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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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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, 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 describes a 510(k) premarket notification for the JiveX (Model Number / Release: 5.3) Picture Archiving and Communication System (PACS).

Please note: The document explicitly states that the "subject device was found to have a safety and effectiveness profile that is similar to the predicate device" based on non-clinical performance testing. It also outlines verification and validation activities throughout development. However, the document does not contain details of specific acceptance criteria (numerical targets) or the results of a dedicated study to "prove" the device meets such criteria in comparison to a predicate device. The submission primarily focuses on demonstrating substantial equivalence to a predicate device (JiveX 5.2) without reporting a comparative clinical effectiveness study against specific performance metrics for the new release.

Therefore, many of the requested details related to quantitative acceptance criteria, a specific study proving those criteria, sample sizes used for test sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, or standalone performance are not available in the provided text.

Here's a breakdown of what can be extracted based on the provided information:

1. A table of acceptance criteria and the reported device performance

As mentioned above, the document does not provide a table of explicit, quantifiable acceptance criteria or reported numerical performance data from a specific study comparing the subject device to a predicate device against such criteria. The "Performance Data" section describes the verification and validation process rather than specific performance metrics and their achievement.

The conclusion states: "Based on the non-clinical performance testing the subject device was found to have a safety and effectiveness profile that is similar to the predicate device."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not provided in the document. The "Performance Data" section describes general verification and validation activities but does not specify the sample sizes, data provenance, or study design (retrospective/prospective) for any test sets used to compare performance between the subject and predicate device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not provided in the document. No specific "test set" with expert-established ground truth is detailed.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not provided in the document.

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

The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. This device is a PACS system, which primarily focuses on image management and display, and not an AI-assisted diagnostic tool that would typically involve improving human reader performance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is a PACS system, a software only medical device (SaMD) for image management, display, and processing. It does not appear to be an algorithm designed for standalone diagnostic performance. The document focuses on its functions as an archiving and communication system, supporting physicians in diagnosis.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not provided and not applicable given the nature of the device and the information presented. The document does not describe studies requiring "ground truth" for diagnostic accuracy.

8. The sample size for the training set

Not applicable. This is a PACS system, not a device that relies on a specific "training set" for an AI algorithm in the traditional sense of machine learning for diagnostic tasks. Its development involves software engineering principles and testing, not AI model training.

9. How the ground truth for the training set was established

Not applicable as there is no mention of a training set or AI model development in the provided text.

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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. 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.

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. 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:

• 1. 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.
• 2. 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.
• 3. 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.

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 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.

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