(87 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 of in DICOM format with a host of useful functions including MPR, 2D analysis and 3D image reconstruction. It provides more advanced simulation functions such as Implant Simulation, Drawing Canal, and Implant Area Bone Density, etc for the benefit of effective communication between doctor and patient as well as 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;
- Effortless 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. ー
- "Bone Density" test to measure bone density around the site of implants. -
- -Various utilities such as Measurement, Annotation, and Gallery, Report
The provided text does not contain specific acceptance criteria or a detailed study proving the device meets those criteria. The submission states that the device "passed all in-house testing criteria" and that "the validation testing verified and validated the risk analysis and individual performance results were within the predetermined acceptance criteria." However, it does not explicitly list what those acceptance criteria were or the details of the study performed.
Therefore, I cannot populate the requested table and answer the specific questions because the information is not present in the provided 510(k) summary.
Missing Information:
- Specific Acceptance Criteria: The document mentions "predetermined acceptance criteria" but does not define them (e.g., minimum accuracy, sensitivity, specificity, or specific error rates for any function).
- Reported Device Performance: Since acceptance criteria are not defined, the reported performance against those specific criteria is also not provided.
- Details of "Software Validation Test": While a software validation test is mentioned, its specifics (e.g., what was tested, how errors were measured, specific results) are not elaborated.
- Information related to human readers, ground truth establishment, or training sets: The document describes the device's functions and its substantial equivalence to a predicate device but does not detail any studies involving human readers, the establishment of ground truth for training or test sets, or the sizes of such sets.
What is present:
- The device is "Ez3D-i / E3," dental imaging software.
- It performs 3D viewing, MPR, 2D analysis, implant simulation, canal drawing, and bone density measurement for dental CT images.
- It was tested in-house, and "all in-house testing criteria" were passed.
- The software validation test aimed to evaluate input, output, and actions.
- The device is substantially equivalent to the predicate device OnDemand3D (K113543).
- It complies with IEC 62304 and ISO 14971.
Without the specific details of the acceptance criteria and performance study, I cannot complete the requested information.
§ 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).