The RadWorks Medical Imaging Software, from Applicare Medical Imaging, B.V., when installed on an appropriate hardware platform, is intended to provide capability for the acceptance, display, storage, and digital processing of medical images. Options allow for additional capability, including transmission of images over local area networks or public communications channels, digitization of film images, acceptance of digital images directly from different medical image modalities, and quality control review and revision of studies.

Device Description

The RadWorks Quality Control Module is intended to be used by authorized staff to perform various quality control operations on RadWorks imaging studies before they are made available to other locations on the network. These operations include confirming or editing patient characteristics, reviewing the status history of the study, adding or removing images, combining with another study, renumbering images, editing patient orientation information, and setting or editing routing information.

AI/ML Overview

The provided text does not contain information about specific acceptance criteria or an explicit study proving that the device meets those criteria. The submission is focused on demonstrating substantial equivalence to a predicate device, as confirmed by the FDA's letter (K982862).

Here's an analysis based on the information provided, highlighting what is present and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Not explicitly provided. The document describes the "RadWorks Medical Imaging Software with Quality Control Module" as having various quality control operations (confirming/editing patient characteristics, reviewing status history, adding/removing images, combining studies, renumbering images, editing orientation, setting/editing routing information). However, it does not state specific performance metrics (e.g., accuracy, speed, user-friendliness) for these operations, nor does it define acceptance criteria for such metrics.

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

Not explicitly provided. The document mentions "Software testing of the new module followed Applicare's normal procedures" and that "a software test plan is developed, containing a detailed description of relevant test procedures." However, it does not specify the details of the test set, including its sample size or data provenance (e.g., country of origin, retrospective/prospective nature).

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

Not applicable/Not explicitly provided. Since no specific performance claims or a detailed test set are described for the Quality Control Module's operations, there's no mention of experts being used to establish a "ground truth" for the test set. The module's functions are primarily for data manipulation and quality control, not diagnostic interpretation requiring expert consensus on complex medical conditions.

4. Adjudication Method for the Test Set

Not applicable/Not explicitly provided. As no expert review or diagnostic assessment is detailed, an adjudication method is not mentioned.

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

No. A MRMC study typically compares human readers' diagnostic performance with and without AI assistance. The RadWorks Medical Imaging Software with Quality Control Module is described as a tool for managing and manipulating medical images, not for diagnostic interpretation. Therefore, an MRMC study is not relevant to its stated function and was not conducted or reported.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not explicitly provided within the context of performance metrics. The software performs operations for authorized staff, implying a human-in-the-loop interaction rather than a fully autonomous diagnostic or analytical algorithm. The testing described focuses on software functionality, not algorithmic performance in a standalone capacity.

7. The Type of Ground Truth Used

Not explicitly provided. Given the nature of the software (image management and quality control), "ground truth" would likely relate to the correct execution of software functions (e.g., if an image was successfully moved, if patient characteristics were correctly edited, if routing information was accurately set). This would be verified through functional testing rather than clinical ground truth like pathology or outcomes data.

8. The Sample Size for the Training Set

Not applicable. The RadWorks Quality Control Module is described as software for performing various operations on imaging studies. It is not an AI/ML algorithm that learns from a "training set" in the conventional sense (i.e., a dataset used to train a predictive model). Its functions are programmed, not learned.

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

Not applicable. As it's not a machine learning model, there is no "training set" or ground truth establishment for such a set.

Summary of what is present:

The 510(k) submission is for a modification to an existing device (K962699).
The modified device (RadWorks Medical Imaging Software with Quality Control Module) adds specific quality control operations (confirming/editing patient characteristics, reviewing status history, adding/removing images, combining studies, renumbering images, editing orientation, setting/editing routing information).
The submission asserts that the technological characteristics of the modified device are "identical" to the original.
Software testing followed Applicare's internal procedures, including a test plan describing what to test, expected results, when, by whom, resources used, and how results are recorded.
The conclusion is that the intended use is the same as the predicate, and technological characteristics are sufficient to demonstrate substantial equivalence.

In essence, this 510(k) submission primarily relies on demonstrating substantial equivalence to a predicate device and adherence to internal software testing procedures, rather than presenting a performance study with specific acceptance criteria, ground truth, or statistical analysis of algorithmic performance.

Summary

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K982862

510(k) Summarv

RADWORKS MEDICAL IMAGING SOFTWARE WITH QUALITY CONTROL MODULE

Common/Classification Name: Digital Image Communications System

Applicare Medical Imaging, B.V. P. O. Box 936 3700AX Zeist The Netherlands +31-30-6926000 FAX +31-30-6926010

Contact: Bernie van Welt Prepared: July 6, 1998

LEGALLY MARKETED PREDICATE DEVICES A.

The RadWorks Medical Imaging Software with Quality Control Module is substantially equivalent to the original version of the RadWorks Medical Imaging Software (K962699).

DEVICE DESCRIPTION B.

C. INTENDED USE

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D. TECHNOLOGICAL CHARACTERISTICS

The technological characteristics of the modified device are identical to those of the original device.

E. TESTING

Software testing of the new module followed Applicare's normal procedures. During the design phase, a software test plan is developed, containing a detailed description of relevant test procedures. Each test procedure is documented and contains a description of what to test, what the expected results are, when to test, by whom the tests will be performed, which resources (such as automated test tools) will be used and how the test results are recorded.

F. CONCLUSIONS

In summary, Applicare has demonstrated that the intended use for RadWorks Medical Imaging Software with Quality Control Module is the same as that of the original (predicate) device, and the technological characteristics have been described in sufficient detail to demonstrate that they are the same as those of the predicate device. Therefore, this premarket notification has demonstrated Substantial Equivalence as defined and understood in the Food, Drug, & Cosmetic Act and its amendments.

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Image /page/2/Picture/0 description: The image is a logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The caduceus is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 21 1998

Applicare Medical Imaging, B.V. c/o T. Whit Athey, Ph.D. C.L. McIntosh & Associates 12300 Twinbrook Parkway, Suite 625 Rockville, MD 20852

K982862

Re:

RadWorks Medical Imaging Software with Quality Control Module Dated: August 13, 1998 Received: August 13, 1998 Regulatory class: II 21 CFR 892.2050/Procode: 90 LLZ

Dear Dr. Athey:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the exclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments or to devices that have been reclassified in accordance with the provisions of the Federal Food . Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice Jabeling; and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Modisol Devices» General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(1) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market: "

If you desire specific advice for your device on our labeling regulation (21 CFR Part 80V-and additionally 809.10 for in ritin diagnostic devices), please contact the Office of Compliance at (301) 594-4643. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/odrf/dsma/dsmamain.html".

Sincerely yours,

William Yip, Ph.D.

Lillian Yin, Ph.D. Director, Division of Reproductive Abdominal, Ear, Nose and Throa and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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STATEMENT OF INDICATIONS FOR USE

510(k) Number (if known): K (332862

Device Name: RadWorks Medical Imaging Software with Quality Control Module

Indications For Use:

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

510(k) Number

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel C. Bergman

(Division Sign-Off)

Division of Reproductive, Abdominal, ENT,
and Radiological Devices

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use

Regulation Number and Section

§ 892.2050 Medical image management and processing system.

(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).