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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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