(27 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.
JiveX is a PACS software, with a Moderate level of concern.
A Communication Server is communicating, storing, and archiving images, documents and signal data via DICOM, HL7 and proprietary interfaces. It also renders images for the webbased image distribution.
The fat clients can be used as workstations for medical reading and reporting. They provide extensive functionality 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 functionality than the fat clients. As far as the functionality allows for it, the web clients can also be used for reading and reporting on personal computers.
JiveX in release 5.0.6 (K181964) is a predecessor of the device. Functionality has been enhanced and ported to current operating systems and hardware.
The provided text is a 510(k) Summary for the JiveX Picture Archiving and Communication System (PACS). This document does not contain a study that proves the device meets specific acceptance criteria for a diagnostic aid. Instead, it focuses on demonstrating substantial equivalence to a predicate device (JiveX 5.0.6) through a comparison of technological characteristics and intended use.
Therefore, many of the requested items (e.g., specific acceptance criteria, reported performance, sample sizes for test/training sets, expert qualifications, ground truth, MRMC studies, standalone performance) are not present in this type of regulatory submission.
However, I can extract information related to the device and its comparison to the predicate.
Here's what can be extracted from the document:
1. A table of acceptance criteria and the reported device performance:
This document does not provide a table of acceptance criteria or reported device performance in the context of a diagnostic accuracy study. The acceptance criteria for this submission are based on demonstrating "substantial equivalence" to a predicate device by showing similar intended use and technological characteristics, and that it raises no new issues of safety or effectiveness.
2. Sample size used for the test set and the data provenance:
- Not Applicable: This document is a 510(k) summary demonstrating substantial equivalence for a PACS, not a diagnostic aid requiring a clinical performance study with a test set of medical cases. There is no mention of a test set with medical data for diagnostic performance evaluation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable: As there is no test set for diagnostic performance, there is no mention of experts establishing ground truth for such a set.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable: No test set for diagnostic performance is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No: The document does not describe an MRMC study. The JiveX PACS is a software system for archiving, displaying, and processing medical data, not an AI-powered diagnostic aid that assists human readers directly to improve diagnostic accuracy.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No: The JiveX PACS is not an algorithm for standalone diagnostic performance evaluation. Its purpose is to manage and display medical data for human interpretation.
7. The type of ground truth used:
- Not Applicable: No ground truth for diagnostic performance is mentioned as this is not a diagnostic performance study.
8. The sample size for the training set:
- Not Applicable: The JiveX PACS is a software system, not a machine learning algorithm that requires a training set of medical data for model development.
9. How the ground truth for the training set was established:
- Not Applicable: As above, no training set is relevant to this submission.
Summary of Non-Clinical Testing (from the document):
The document mentions "Summary of Non-Clinical Testing" which details the verification and validation process for the software, demonstrating its safety and functionality as a PACS, rather than its diagnostic accuracy:
- Review of requirements, software design, code.
- Review and acceptance of newly implemented functionality.
- Daily build of the product and performance of automated tests (unit, component, x-component, UI level).
- Verification/validation of "off the shelf software."
- Informal test runs of new manual test cases and functionality on risk.
- Evaluation of selected software functionality with customers.
- Formal test run of all manual test cases pertaining to new or modified functionality.
- Impact testing for all changes introduced.
- Extensive regression testing.
Conclusion of the Study (from the document):
The "study" presented in this 510(k) summary is a comparative analysis for substantial equivalence against a predicate device (JiveX 5.0.6, K181964). The conclusion is that JiveX 5.2 is substantially equivalent to the predicate device because:
- It has identical intended use.
- It shares technological characteristics.
- It provides a similar feature set.
- It does not raise any new issues of safety and efficacy.
Key Differences and Enhancements of JiveX 5.2 compared to JiveX 5.0.6 (predicate device):
The document highlights enhancements in JiveX 5.2, but these are functional and architectural improvements, not related to diagnostic performance metrics:
- Viewing clients: Fused image display, workflow support for manual spine labeling, creation of videos from image series, enhanced performance for loading multi-frame data (especially tomosynthesis).
- System Maintenance: Interface for external software for status monitoring, configuration of web-clients for user groups.
- Healthcare Content Management (HCM) Enhancements: Quality assurance workflow for documents, communication server acts as an integrated XDS source and repository, JiveX Connect module for patient/referring physician connectivity, supports IHE profile Imaging Object Change Management, interface to a 3rd party web viewer for ECG reading (Cordiana DX).
- Technological Characteristics: Updated operating system support for server and client (e.g., Windows Server 2019, iOS 12, 13), enhanced image compression (LZ4), and extended image processing algorithms (e.g., additional interpolation methods like Lanczos, b-spline, and fused display for 3D image processing).
In essence, this document is a regulatory submission for a PACS, focusing on its functional capabilities and safety, rather than its performance in a diagnostic accuracy assessment.
§ 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).