(59 days)
Prima is a software application that is intended for use in receiving, processing, manipulating, displaying, printing, and archiving mammography images as well as other medical images and data (e.g. US and MR). Images and data can be stored, communicated, and displayed within the system or across computer systems. Prima provides various image processing and measurement tools to facilitate the interpretation of mammography x-ray, breast tomosynthesis, and other multimodality DICOM medical images and enable diagnosis. Lossy compressed mammographic images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA cleared monitor that meets technical specifications reviewed and accepted by the FDA.
Prima is typically used by trained professionals, including radiologists, oncologists, surgeons, technologists and clinicians and may provide information to be used for screening and diagnostic procedures.
Prima is a software application that is intended for use in receiving, processing, manipulating, displaying, printing, and archiving mammography images as well as other medical images and data (e.g. US and MR). Images and data can be stored, communicated, and displayed within the system or across computer systems. Prima provides various image processing and measurement tools to facilitate the interpretation of mammography x-ray, breast tomosynthesis, and other multimodality DICOM medical images and enable diagnosis. Lossy compressed mammographic images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA cleared monitor that meets technical specifications reviewed and accepted by the FDA.
Prima is typically used by trained professionals, including radiologists, oncologists, surgeons, technologists and clinicians and may provide information to be used for screening and diagnostic procedures.
The provided text is a 510(k) summary for a Picture Archiving and Communication System (PACS) software called "Prima." It declares substantial equivalence to predicate devices but does not contain information about specific acceptance criteria, performance studies, or clinical trial data as requested. The summary mentions that the performance of the software was tested in accordance with Hologic's design control procedures to demonstrate intended performance and that testing was successfully conducted, and demonstrates that Prima meets all of its functional requirements and specifications. However, it does not provide details about these tests.
Therefore, I cannot fulfill your request for the specific acceptance criteria and study details. The document focuses on regulatory equivalence rather than detailed performance metrics.
§ 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).