(28 days)
The OnDemand3D™ is intended for use as a software package which loads DICOM images from CT, MR, X-Ray, stores those and provides 3D visualization and 2D analysis, various MPR (Multi-Planar Reconstruction) functions for further rapid and precise diagnosis.
OnDemand3D™ is a personal computer based dental imaging software which loads DICOM images taken from CT, MR and provides 3D visualization and 2D analysis, various MPR (Multi-Planar Reconstruction) functions for further rapid and precise diagnosis. OnDemand3D™ is designed to provide users easy and familiar user-interface. Also OnDemand3D™ makes it possible to manage medical images more easily and provides advanced tools for 2D and 3D analysis with various rendering functions.
The provided 510(k) summary for CyberMed, Inc.'s OnDemand3D™ device
does not contain information about acceptance criteria or a study that proves the device meets specific performance metrics.
The document is a submission to the FDA for 510(k) clearance, which primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed performance study data against predefined acceptance criteria.
Therefore, I cannot populate the requested table or answer the specific questions about standalone performance, MRMC studies, sample sizes, expert qualifications, or ground truth establishment.
The document states:
- Purpose: "This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92."
- Conclusion: "CyberMed, Inc. concludes that OnDemand3D™ is safe and effective and substantially equivalent to predicate devices as described herein."
This indicates that the submission is based on substantial equivalence, which typically does not involve the detailed performance studies with acceptance criteria that would be found for novel devices or those undergoing PMA. If such performance studies were conducted, they are not detailed in this 510(k) summary.
§ 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).