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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.

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