Search Results

This device is intended for use by health care professionals trained in the field of echocardiography or medical ultrasound. It is to be used when there is a need to convert ultrasound video to a digital video format for subsequent review and archiving. This device is also intended for use in transferring ultrasound images over digital networks and/or digital communication lines.

fyreLINK (formerly echoLINK) now provides the cardiology ultrasound market a realtime solution for dealing with EC data, a telecardiology system, a complete image management system, and stress echo acquisition with LV function, M-mode, and Doppler measurements. There are four major components that make up the fyreLINK product line; an image acquisition unit, a review station, a DVD library system, and the networking configuration. The telecardiology system uses the same components except for the DVD library system. Appendix D shows several examples of how these components can be arranged to provide customer solutions.

The fyreLINK image acquisition unit (IAU) is the key component of the fyreLINK device. It uses a hardware video converter to convert analog video coming from the ultrasound machine to streaming digital video in real time. This streaming digital video can then be compressed using MPEG 2 or a lossless compression technique (run-length encoding), and stored on the local hard drive as an MPEG2 or an AVI file. The IAU can store up to 1000 minutes of digital video data on its internal hard disk if MPEG2 compression is used, or 30 minutes if lossless compression is used... The data is available for immediate review on the IAU, or can be exported to another application or another workstation or archive. The IAU employs user-defined protocols for view indexing. Each acquired view is an individual file. The IAU allows the user to place time markers within a view to identify the start of systole (the contraction phase of the heart). This intra-view marking is necessary for stress echo applications. The IAU is built on a Windows 2000 platform, and is network-ready for transferring patient data to a local or central archive system and/or to a physician's review station. The IAU's compact size allows it to be a direct replacement for the ultrasound machine's existing VCR. The IAU platform can consist of either a laptop or desktop type computer. The device has an electronic report generator that will allow the sonographer and physician to enter exam information as part of a paperless reporting system. The IAU, when configured as part of a WAN environment, can be a part of a remote access telecardiology system. The IAU is controlled by MPACS proprietary software.

fyreLINK offers two review station solutions. Acquired images can be reviewed at the IAU, or the image files can be exported for use with another application. THE REVIEW FUNCTION OF FYRELINK SOFTWARE LABELS ALL RECALLED IMAGES WITH THE TYPE OF COMPRESSION USED AND THE COMPRESSION RATIO.

fyreLINK used in a network environment can integrate with a mass archive solution already in place. As an alternative, the IAU includes a CD-R recorder built in, to permit immediate local archival of ultrasound studies. CD-R recorders can also be added to customer review stations.

MPACS will supply network solutions for integrating the fyreLINK components. In a network configuration, the image acquisition unit moves patient studies directly to a server. The review station is able to review both on-line and near-line studies. Network solutions will also include telecommunication links such as T1, ISDN, and modem connections for telecardiology.

I am sorry, but the provided text does not contain information about acceptance criteria or a study proving that a device meets such criteria.

The document is a 510(k) summary for a PACS device called "fyreLINK." It focuses on:

• Device identification details: Name, manufacturer, classification, product code.
• Description of the device: Its components, functionality (image acquisition, compression, storage, networking, review), and software.
• Intended use: Converting ultrasound video to digital format for review and archiving, and transferring images over networks.
• Substantial equivalency comparison: How fyreLINK is similar to existing legally marketed devices (echoLINK, EnConcert, TomTec'99), highlighting minor technological differences that do not affect safety or effectiveness. This is the core of a 510(k) submission, demonstrating that the new device is as safe and effective as a predicate device.
• FDA correspondence: The letter from the FDA stating that the device is substantially equivalent and can be marketed.

Therefore, I cannot extract the requested information (acceptance criteria, study details, sample sizes, expert qualifications, ground truth, etc.) because it is not present in the provided text. The document does not describe performance targets, clinical studies, or methods for evaluating the device's accuracy or effectiveness in a quantitative manner. Its purpose is to establish substantial equivalence for regulatory clearance, not to report on a performance study against specific acceptance criteria.

Ask a specific question about this device