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This device is intended for use when there is a need to convert endoscopic and microscopic surgical video to a digital video format for subsequent review and archiving. This device will also transfer the digital video over digital networks and/or digital communication lines.

fyreLINK VL (formerly echoLINK) now provides the endoscopy and surgical market a real-time solution for dealing with video data in a complete image management system. There are three major components that make up the fyreLINK VL product line; an image acquisition unit, a review station (either the fyreLINK station or a third party product), and a DVD library system or other archive device. The telemedicine system uses the same components except for the DVD library system. Appendix D shows an example of how an image acquisition unit can be arranged to provide a particular customer solution.

The fyreLINK VL Image Acquisition Unit (IAU) is the key component of the fyreLINK VL device. It uses a hardware video converter to convert analog video coming from a surgical video system to streaming digital video in real time. This streaming digital video is then compressed using MPEG 2 technology and stored on its local hard drive as a MPEG2 file. The IAU can store up to 1000 minutes of digital video data on its internal hard disk. The data is available for immediate review on the IAU, or can be exported to another application or another workstation or archive. Each acquired recording is an individual file. Exams can consist of a single continuous recording of the entire procedure, or a collection of shorter recordings of areas of interest. Still images may also be captured and saved as bitmap or JPEG files. 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 existing VCR's used in endoscopic and microscopic surgical procedures. The IAU platform can consist of either a laptop or desktop type computer. The device has an electronic report generator that will allow the user 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 telemedicine system. The IAU is controlled by MPACS proprietary software.

fyreLINK VL 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 VL SOFTWARE LABELS ALL RECALLED IMAGES WITH THE TYPE OF COMPRESSION USED AND THE COMPRESSION RATIO.

fyreLINK VL used in a network environment can integrate with a mass archive solution already in place. As an alternative, the IAU includes a DVD recorder built in, to permit immediate local archival of endoscopic or microscopic surgical procedures.

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

The provided documentation (K030728) is a 510(k) Summary for the fyreLINK VL device, which is a Picture Archiving and Communications System (PACS). This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with specific acceptance criteria and performance metrics for the fyreLINK VL itself.

Therefore, many of the requested sections about specific acceptance criteria, performance studies, sample sizes, expert ground truth establishment, and reader studies are not applicable as this type of information is not typically included in a 510(k) summary for a PACS device demonstrating substantial equivalence. The FDA submission for this type of device primarily relies on demonstrating that its technological characteristics and intended use are similar to a legally marketed predicate device.

Here's an analysis based on the available information:

Acceptance Criteria and Study for fyreLINK VL (K030728)

The submission for the fyreLINK VL device is a 510(k) Premarket Notification, which seeks to demonstrate substantial equivalence to a legally marketed predicate device, the Dyonics Vision 635 Digital Capture System (K011944). For this type of submission, the "acceptance criteria" are generally met by demonstrating that the new device has the same intended use and similar technological characteristics, and that any differences do not raise new questions of safety or effectiveness. Specific quantitative performance metrics with pre-defined acceptance criteria, as would be seen in a clinical trial or performance study for a diagnostic algorithm, are not typically provided or required in such a submission for a PACS system.

1. Table of Acceptance Criteria and Reported Device Performance

As a substantial equivalence submission for a PACS device, the "acceptance criteria" are implicitly met by demonstrating technological equivalence and equivalent intended use with the predicate device. There are no explicit quantitative performance metrics or a table of acceptance criteria presented in this 510(k) Summary.

The key reported performance claims are:

• Acquisition/Digitization: Converts analog video to streaming digital video (MPEG 2) in real-time (30 frames per second).
• Storage: Stores up to 1000 minutes of digital video data on its local hard drive.
• Playback: Plays back stored digital video in real-time.
• Export: Exports data files in DICOM format and still images as bitmap or JPEG files.
• Compression Labeling: The review function of fyreLINK VL software labels all recalled images with the type of compression used and the compression ratio.

The "study that proves the device meets the acceptance criteria" is the comparison of technological characteristics and intended use to the predicate device.

2. Sample Size Used for the Test Set and Data Provenance

Not applicable. This 510(k) submission does not describe a clinical performance study with a test set of data. The submission focuses on technical specifications and comparison to a predicate device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

Not applicable. No ground truth establishment by experts for a test set is described in this submission.

4. Adjudication Method for the Test Set

Not applicable. There is no test set or adjudication method described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. No MRMC study is described. The device is a PACS system for managing video data, not a diagnostic AI algorithm that would typically undergo such a study to assess human-AI collaboration.

6. Standalone (Algorithm Only) Performance Study

Not applicable. The fyreLINK VL is a hardware and software system for video acquisition, storage, and review, not an AI algorithm for standalone diagnostic performance. Its functionality is described in terms of its ability to process and manage video data effectively, mirroring the predicate device.

7. Type of Ground Truth Used

Not applicable. The submission does not involve ground truth in the context of diagnostic accuracy. The "truth" for this device lies in its ability to accurately digitize, store, and playback video as described by its technical specifications and demonstrated by its equivalence to the predicate.

8. Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm that requires a training set in the conventional sense for a diagnostic model.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As above, there is no training set for an AI/ML model.

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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.

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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 analog 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.

EchoLINK provides a telecardiology system, a complete image management system, and a stress echo acquisition and measurement system. There are four major components that make up the EchoLINK device; an image acquisition unit, a review station, a CDR library system, and the networking components.

The EchoLINK image acquisition unit (IAU) uses MPEG2 technology to convert analog video coming from the ultrasound machine to digital video in real time. The IAU can store up to 130 minutes of digital video data on its internal hard disk or 20 minutes on a removal digital storage device. The data storage format is in standard WindowsNT or DICOM 3. The IAU employs user-defined protocols for view indexing. The IAU allows for the placement of time markers within a view to identify the start and end of systole (necessary for stress echo applications) and allows the user to measure left ventricular function. The IAU is network-ready for transferring patient data to a central CDR library system and/or to a physician's review station. The EchoLINK device has an electronic report generator that allows the sonographer and physician to enter exam information as part of a paperless reporting system.

The EchoLINK device, when equipped with an optional modem or ISDN interface, can be remotely accessed to provide a variety of telecardiology solutions. The device is controlled by MPACS proprietary software.

The provided text does not contain any information about acceptance criteria or a study proving the device meets those criteria.

The document is a 510(k) summary for a medical device called EchoLINK, focusing on its substantial equivalence to previously marketed devices. It describes the device's functionality, its intended use, and a comparison with predicate devices.

Therefore, I cannot provide the requested table or answer the specific questions about acceptance criteria and performance studies based on the given input.

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