(126 days)
MedDream is a software only Medical Image Management and Processing System intended to display, process, read, report, communicate, distribute, store, and archive medical data which is available as DI COM or HL 7 data, including mammographic images, and bio signals. MedDream also converts case related non-image documents, archives them as DICOM data and serves as a vendor neutral archive. It supports the physician in diagnosis. For primary image diagnosis in Mammography only uncompressed images must be used. Typical users of this system are trained professionals, including but not limited to physicians, radioal technicians, and assistants. Note: Web-based image distribution and mobile device display of mammographic images are not intended for diagnostic purposes. For users in the United States of America: Mobile device display is not intended for diagnostic purposes.
MedDream is a software only Medical Image Management and Processing System intended to display, process, read, report, communicate, distribute, store, and archive medical data which is available as DI COM or HL 7 data, including mammographic images, and bio signals. MedDream also converts case related non-image documents, archives them as DICOM data and serves as a vendor neutral archive.
I am unable to provide the detailed information requested regarding the acceptance criteria and study that proves the device meets them. The provided text is an FDA 510(k) clearance letter for the MedDream device and an "Indications for Use" statement.
This document does not contain the detailed study design, acceptance criteria, or performance data for the device. FDA 510(k) clearance letters primarily state that the device has been found substantially equivalent to a predicate device and outline the regulatory requirements for marketing. They do not typically include the technical specifics of the validation studies.
To answer your request, I would need access to the actual 510(k) summary or the full submission, which would detail the performance testing and acceptance criteria. This information is usually found in the device's 510(k) Premarket Notification submission, which may or may not be publicly available in full. The provided text is just the FDA's decision letter.
§ 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).