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ViewPoint 6 is intended to be used in medical practices and in clinical departments and serves the purposes of diagnostic interpretation of images, electronic documentation of examinations in the form of text and images, and generation of medical reports primarily for diagnostic ultrasound.

ViewPoint 6 provides the user the ability to include images, drawings, and charts into medical reports. ViewPoint 6 is designed to accept, transfer, display, calculate, store, and process medical images and data, and enables the user to measure and annotate the images. The medical images, which ViewPoint 6 displays to the user, can be used for diagnostic purposes.

ViewPoint 6 is intended for professional use only. ViewPoint 6 is not intended to be used as an automated diagnosis system.

ViewPoint 6 is not intended to operate medical devices in surgery related procedures.

ViewPoint 6 is an image archiving and reporting software for medical practices and clinical radiological departments. It is used for diagnostic interpretation of images and other data. ViewPoint 6 is for professional use only and enables quick diagnostic reporting with standardized terminology. It has an intuitive graphical user interface (GUI) and is based on Microsoft Windows® with defined hardware requirements for the user to install on their computer.

ViewPoint 6 provides exam type specific reporting forms for various medical care areas. Forms are composed of different sections with data entry fields. The documentation can include measurements, exam findings, images, and graphs. All data is saved in the ViewPoint 6 database and can be compiled to a professional report. Images and image sequences can be reviewed in the ViewPoint 6 display area based on user preference.

ViewPoint 6 supports both a single workstation and a client-server setup. The number of user licenses determines how many workstations in the network have concurrent access to the database. Access can be limited to read-only functionality.

The provided text does not contain information about acceptance criteria and a study proving a device meets these criteria. Instead, it is a 510(k) premarket notification for a medical device called "ViewPoint 6." This document primarily discusses the device's indications for use, its substantial equivalence to a predicate device, and the non-clinical tests performed to ensure compliance with relevant standards.

Specifically, the document states: "The subject of this premarket submission, ViewPoint 6, did not require clinical studies to support substantial equivalence." This means that no clinical study was conducted to demonstrate the device's performance against specific acceptance criteria.

Therefore, I cannot provide the requested information, including:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set and data provenance.
3. Number of experts used for ground truth and their qualifications.
4. Adjudication method for the test set.
5. MRMC comparative effectiveness study results.
6. Standalone performance results.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

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