sizes, expert involvement, or ground truth methodologies typically found in detailed performance studies. The device is presented as an adjunctive tool, meaning human interpretation is always in the loop.
§ 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).