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IPACS Medical Image Management Software is used for viewing medical images.

IPACS Medical Image Management Software receives, stores and archives digital images and data from various sources (including but not limited to CT, MR, US, RF units, computed and direct radiographic devices, scanners, imaging gateways or imaging sources). IPACS Medical Image Management Software can be integrated with an institutions existing Hospital Information System (HIS) or Radiology Information System (RIS) for fully integrated electronic patient records.

IPACS Medical Image Management Software can be used to retrieve, process and display medical images and patient information from any connected workstation. Users have access to various image processing and measurement tools to assist them in viewing images. In addition, users can overlay templates on aid in pre-operative planning and annotations and measurements to aid in diagnosis.

Typical users of IPACS Medical Imagement Software are trained medical professionals, including but not limited to radiologists, technologists and clinicians.

The Visbion IPACS (Integrated Picture Archiving and Communications System) Medical Image Management Software is a vendor-neutral PACS (Picture Archiving and Communication System) solution delivering enterprise-wide diagnostic images and patient reports, available for review at any time, from any location using a standard web browser.

IPACS is a single healthcare platform that allows the seamless acquisition of images from multiple types of imaging devices from a range of different equipment suppliers. It is a true clinical repository with the ability to harmonise all departments within a hospital. The approach to connectivity is based on three key standards; Digital Imaging and Communications in Medicine (DICOM) 3.0, Health Level Seven International (HL7) and Integrating the Healthcare Enterprise (IHE).

Using a standard web browser registered users have the ability to log in thus provide secure access to images from diagnostic workstation in hospitals and consulting rooms plus from off-site storage facilities. 24 hours a day.

The device is constructed from the four software elements. These elements are combined according to the configuration required by the user. These terms are used by the user, IPACs being a general term to consolidate the following four elements:

Image Archive
lmage Viewer
Image Web
Image Importer

The provided document is a 510(k) premarket notification for the "IPACS Medical Image Management Software." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving that the device meets specific acceptance criteria through a clinical study. Therefore, the document does not contain the detailed information requested regarding clinical acceptance criteria, study design, sample sizes, expert qualifications, or ground truth establishment.

Instead, it focuses on comparing the technological characteristics of the IPACS Medical Image Management Software to a predicate device, eFilm Workstation with Modules (K020995), to argue for substantial equivalence.

Based on the information provided, here's what can be extracted and what is missing:

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

This information is not available in the provided document. The 510(k) submission is for substantial equivalence, not for demonstrating specific performance metrics against pre-defined acceptance criteria in a clinical study. The "performance" described is a comparison of technical features to a predicate device.

• Type of Device (Software only on PC/server)
• Type and Source of Images (Digital from various modalities)
• Scope of Image Processing (Displays files from DICOM-compliant modalities)
• Display of an Image (Visual display unit, hardcopy to laser printer)
• Processing of an Image (Interactive positioning, sizing, rotation, contrast/brightness adjustment)
• Means of Collecting Data (From pre-obtained digital images)
• Processing of Data (Processes data, indicates quality loss, lossless storage)
• Standards Compliance (DICOM 3.0, JPEG Standard, HL7, IHE)
• Stand-alone Software (Yes)
• Can be used on Multiple Hardware Platforms (Yes, with min. requirements)
• Transmit Images to Remote Viewing Stations Over an Imaging Network (Yes) |

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

This information is not available. The document describes a comparison of device characteristics, not a clinical study with a test set of data.

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)

This information is not available. No test set or ground truth established by experts is described for this 510(k) submission.

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

This information is not available. No test set or adjudication method 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

This information is not available. The device (IPACS Medical Image Management Software) is a Picture Archiving and Communications System (PACS) for viewing, storing, and archiving medical images with basic processing and measurement tools. It is not an AI-assisted diagnostic device, and therefore, an MRMC comparative effectiveness study regarding "human readers improve with AI vs without AI assistance" would not be relevant to this specific product.

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

This information is not applicable/not available in the context of this device. The IPACS is a software platform intended for use by "trained medical professionals, including but not limited to radiologists, technologists and clinicians" for viewing and managing images. It is not an algorithm that provides a standalone diagnostic output. Its performance is defined by its ability to receive, store, process, and display images, and its technological equivalence to a predicate PACS.

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

This information is not available as no clinical study involving ground truth establishment is described. The "ground truth" in this context is implicitly the functionally comparable performance of the predicate device.

8. The sample size for the training set

This information is not available. The device is not an AI/ML algorithm that requires a "training set" in the conventional sense for medical image analysis. It is image management software.

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

This information is not available as no training set or ground truth establishment for a training set is described.

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MedCommons Open Radiology™ Gateway (MedCommons Gateway™) is a software application for viewing medical images. Typical MedCommons Gateway™ users are healthcare professionals, such as, clinicians, radiologists, and technologists.

MedCommons Gateway™ receives, communicates, and displays digital images and data from various types of imaging and image processing system, such CT, MR, US, RF units, computed and direct radiographic devices, scanners, imaging gateways and image processing sources). MedCommons Gateway™ can be integrated with an institution's HIS or RIS, linking or transferring images and data into electronic patient records.

MedCommons Open Radiology™ Gateway (MedCommons Gateway™) is a component of a Picture Archiving and Communications System (PACS). MedCommons Gateway™ is a software application that provides image viewing and manipulation in a diagnostic imaging setting. The functions of this application are applied to medical images that are acquired and stored on an image server in DICOM and/or other proprietary formats. MedCommons Gateway™ can also transfer DICOM 3.0 images over a medical imaging network, as well as export images to applications in JPEG and/or proprietary formats.

The provided text is a 510(k) summary for the MedCommons Open Radiology™ Gateway. This document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria.

The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device (eFilm Workstation) based on device description, intended use, and similar features. It is a regulatory submission for market clearance, not a report of a performance study with specific acceptance criteria.

Therefore, I cannot provide the requested table and study details. The document explicitly states:

• Substantial Equivalence: The MedCommons Open Radiology™ Gateway is substantially equivalent to the eFilm Workstation, which was cleared in 510(k)'s K020995 and K012211.
• Comparison to the predicate device: The MedCommons Open Radiology™ Gateway and the eFilm Workstation are both software applications intended for viewing medical images stored in PACS systems. They have similar features and are substantially equivalent in safety and effectiveness.

This indicates that the clearance was based on similarity to an already approved device, rather than a new clinical performance study with defined acceptance criteria and subsequent testing against them for this specific device.

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