Search Results

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.

Note: Web-based image distribution and mobile device display are 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.

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.

JiveX is a client server solution that is mainly implemented in Java. Clients run on personal computers with MS windows operating systems. The mobile client runs on iPAD. The server also runs on MS Windows operating systems using server hardware either directly or via virtual machines.

JiveX is a software only medical device.

The provided text is a 510(k) Summary for the JiveX Picture Archiving and Communication System (PACS). It compares JiveX 5.0 to a predicate device, JiveX 4.7. However, it does not contain information about specific acceptance criteria, device performance metrics, or a study reporting those metrics to prove the device meets acceptance criteria.

Instead, the document focuses on demonstrating substantial equivalence to a predicate device by comparing intended use, technological characteristics, and a feature set. It describes software development and testing processes but does not present quantitative performance data.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set and data provenance.
3. Number of experts and qualifications for ground truth.
4. Adjudication method for the test set.
5. MRMC comparative effectiveness study or related effect size.
6. Standalone performance study for the algorithm.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

This type of information is typically required for AI/ML-driven medical devices that make diagnostic classifications or predictions, which is not the primary function of a PACS system like JiveX according to this document. JiveX is a system for displaying, processing, storing, and archiving medical data, supporting the physician in diagnosis, rather than performing it autonomously. Its software validation focuses on functionality, reliability, and safety in handling and presenting medical data, not on diagnostic accuracy of an AI model within the PACS.

Ask a specific question about this device

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.

Note: Web-based image distribution and mobile device display are 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.

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.

JiveX is a client server solution that is mainly implemented in Java. Clients run on personal computers with MS windows operating systems. The mobile client runs on iPAD. The server also runs on MS Windows operating systems using server hardware either directly or via virtual machines.

JiveX is a software only medical device.

The provided text does not contain specific acceptance criteria or details of a study designed to prove the device meets said criteria.

The document is a 510(k) premarket notification for a Picture Archiving and Communication System (PACS) named JiveX. It primarily focuses on establishing substantial equivalence to previously cleared predicate devices. While it mentions "Verification and validation is done through all development phases" and lists various testing activities (review of requirements, software design, automated tests, manual test cases, evaluation with customers, impact testing), it does not provide quantitative acceptance criteria or a detailed study report with results for the JiveX system itself.

Therefore, I cannot populate the requested table or answer the specific questions about sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth details.

The document indicates that JiveX is considered substantially equivalent to the following:

• Predicate Device 1: JiveX (K053183) by VISUS Technology Transfer GmbH
• Predicate Device 2: syngo.plaza VB10A (K132532) by SIEMENS AG, Medical Solutions

The rationale for substantial equivalence is based on:

• Equivalent intended use
• Shared technological characteristics
• Similar feature set

The submission states that JiveX "does not raise any new issues of safety and efficacy," implying that the safety and effectiveness are supported by the predicate devices and the general development and testing processes mentioned.

Ask a specific question about this device

To be used with images from a variety of radiological modalities including CT, MRI, ultrasound, nuclear medicine, CR, DR, etc. to store and retrieve images and patient information.

Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.

Not Found

This is a predicate device letter for JiveX Picture Archiving and Communications System (PACS) from 2006. This type of letter determines substantial equivalence to previously cleared devices under 510(k) regulations. It does not present acceptance criteria or a study demonstrating the device meets them because such studies are not typically required for 510(k) clearances of PACS systems.

PACS devices like JiveX are generally considered "general purpose" devices for viewing, storing, and retrieving medical images. Their substantial equivalence is typically based on demonstrating that they perform the same functions as legally marketed predicate devices, with similar technological characteristics, and do not raise new questions of safety or effectiveness. Performance claims beyond these basic functions would usually require specific studies.

Therefore, I cannot provide the requested information from the provided text as it is not contained within a 510(k) clearance letter for a PACS system.

Ask a specific question about this device