Search Results

SonoView Pro™ by Medison Co. Ltd. is a software application for the display and 3D visualization of medical image data derived from various sources (i.e. Ultrasound, CT scanners, MRI scanners). Images and data can be acquired, stored, communicated, processed, printed, rendered, and displayed within the system and or across computer networks at distributed locations. Typical users of this system are trained professionals, including physicians, nurses, and technicians.

SonoView Pro™ is an Internet based software picture archiving and communications system that provides users with capabilities relating to the acceptance, transfer, display, storage, and digital processing of medical images. SonoView Pro™ includes features to access and manage medical imaging studies from ultrasound (US), cat-scan (CT), magnetic radiography (MR), nuclear medicine (NM), computerized radiography (CR), digital radiography (DR), digital x-ray (DX), x-ray angiography (XA), PET scan (PT), and other imaging modalities. SonoView Pro™ is deployed over conventional TCP/IP networking infrastructure available in most healthcare organizations and utilizes commercially available computer platforms (Intel Pentium-based) and operating systems (Microsoft Windows 2000/XP). The system does not produce any original medical images. All images located on SonoView Pro™ have been received from DICOM compliant imaging modalities and/or PACS components or systems. SonoView Pro™ provides the advanced process functions, such as : - Supports the freehand scanning, 3D image acquisition, and 3D reconstruction. - Acquires images from ultrasound system in real time. - -Supports the ultrasound image storage and ultrasound multi-frame image storage. - Supports the GUI functions: zoom, pan, pseudo-color setting, threshold setting, -Gamma correction, and thumbnail. - -Provides the DICOM query and retrieve services (images and presentation states). - -Displays the cut planes of 3D image along the long axis or the short axis. - Provides 3D rendering modes: MIP, X-ray, translucent, surface, slicing, and 3D cine. - -Supports distance/area/angle measurements. - Supports Tele-medicine (audio, video, and text) between regional medicine center and remote clients.

This 510(k) summary does not contain the information requested regarding acceptance criteria or a study proving that the device meets such criteria.

The document is a 510(k) premarket notification for a Picture Archiving Communications System (PACS) software called SonoView Pro™. It describes the device, its intended use, and its technological characteristics, and asserts substantial equivalence to a predicate device.

Here's why the requested information is not present:

• Type of Device: SonoView Pro™ is a PACS software, essentially an image management and display system. It is not an AI/ML medical device that performs diagnostic interpretations or measurements which would typically require performance metrics like sensitivity, specificity, or accuracy compared to a ground truth.
• Regulatory Pathway: The 510(k) pathway for this type of device primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device in terms of intended use, technological characteristics, and safety and effectiveness. It typically doesn't involve the rigorous performance validation studies (like those with acceptance criteria, ground truth establishment, expert adjudication, or MRMC studies) that are common for AI/ML diagnostic algorithms.
• Date: The submission date is May 5, 2003. At this time, AI/ML in medical devices was nascent, and regulatory expectations for performance validation of such algorithms were very different, if they existed at all in the current form.
• Content of the Summary: The summary explicitly states it "contains adequate information and data to enable FDA - CDRH to determine substantial equivalence to the predicate device" and that "potential hazards have been classified as Minor." This points to a focus on safety, basic functionality, and equivalence rather than a detailed performance study with quantitative acceptance criteria.

Therefore, the provided document does not allow for a response to the following specific points:

1. A table of acceptance criteria and the reported device performance
2. Sample sized used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
4. Adjudication method
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
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

In summary, the provided 510(k) focuses on demonstrating equivalence for a PACS system, not on proving diagnostic performance against specific acceptance criteria for an AI/ML algorithm.

Ask a specific question about this device