(15 days)
IntelePACS™ is a device that receives digital images and data from various sources (such as, CT scanners, MR scanners, ultrasound systems, R/F units, computer and direct radiographic devices, secondary capture devices, scanners, imaging gateways, or other imaging sources). lmages and data can be communicated, processed, manipulated, enhanced, stored, and displayed within the system and/or across computer networks at distributed locations. Postprocessing of the images can be performed using Multi Planar Reconstruction (MPP),
Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mannographic images may only be interpreted using an FDA approved monitor that protateliar manimographio may only be medification specifications reviewed and accepted by FDA.
Typical users of this system are trained professionals, physicians, nurses, and technicians.
IntelePACS™ is comprised of software modules that provide image capture, storage, distribution, enhancement, manipulation, and networking of medical images at distributed locations. In cases where DICOM images are not directly available to IntelePACS™, the system can acquire medical imem mugos using a DICOM image gateway, which generates DICOM-type files. For example, and a Broom images from original film and convert them to meet DICOM standards and stored. Stored files are transmitted using a network and can be viewed or manipulated from imaging workstation.
The provided text is a 510(k) summary for IntelePACS™. After a thorough review, it is clear that this document does not contain the acceptance criteria or a study proving that the device meets such criteria.
The 510(k) summary focuses on establishing substantial equivalence to predicate devices, providing a device description, and outlining indications for use. It mentions that the system will be manufactured in accordance with voluntary standards, and a hazard analysis classified potential hazards as "minor," but these are not the detailed performance acceptance criteria and study results typically expected for a medical device.
Therefore, I cannot provide the requested table or answer the specific questions about the study, sample sizes, ground truth, or expert involvement based on the provided text. The document is primarily a regulatory submission demonstrating equivalence, not a scientific study report.
§ 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).