(30 days)
RADSpa™ components are intended to be used in hospitals, imaging centers, radiologist reading practices and by any user who requires and is granted access to view patient's images, demographic and report information.
RADSpa™ PACS is a flexible, standards-compliant, web-based, workflow management solution designed for centralized and distributed imaging environments. This device consolidates all radiology exam information including images and reports from multiple systems into a centrally managed work list, which can be accessible using any browser. RADSpa™ PACS provides complete PACS functionality used to receive and manage DICOM images and make the data available across a network. RADSpa™ viewer is used for diagnosis and Primary Image Interpretation of DICOM compliant image data derived from all modalities. This component is not intended for mobile devices.
RADSpa™ MPR/MIP/3D components are used for post-processing and is designed to assist radiologists in the diagnostic analysis, visualization, and quantification of CT and MR images. This device supports enhanced visualization and analysis techniques such as multi-planar and oblique reformats, maximum intensity projections, image averaging, subtraction and blinking of images acquired at different time points.
RADSpa™ MPR/MIP/3D is also used to perform post-processing analysis digital images from CT and MR. The software analysis tools may be applied to image subtractions, reformatted images, multi-planar reformats and maximum intensity projections. The software package includes tools to allow the radiologist to manipulate and fly-through images for enhanced visualization.
RADSpa™ MPR/MIP/3D is not intended for mobile devices.
RADSpa™ is a software device that consists of RADSpa™ PACS and Viewer&RADSpa™ 2D/MPR/MIP/3D viewer.
RADSpa™ PACS components (server-side) enable receiving, storing and sending DICOM images and managing the workflow required for radiologists. The components are developed using .NET and runs on Windows OS. The images are stored in the file system and the workflow-related data in a RDBMS database
RADSpa MPR/MIP/3Dviewer components run on Windows OS and enable downloading of images from RADSpa™ server and viewing and manipulating of those images on the workstation
Overall features include:
- Centralized or Distributed Archive functionality
- Uses commercially available computers, servers, operating systems and network infrastructure, with expandable storage capability
- Single or Multi server options (i.e. Archive, Web Server and PACS application can reside on a single server computer)
- Pre-emptive downloading- perfecting of images in real time Web based solution
- Scalable from single practice to enterprise wide PACS
- High level of security
- DICOM, JPEG and JPEG 2000 compliant
The provided document is a 510(k) summary for the RADSpa™ system, a Picture Archiving Communication System (PACS) with viewing and post-processing capabilities. While it details the device description, intended use, and substantial equivalence to predicate devices, it does not contain information about specific acceptance criteria, performance study results, or validation methodology (e.g., sample size, expert qualifications, ground truth establishment, or multi-reader multi-case studies) for the RADSpa™ device itself.
The document primarily focuses on establishing substantial equivalence to existing PACS systems (ResolutionMDTM 2.1 and eRAD PACS) by comparing features and intended use. The conclusion states that the submission contains "adequate information and data to enable FDA - CDRH to determine substantial equivalence to the predicate device" and mentions a "hazard analysis" and "Level of Concern for potential hazards has been classified as 'minor'". This indicates that the regulatory approval was based on demonstrating equivalence rather than the submission of a new clinical performance study with specific acceptance criteria and results.
Therefore, I cannot extract the requested information from the provided text. The document does not describe:
- A table of acceptance criteria and reported device performance.
- Sample size, data provenance, number of experts, qualifications, or adjudication methods for a test set.
- Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done, or its effect size.
- Standalone (algorithm only) performance.
- The type of ground truth used.
- The sample size for the training set.
- How the ground truth for the training set was established.
§ 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).