(78 days)
RadiForce GS510 is intended to be used in various kinds of medical image applications including digital mammography system for which the device complies with the performance specified by the manufacturer of the system.
RadiForce GS510 device is a digital image display. G51 displays high-definition (5 Megapixel) medical imaging.
I am sorry, but the provided text only contains a 510(k) summary and FDA clearance letter for a medical display monitor (RadiForce GS510). It does not contain any information about a study that assesses the performance of a device against acceptance criteria, nor does it describe acceptance criteria for such a study.
The document discusses the device's technical specifications and its substantial equivalence to a predicate device, focusing on its use in medical imaging applications. It does not mention any clinical trials, performance studies with human readers, or the establishment of ground truth by experts. Therefore, I cannot extract 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).