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The EasyVision Workstation Release 6 is an image processing workstation software package designed to run on standard PC hardware. The hardware required is made up of "off-the-shelf" standard computer components. The Easy Vision Workstation Release 6 software receives image data from medical scanning devices, such as CT or MRI, or from image archives and performs viewing, image manipulation, communication, printing and quantification of images.

The device is a software package able to run on "off the shelf" hardware components. The system operating software is a standard Windows XP Professionel operating system. The application software can be divided in view, print, store and link functions. Communication with modalities such as MRI and CT and with archive systems, operates via a standardised DICOM protocol on top of a TCP/IP network.

This 510(k) submission for the Philips EasyVision Workstation Release 6 focuses on demonstrating substantial equivalence to a predicate device rather than presenting a de novo study with specific acceptance criteria and performance data. Therefore, many of the requested sections (e.g., acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) are not explicitly present in the provided document.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable. The document does not describe specific acceptance criteria or quantitative performance metrics for a study to prove the device meets those criteria. The submission is a claim of substantial equivalence to a predicate device.

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

Not applicable. No specific test set or study data is described in this submission. The "test" in this context refers to demonstrating the equivalence in functionality and safety to the predicate device, not in a traditional clinical performance study with a test set of cases.

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

Not applicable. No ground truth establishment or expert review process for a test set is described.

4. Adjudication Method for the Test Set

Not applicable. No test set requiring adjudication is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC comparative effectiveness study is not mentioned or described in the provided document.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No. This device is an image processing workstation software package, which inherently involves human interaction for viewing, manipulation, and quantification. It is not an AI algorithm intended for standalone diagnostic performance.

7. The Type of Ground Truth Used

Not applicable. The submission does not describe a performance study where ground truth would be established for diagnostic accuracy. The ground truth for proving substantial equivalence would be the established functionality and safety profile of the predicate device.

8. The Sample Size for the Training Set

Not applicable. The document does not mention any machine learning or AI components that would require a "training set" in the context of algorithm development.

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

Not applicable. As no training set is mentioned, the method for establishing its ground truth is also not applicable.

Summary of Relevant Information from the Provided Document:

• Device Type: Image processing workstation software package.
• Purpose: Receives image data from medical scanning devices (CT, MRI) or archives, and performs viewing, image manipulation, communication, printing, and quantification of images.
• Intended Use Statement: "The EasyVision Workstation Release 6 is an image processing workstation software package designed to run on standard PC hardware. The hardware required is made up of "off-the-shelf" standard computer components. The Easy Vision Workstation Release 6 software receives image data from medical scanning devices, such as CT or MRI, or from image archives and performs viewing, image manipulation, communication, printing and quantification of images."
• Regulatory Pathway: 510(k) premarket notification.
• Predicate Device: Philips EasyVision Workstation (K920950).
• Substantial Equivalence Claim: The Philips Easy Vision Workstation Release 6 is substantially equivalent to the Easy Vision Workstation systems (K920950).
• Safety Information: "No new hazards are introduced by the development of Easy Vision Workstation Release 6. Hazards known during the lifecycle of the Easy Vision Workstations are again considered and measurements are taken."

In essence, this 510(k) submission is a declaration that the new device has the same intended use, technological characteristics, and safety profile as a previously cleared device, rather than a clinical study evaluating its performance against specific acceptance criteria.

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