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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 or non-lossy compressed images 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 PACS software, with a Moderate level of concern.

A Communication Server is communicating, storing, converting, and archiving images, documents and signal data via DICOM. HL7 and proprietary interfaces. It also renders images for the web-based image distribution.

The fat clients can be used as workstations for medical reading and reporting. They provide extensive functions for image display and image processing. The reporting of digital mammography images is also supported.

The web-based clients are mainly intended for image distribution on personal computers and mobile devices. They offer less functions than the fat clients. As far as the functions allow for it, the web clients can also be used for reading and reporting on personal computers.

The provided text is a 510(k) Premarket Notification summary for the medical device JiveX, release 5.4. This document primarily focuses on demonstrating substantial equivalence to a predicate device (JiveX 5.3) based on identical indications for use and technological characteristics, rather than presenting a performance study for accepting new functionality or claims.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria for new functionality or claims. Specifically:

• No table of acceptance criteria and reported device performance is provided. The document states that "non-clinical performance testing" was done and the "subject device was found to have a safety and effectiveness profile that is similar to the predicate device," but it does not detail specific performance metrics or acceptance thresholds.
• No information is provided about sample size for a test set, data provenance, number of experts for ground truth, or adjudication methods.
• No MRMC comparative effectiveness study is mentioned. The document focuses on demonstrating equivalence to a previous version of the same product.
• No standalone (algorithm-only) performance is discussed.
• The type of ground truth used for any performance evaluation is not specified.
• No sample size for a training set or method for establishing ground truth for a training set is provided. This type of information would typically be relevant for AI/ML-based devices with novel algorithms, which is not the primary focus of this 510(k) submission.

The "Performance Data" section solely describes a typical software verification and validation process (reviews, automated tests, manual test cases, regression testing), which is general software quality assurance, not a specific performance study against defined acceptance criteria for a new clinical claim. The core argument for substantial equivalence relies on the fact that the indications for use and technological characteristics of JiveX 5.4 are identical to its predicate, JiveX 5.3.

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