(92 days)
JiveX is a software only Picture Archiving and Communication System intended to display, process, read, report, communicate, distribute, store, and archive medical data which is available as DICOM or HL7 data, including mammographic images, and bio signals. JiveX also converts case related non-image documents, archives them as DICOM data and serves as a vendor neutral archive.
It supports the physician in diagnosis.
For primary image diagnosis in Mammography only uncompressed images must be used. Also monitors (displays) and printers which received FDA clearance for Mammography must be used. Typical users of this system are trained professionals, including but not limited to physicians, radiologists, nurses, medical technicians, and assistants.
Note: Web-based image distribution and mobile device display of mammographic images are not intended for diagnostic purposes.
For users in the United States of America: Mobile device display is not intended for diagnostic purposes.
JiveX is a software only Picture Archiving and Communication System intended to display, process, read, report, communicate, distribute, store, and archive medical data which is available as DICOM or HL7 data, including mammographic images, and bio signals. JiveX also converts case related non-image documents, archives them as DICOM data and serves as a vendor neutral archive.
It supports the physician in diagnosis.
For primary image diagnosis in Mammography only uncompressed or non-lossy compressed images must be used. Also monitors (displays) and printers which received FDA clearance for Mammography must be used. Typical users of this system are trained professionals, including but not limited to physicians, radiologists, nurses, medical technicians, and assistants.
Note: Web-based image distribution and mobile device display of mammographic images are not intended for diagnostic purposes.
For users in the United States of America: Mobile device display is not intended for diagnostic purposes.
A Communication Server is communicating, storing, and archiving DICOM data and also renders images for the web based image distribution.
Fat clients, rich in rendering and image manipulation functionality, are medical diagnostic and viewing workplaces. When using FDA cleared monitors diagnosis on digital mammography images is possible.
The web based clients are intended for image distribution on either personal computers or mobile devices in the first place. As far as the limited functionality of the web clients allows for it, the web clients may also be used on personal computers for reading and reporting.
JiveX in release 5.0 (K162008) is a predecessor of the device. Functionality has been enhanced and ported to current operating systems and hardware. The most notable enhancements are:
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- JiveX Web has been qualified for reading. As far as the limited functionality of JiveX Web allows for it, it may now be used for reading and reporting. Nevertheless the main use case of the web clients remains image distribution.
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- Enhancements of the viewing clients include:
- Optimized display of temporal series of 3D volumes: streamlined navigation to the same location in space at another point in time.
- Curved MPR: multi planar reconstruction of views along a path curved in 3D
- Support of presentation states in the web clients.
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- Enhancements of the Healthcare Content Management (HCM) infrastructure include:
- refinement of the access privileges down to individual documents.
- Handling of patient IDs from different institutions throughout the system using assigning authority IDs and master patient IDs.
- Improvements of pre-fetching designed for use cases where image data is stored in 3rd party PACS.
- The new module JiveX Signature Gateway provides an interface to 3rd party signature servers. It allows to electronically sign documents imported into the HCM system and to validate electronic signatures.
- The new module JiveX WADO Gateway provides a web interface using the standard DICOM WADO-URI protocol. It allows to retrieve images or documents based on instance UID or the document ID.
The provided text is a 510(k) summary for the JiveX Picture Archiving and Communication System (PACS). It describes the device, its intended use, and its technological characteristics. However, it does not contain specific details about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, or other elements related to rigorous performance evaluation studies.
The document states that JiveX is a software-only medical device and its performance relies on the display, processing, reading, reporting, communication, distribution, storage, and archiving of medical data, including mammographic images. It emphasizes the need for uncompressed images and FDA-cleared monitors/printers for primary image diagnosis in Mammography.
The "Summary of Non-Clinical Testing" section describes general verification and validation processes like:
- Review of requirements, software design, and code.
- Review and acceptance of newly implemented functionality.
- Daily builds and automated tests (unit, component, x-component, UI).
- Verification/validation of "off the shelf software".
- Informal test runs of manual test cases and risk functionality.
- Evaluation of selected software functionality with customers.
- Impact testing for all introduced changes.
- Formal test runs of manual test cases for new/modified functionality.
- Additional impact testing after formal test runs.
It also mentions that risk analysis identifies potential hazards, which are controlled by design measures and verification/validation testing. Device labeling includes instructions, cautions, and warnings for safe use.
Therefore, based on the provided text, the specific information requested in the prompt (acceptance criteria, study details, sample sizes, expert qualifications, etc.) for demonstrating device performance against quantitative metrics is not available. The document focuses on regulatory compliance, outlining the device's substantial equivalence to a predicate device (JiveX 5.0, K162008) based on intended use, technological characteristics, and feature set, without detailing a performance study as typically understood for AI/CAD devices.
§ 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).