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The ImageView™ Coronary Angiography Display and Review System is a computer program which can be used to view the results of an X-ray cardiac angiography procedure on a personal computer workstation. The digital image record of the X-ray exposures made during a catheterization procedure can be retrieved from a compact disk (CD) and displayed on a computer workstation monitor. ImageView™ also allows the user to change the appearance of the images and export selected frames to other programs for printing and further manipulation.

The ImageView™ Coronary Angiography Display and Review System is an angiographic image review software program. It is provided on a 3½-inch 1.44 MB floppy disk. The disk contains the installation program, ImageView™ executable files, a Readme file and Dynamic Link Library files. ImageView™ is designed to read and display angiographic images which have been stored using the DICOM 3.0 format for medical images.

Here's an analysis of the provided text regarding the ImageView™ Coronary Angiography Display and Review System, focusing on acceptance criteria and supporting studies.

Based on the provided 510(k) summary for the ImageView™ Coronary Angiography Display and Review System, no specific acceptance criteria or an explicit study proving the device meets quantitative performance metrics are detailed. The document primarily focuses on establishing substantial equivalence to predicate devices based on intended use and technological characteristics, rather than presenting a performance study with defined criteria.

Here's a breakdown of the requested information, indicating where the document lacks specific details:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable. The document does not describe specific quantitative acceptance criteria (e.g., accuracy, sensitivity, specificity, processing speed thresholds) for the ImageView™ system, nor does it report numerical device performance against such criteria. The basis for substantial equivalence is functional similarity.

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

Not specified. The document does not mention any test set or data used for performance evaluation beyond general statements about "reading and displaying angiographic images." Therefore, sample size and data provenance are unknown.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. The concept of "ground truth" and expert consensus for a performance study is not discussed, as no such study is presented.

4. Adjudication Method for the Test Set

Not applicable. There is no mention of a test set requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. The document does not indicate that an MRMC comparative effectiveness study was performed, nor does it quantify any effect size of AI astounding human readers. The device is a display and review system, not an AI-powered diagnostic tool in the sense of providing automated interpretations.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop)

Not applicable. As the device's primary function is to display and allow user manipulation of images, the concept of a "standalone" algorithm performance in the typical diagnostic sense (e.g., detecting disease independently) does not apply. The device's performance is intrinsically linked to its functionality as a display and review tool for human operators.

7. Type of Ground Truth Used

Not specified. Since no performance study is described, there's no mention of the type of ground truth used.

8. Sample Size for the Training Set

Not applicable. The document describes a software program for display and review, not a machine learning model that would typically require a training set.

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

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

Summary of the Device's Basis for Approval:

The ImageView™ Coronary Angiography Display and Review System received 510(k) clearance based on substantial equivalence to existing predicate devices (DICOMview™ and Kodak Digital Science Cardiac Review Station CRS 2000). The arguments for substantial equivalence are:

• Intended Use: The ImageView™ system shares the same general intended use as the predicate devices: to view and manipulate angiographic images from X-ray cardiac angiography procedures on a personal computer workstation.
• Technological Characteristics: The functional performance is comparable, both using graphical user interfaces to display and review DICOM image records, and both accessing images from a DICOM CD.

The 510(k) process for this type of device in 1997 focused on demonstrating that the new device introduced no new questions of safety or effectiveness compared to legally marketed predicate devices, rather than requiring extensive quantitative performance studies for a display and review system.

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