(10 days)
eUnity is a software application that displays medical image data and associated clinical reports. eUnity performs operations relating to the transfer, storage, display, and measurement of image data.
eUnity allows users to perform image manipulations, including window/level, rotation, zoom, measurement and markup.
eUnity displays both lossless and lossy compressed images. For lossy images, the medical professional user must determine if the level of loss is acceptable for their purposes.
Display monitors used for reading medical images for diagnostic purposes must comply with applicable regulatory approvals and with quality control requirements for their use and maintenance.
Mammographic images and digitized film screen images must not be reviewed for primary image interpretations.
eUnity is a software application that displays medical image data and associated clinical reports. eUnity performs operations relating to the transfer, storage, display, and measurement of image data.
eUnity allows users to perform image manipulations, including window/level, rotation, zoom, measurement and markup.
eUnity displays both lossless and lossy compressed images.
This looks like a 510(k) clearance letter for the device "eUnity," which is a Picture Archiving and Communications System (PACS). The provided document is primarily an FDA clearance letter and an Indications for Use form. It does not contain the detailed study information, acceptance criteria, or performance data that you are requesting.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based only on the provided text. This information would typically be found in the 510(k) summary or the full premarket notification submission to the FDA, which is not included here.
The document states that the device is "substantially equivalent" to a legally marketed predicate device. This substantial equivalence determination often means that the device's technical characteristics and intended use are similar enough to an existing device that extensive new clinical studies to prove effectiveness and safety might not have been required, or that engineering bench tests and demonstrations of equivalence were sufficient.
To answer your questions, I would need access to the actual 510(k) submission document or a summary from the FDA's database that includes the performance data and study details.
§ 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).