(64 days)
eRAD PACS is a PACS and teleradiology system used to receive DICOM images, scheduling information and textual reports, organize and store them in an internal format, and to make that information available across a network via web and customized user interfaces. eRAD PACS is for hospitals, imaging centers, radiologist reading practices and any user who requires and is granted access to patient image, demographic and report information.
eRAD PACS is a PACS system, comprised of acquisition components (GatewayServer and SendServer), a central system manager component (SmartServer), a diagnostic workstation component (Workstation and Viewer), (and an archiving component (ArchiveServer). The data flow is such that patient and on and is optionally delivered to the central system manager, followed by the acquisition of the image objects directly from the image sources or by one of the acquisition components. After receiving the procedure information or after receiving image objects, the central system manager information of and retrieves relevant procedure data from the archive component. When the central system manager registers the acquired image objects and the retrieved prior procedure data, a user can access the information by selecting the item from the operator worklist. The image data is transmitted to by oreading and the user's workstation using the diagnostic workstation components. After using the workstation to view the images, the user optionally dictates a report into the system, after which, a user can play back the dictation and transcribe it to text. Once eRAD PACS's central system manager registers a and the report is available for access by the referring physician, or it can be exported into an information system. At some configured point in time, the image data and the report information is delivered to the archiving component for backup and long-term storage.
eRAD PACS is a PACS and teleradiology system used to receive DICOM images, scheduling information and textual reports, organize and store them in internal format, and to make that information available across a network via web and customized user interfaces.
This document describes the eRAD PACS (Picture Archiving and Communications System), a medical device intended for managing and displaying medical images and related information. However, the provided text does not contain information about specific acceptance criteria for device performance, nor does it describe any study (clinical or otherwise) that proves the device meets such criteria.
The document focuses on:
- Company Identification and Submission Details: Basic administrative information.
- Device Name and Substantial Equivalence: Classifies the device as a PACS soft-copy reading and acquisition system and asserts its substantial equivalence to other legally marketed PACS devices (Stentor's iSite, Toshiba's TICS, Ultravisual's Vortex, Dynamic Imaging's INTEGRADWeb MPR/MIP).
- Device Description and Intended Use: Explains the components and workflow of eRAD PACS (acquisition, central system manager, diagnostic workstation, archiving) and its purpose in hospitals, imaging centers, and radiology practices.
- Software Development: States that the software is designed, developed, tested, and validated according to written procedures.
- Safety and Effectiveness: Claims that the device has a "minor" level of concern and raises no new safety or effectiveness issues compared to predicate devices.
- FDA Communication: A letter from the FDA confirming the device's substantial equivalence and permitting its marketing.
Therefore, based solely on the provided text, I cannot provide the requested information regarding acceptance criteria or the study proving their fulfillment. The document does not describe:
- A table of acceptance criteria and reported device performance: No specific performance metrics (e.g., image quality, processing speed, diagnostic accuracy) or their targets are mentioned.
- Sample size for the test set and data provenance: No test sets, patients, or images used for evaluation are described.
- Number of experts and their qualifications for ground truth: No expert involvement in establishing ground truth is mentioned.
- Adjudication method for the test set: No adjudication process is described.
- MRMC comparative effectiveness study: No study involving human readers with or without AI assistance is mentioned.
- Standalone performance study: No study evaluating the algorithm's performance independent of human readers is described.
- Type of ground truth used: No mention of expert consensus, pathology, or outcomes data being used as ground truth.
- Sample size for the training set: No training set or its size is mentioned.
- How ground truth for the training set was established: Not applicable, as no training set is mentioned.
The document discusses "testing" and "validation" as part of software development, but it does not detail the nature of these tests, their specific objectives, the data used, or the performance metrics achieved. It primarily focuses on the device's functional equivalence to existing PACS systems and adherence to general safety and software development practices.
§ 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).