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ProSolv® Echo is stand-alone software that operates on standard PC equipment. The device is available in three configurations (EchoViewer, EchoViewer SE, and EchoAnalyzer) and is intended for use by echocardiographic labs. ProSolv® EchoViewer is also intended for use by cardiac catheterization labs. ProSolv® Echo incorporates the latest technology in archiving, viewing, measuring, and reporting digital echocardiographic studies generated by a multitude of ultrasound manufacturers. The device configurations can be packaged with ProSolv® EchoServer to extend the capabilities for laboratories wanting to access a remote, secure database and archive images over the Internet.

The ProSolv® Echo software operates on a PC computer using the Windows 95/98/NT operating system. ProSolv® EchoViewer allows the user to view echocardiographic and cardiac catheterization images from a variety of sources, track examinations and patient data with a database, and view reports. DICOM images and most non-DICOM images can be read by the software. ProSolv® EchoViewer SE adds to the EchoViewer by including Stress Echo regional wall motion analysis, qualitative image evaluation with a customizable comment list, and report generation. ProSolv® EchoAnalyzer includes all the functionality of EchoViewer SE, plus quantitative image evaluation, routine regional wall motion scoring, and customizable reports and measurements. Each of the products can be packaged with the optional ProSolv® EchoServer capability to allow remote database access via the Internet.

I am sorry, but the provided text does not contain information about specific acceptance criteria or a study that details the device's performance against such criteria. The document is a 510(k) summary for a medical device (ProSolv® Echo), which primarily focuses on establishing substantial equivalence to predicate devices rather than providing detailed performance study results.

The document discusses:

• Device Description: The functionalities of ProSolv® EchoViewer, EchoViewer SE, EchoAnalyzer, and EchoServer.
• Indications For Use: The intended uses of the device in echocardiographic and cardiac catheterization labs.
• General Safety and Effectiveness Concerns: A general statement about hazard concerns and operating instructions.
• Substantial Equivalence: A comparison of features with predicate devices (HP 5500 Sonos (EnConcert software) and Digisonics' Doctor Review System (DigiView System)) to assert that technological differences do not affect safety or effectiveness.
• Conclusions: Reiteration of the device's capabilities and its substantial equivalence to predicate devices.

There is no mention of:

1. Specific acceptance criteria for the device's performance (e.g., accuracy, sensitivity, specificity, speed).
2. A detailed study demonstrating the device meets any particular performance metrics.
3. Sample sizes for test or training sets.
4. Data provenance, expert qualifications, adjudication methods, or ground truth establishment.
5. Comparative effectiveness studies (MRMC) or standalone algorithm performance.

Therefore, I cannot generate the requested table or answer the specific questions about performance studies.

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