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The product is an image processing workstation software package designed to run on standard PC hardware. The hardware is all "off-the-shelf" standard supplied by and may be purchased independently by the end user or from AccuImage. The AccuImage, AccuView Diagnostic Imaging Workstation Software Package with Plug-ins receives image files from medical scanning devices, such as CT or MRI and performs real time viewing, image manipulation, 3D and 4D visualization, communication, and archiving.

The AccuView Diagnostic Imaging Workstation Software Package with Plug-ins receive image files from medical scanning devices, such as CT or MRI and performs real-time viewing, image manipulation, three and four dimensional visualization, communication, and archiving. All of the functions are supported on standard communication, and them for ease of cost and maintenance. The use of Microsoft Windows 95/98/NT operating system makes the AccuView Diagnostic Imaging Workstation Software Package with Plug-ins easy to use and capable of being integrated with other computer needs.

This document is a 510(k) Summary for the AccuView Diagnostic Imaging Workstation Software Package with Plug-ins. It is a pre-market notification to the FDA to demonstrate substantial equivalence to legally marketed devices. As such, it describes the device and its intended use but does not include detailed acceptance criteria or a study proving the device meets those criteria in the way a performance study report would.

Here's an analysis based on the provided text, highlighting what is included and what is not:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the document. The 510(k) summary focuses on demonstrating substantial equivalence to predicate devices based on functional comparisons and technical specifications rather than quantitative performance metrics against predefined acceptance criteria. The tables provided compare the features and technical specifications of the AccuView components with their respective predicate devices.

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

This information is not provided. As this is a 510(k) submission for a diagnostic imaging workstation software package, the focus is on functional equivalence and safety, not on a clinical performance study with a test set of patient cases.

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

This information is not provided. No clinical performance study is described that would involve expert review and ground truth establishment.

4. Adjudication Method for the Test Set

This information is not provided as there is no described test set or clinical performance study.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This information is not provided. The device is an imaging workstation and software package, not an AI-assisted diagnostic tool in the sense of providing automated interpretations or aiding human readers in a way that would be assessed by an MRMC study measuring reader improvement.

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

This information is not provided. The device is a workstation for human interpretation and manipulation of medical images; it's not a standalone algorithm for diagnosis.

7. The Type of Ground Truth Used

This information is not provided as no clinical performance study requiring ground truth is described.

8. The Sample Size for the Training Set

This information is not provided. The document describes software development and testing procedures but not the training of a machine learning model, which would involve a training set.

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

This information is not provided as no training set for a machine learning model is mentioned.

Summary of what is present in the document relevant to device description and regulatory process (but not detailed performance outcomes):

The document outlines:

• Device Name: AccuImage Diagnostics Corporation, AccuView Diagnostic Imaging Software Package with AccuScore, AccuAnalyze, AccuScope, AccuShade, AccuVRT and AccuMIP Plug-ins.
• Intended Use: Receives image files from medical scanning devices (CT or MRI) and performs real-time viewing, image manipulation, three and four dimensional visualization, communication, and archiving.
• Software Development and Testing: "AccuImage Diagnostics Corporation certifies that the AccuView Diagnostic Imaging Workstation Software Package with Plug-ins are designed, developed, tested and validated according to written procedures." These procedures cover product specifications, coding, testing, validation testing, and field maintenance.
• Hazard Analysis: Performed throughout the definition, design, coding, and testing phases. Concluded that the "Level of Concern" is "Minor," as failures are primarily related to computer system components and "None of these failures are expected to materially contribute to patient death or injury."
• Substantial Equivalence: Demonstrated by comparing the device's characteristics and functions (e.g., computer platform, communication, image format, display, processing, specific plug-in functionalities like calcium scoring, and virtual endoscopy) against predicate devices (AIDP, Imatron Ultra Access, InSight Diagnostic Imaging Workstation, and Picker Voxel Q/Voyager) via detailed tables. This comparison forms the basis of the FDA's clearance, indicating that the new device is as safe and effective as existing legally marketed devices.

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