The RadWorks™ Medical Imaging Software is a medical device, and it has the same indications for use and target population as the legally marketed predicate devices.

Device Description

The RadWorks™ medical imaging software consists of a basic module, RadWorks™ Review, and a number of optional modules, to enable the radiologist to view, retrieve, store, import process and transmit medical images. The RadWorks™ software is an open system which runs under the Microsoft® Windows NT™ operating system and it can operate on any hardware platform which meets the minimum hardware requirements and which supports the Windows NTT™ operating system. Windows NT™ based workstations can be made part of UNIX, Novell NetWare, or other networks from major vendors. RadWorks™ is a stand-alone software product and involves no hardware except (optionally) a special graphics card.

AI/ML Overview

The provided document is a 510(k) Summary for the RadWorks™ Medical Imaging Software, dated July 5, 1996. It describes the device, its intended use, and argues for its substantial equivalence to predicate devices. However, it does not include specific acceptance criteria or an explicit study proving the device meets those criteria in the modern sense of a performance study with quantitative metrics.

The document states: "The RadWorks™ Medical Imaging Software is tested according to the specifications that are documented..." and "The RadWorks™ Medical Imaging Software is tested according to the Specifications national of the Research and the former as in a Software Safe ware In a Software Test Plant Quality Handbook." This implies that internal specification testing was performed, but the results of such testing are not detailed, nor are specific acceptance criteria for performance metrics (like sensitivity, specificity, accuracy, etc.) provided.

Therefore, many of the requested fields cannot be answered from the provided text.

Here's a breakdown of what can be inferred or what is explicitly missing:

1. Table of acceptance criteria and the reported device performance:

Acceptance Criteria	Reported Device Performance
Not specified in this document. The document mentions testing "according to specifications" but does not define these specifications or report performance metrics against them.	Not specified in this document.

2. Sample size used for the test set and the data provenance:

Sample size for test set: Not specified.
Data provenance: Not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable, as no ground truth establishment for a test set is described.

4. Adjudication method for the test set:

Not applicable, as no ground truth establishment for a test set is described.

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:

No, an MRMC comparative effectiveness study is not described. The document pertains to a general medical imaging software (digital image communication system) rather than an AI-assisted diagnostic tool.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

The device is a "stand-alone software product" in the sense that it operates independently and is described as a "Digital Image Communications System" for viewing, retrieving, storing, processing, and transmitting medical images. This is distinct from a standalone diagnostic algorithm performance study. The document does not describe a standalone performance study for an algorithm in a diagnostic context.

7. The type of ground truth used:

Not applicable, as no ground truth for a diagnostic performance study is described.

8. The sample size for the training set:

Not applicable, as this device (a digital image communication system) is not described as involving a training set in the context of machine learning.

9. How the ground truth for the training set was established:

Not applicable, as this device is not described as involving a training set in the context of machine learning.

Summary of what the document does provide regarding testing:

General Statement on Testing: "The RadWorks™ Medical Imaging Software is tested according to the specifications that are documented... in a Software Test Plan and Quality Handbook."
Purpose of Testing: To assure "substantial equivalence" to predicate devices.
Focus of the Device: It is a digital image communication system for viewing and managing medical images, offering features like interactive windowing, zooming, panning, annotation, measurement, and connectivity. It is not presented as an AI-powered diagnostic tool requiring performance metrics like sensitivity or specificity against a ground truth for lesions or conditions. Its "performance" would likely be related to functional correctness, image quality preservation, speed of display, and adherence to display standards.

Summary

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5 July, 1996

K962699

510(k) Summary

RADWORKS™ MEDICAL IMAGING SOFTWARE

Common/Classification Name: Digital Image Communications System

Applicare Medical Imaging B.V. P.O.Box 416 2400 AK Alphen aan den Rijn The Netherlands Tel: (+31) 172 449 111 Fax: (+31) 172 449 129 E-mail: R.Kroon@applicare.nl

Contact: Ruud Kroon Prepared: July 5, 1996

LEGALLY MARKETED PREDICATE DEVICES A.

The RadWorks™ Medical Imaging Software is substantially equivalent to the ICON Teleradiology System by ICON Medical Systems (K911752), and the Images-on-Call Teleradiology System by Devices and Services Company (K896095).

DEVICE DESCRIPTION B.

Section II of this submission contains a detailed description of the RadWorks™ Medical Imaging Software. The present section is intended as a summary. RadWorks™ is a stand-alone software product.

Introduction

The basic component: RadWorks™ Review

RadWorks™ Review can display any digital monochrome image from CT, MRI, CR and US. Its built in colour option (using auto detect) also enables the display of 24-bit true colour images. This turns any RadWorks™ system into a true multi-modality workstation that can handle images not only from the Radiology department, but also from Endoscopy, Gastroscopy and other colour (video) sources.

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Applicare Medical Imaging B.V.

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In monochrome mode, RadWorks™ Review offers features that are used routinely by radiologists and other medical specialists:

· Interactive windowing and an unlimited number of user definable pre-set window level buttons.
· Zooming up to 4 times using fixed settings or flexible zooming using a magnifying glass.
· A 'magic glass' with filtering and edge enhancement.
· A grev scale invert option.
Interactive panning of zoomed images. .
Adjustable (multiple) cine loops for multiple image series. .
Annotation using markers and text. .
Measurement of pixel values, angles and distances. .
Histograms of pixel distribution along given lines and statistics of flexible regions of interest (ROIs). .

Fully configurable layout of viewports, toolbar positioning and a report option for text comments. . In colour mode, the images can be zoomed and panned.

Connections to the outside world

RadWorks™ can obtain data from various sources. Video images can be frame grabbed, using the Frame Grabber Module. Non DICOM 3.0 digital signals (ACR-NEMA 1.0 or 2.0 or proprietary) can be converted using Conversion Modules. Existing film and accompanying documents can be digitized and scanned using the Digitizer Module and the Document Scanning Module. Information from sources outside the hospital or from other departments can be received using (transparent) teleradiology over the hospital network, using conventional telephone lines, ISDN, T1 and ATM lines or satellite communications. In a departmental network or PACS any RadWorks™ station can open views on DICOM 3.0 compliant archives or other DICOM 3.0 compliant or RadWorks™ viewing stations and perform query and retrieve actions.

The other RadWorks™ modules

In addition to the basic viewing by RadWorks™ Review and the acquisition modules (Frame Grabbing, Digitizing/Document Scanning and Conversion), the RadWorks™ product line has many other modules available.

The Teleradiology Module provides high quality digital images in a well controlled and protected process. Teleradiology send and receive are taking place in the background, thus allowing for the continuation of viewing and reporting. Lossless compression is available, but also industry standard (DICOM) JPEG compression.

The MPR/MIP module offers high speed Multi Planar Reconstruction and Maximum Intensity" Projection.

The Study Compare option allows for opening various studies simultaneously for comparison.

The Print Module supports DICOM 3.0 printing, export to TIFF/BMP files and laser printing.

C. INTENDED USE

The RadWorks™ Medical Imaging Software is a medical device, and it has the same indications for use and target population as the legally marketed predicate devices.

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TECHNOLOGICAL CHARACTERISTICS D.

Both the RadWorks™ Medical Imaging Software and the ICON Teleradiology System are stand-alone software packages which can be used on more than one hardware platform. As long as minimum hardware requirements are met, the user is free to choose his/her own hardware platform.

All three systems can transmit to remote viewing stations over phone lines or networks. The All (Mode Tyclering operates on a compatible PC in a receive only mode - it does not transmit. Two regular RadWorks™ systems can send and receive images to each other.

All three systems allow digital image processing and measurement capability. All three allow optional digitization of film images.

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TESTING E.

The RadWorks™ Medical Imaging Software is tested according to the specifications that are documented
ed the success of the Taction, in an integral part, of Applicare's softw The RadWorks™ Medical Imaging Software is tested according to the Specifications national of the Research and the formers as
in a Software Safeware In a Software Test Plant Quality Handbook.

CONCLUSIONS ப்

The RadWorks™ Medical Imaging Software is a medical device, and it has the same indications for a
reas and the same the largily devices The RadWorks™ Medical Imaging Soltware is a most
use and target population as the legally marketed predicate devices

as and of predicate devices.

prediction of the characteristics of the RadWorks™ Medical Imaging Software
This procession in a whotential orgivalence This prematicel notification assure substantial equivalence.
in sufficient detail to assure substantial equivalence.

000038

Regulation Number and Section

§ 892.2020 Medical image communications device.

(a)
Identification. A medical image communications device provides electronic transfer of medical image data between medical devices. It may include a physical communications medium, modems, and interfaces. It may provide simple image review software functionality for medical image processing and manipulation, such as grayscale window and level, zoom and pan, user delineated geometric measurements, compression, or user added image annotations. The device does not perform advanced image processing or complex quantitative functions. This does not include electronic transfer of medical image software functions.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 892.9.