DICOM 3.0 Software Version 2.0 is intended to provide communication and data interchange between multi-modality medical imaging devices, while maintaining the integrity of the image data.

Device Description

DICOM 3.0 Software Version 2.0 is a connectivity package software developed according to the ACR-NEMA standard for Digital Imaging and Communication in Medicine (DICOM 3.0). This software converts medical images, such as NM, CT, MRI, or Ultrasound, that are in DICOM 3.0 specified format into Pegasys image format and vice-versa to enable data communication between ADAC Pegasys systems and other medical imaging devices.

Three major operations can be performed with DICOM 3.0 Software Version 2.0 - image data transfer between ADAC systems, data output to DICOM compatible printers, and transfer of image data between ADAC and non-ADAC systems.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the DICOM 3.0 Software Version 2.0 (K973239):

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Software functions as per specifications	All tests passed with actual results matching expected results.
Image integrity maintained during import/export functions	Comprehensively tested and affirmed during testing.
Print functions fully operational	Tested and affirmed during testing.

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

The document does not explicitly state a specific sample size (e.g., number of images, patient cases) for the test set. It broadly refers to "Import and Export functions" and "Print functions" being "comprehensively tested" and "All tests passed."

Test Set Sample Size: Not specified.
Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).

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

The document does not mention the use of experts to establish a ground truth for the test set. The testing appears to be focused on the functional performance of the software against its technical specifications, rather than evaluating clinical performance that would require expert review.

4. Adjudication Method for the Test Set

No adjudication method is mentioned as there's no indication of multiple readers or subjective assessment required for the functional testing conducted.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The device is a connectivity software, not an AI-assisted diagnostic tool for which such a study would be relevant.

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

Yes, in a way. The testing described is a standalone evaluation of the software's functional performance – how well it transfers and handles image data. There's no human element being integrated into the performance evaluation itself for this type of device. The focus is purely on the algorithm's ability to execute its intended technical functions.

7. The Type of Ground Truth Used

The ground truth used for this study was the expected functional behavior and technical specifications of the DICOM 3.0 standard and the software itself. For instance, if an image was imported, the "ground truth" would be that the exported image should be an exact, integrity-maintained replica of the original, as defined by DICOM 3.0.

8. The Sample Size for the Training Set

The concept of a "training set" is not applicable to this device. This is a software application for image communication and conversion, not a machine learning or AI-driven system that requires a training set.

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

As there is no training set for this type of software, this question is not applicable.

Summary

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510(k) SUMMARY OF SAFETY AND EFFECTIVENESS DATA NOV 2 6 1997

I. General Information

K973239

A. Submitted By:	ADAC Laboratories540 Alder DriveMilpitas, CA 95035Tel: (408) 321-9100Fax: (408) 321-9686
Contact Person:	Dennis Henkelman at address above
B. Device Trade Name:	DICOM 3.0 Software Version 2.0
Common Name:	Gamma Camera System
Classification Name:	Digital Image Communication System
C. Predicate Device:	Cemax VipstationAVP PACSPRO 640

Device Description: D.

E. Indications for Use:
DICOM 3.0 Software Version 2.0 is intended to provide communication and data interchange between multi-modality medical imaging devices, while maintaining the integrity of the image data.

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Technological Comparison: F.

DICOM 3.0 Software Version 2.0 and the communication/data interchange portions of the predicate devices have the same indications for use. The operating principles of DICOM 3.0 Software Version 2.0 and the predicate devices are based on ACR-NEMA standard for Digital Imaging and Communication in Medicine (DICOM 3.0), as described in the device description. Communication media, such as, Local Area Network (LAN), Wide Area Network (WAN), and Internet are used to send or receive image data.

II. Testing

Testing was conducted to demonstrate that the software functioned as per its specifications. Import and Export functions were comprehensively tested to ensure that image integrity was maintained. The Print functions were also tested. All tests passed with the actual results matching the expected results.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three stylized lines.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Re:

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 26 1997

Dennis W. Henkelman Director, Regulatory Affairs and Quality Assurance ADAC Laboratories 540 Alder Drive Milpitas, CA 95035

K973239 DICOM 3.0 Software Version 2.0 Dated: August 22, 1997 Received: August 28, 1997 Regulatory class: Unclassified Procode: 90 LMD

Dear Mr. Henkelman:

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 enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, 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, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either 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 requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS 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 does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your 5100k) 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 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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/cdrh/dsmamain.html".

Sincerely yours

W. Lillian Yin, Ph.D.

Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K Y 1 32 3 7

DICOM 3.0 Software Version 2.0 Device Name:

ADAC Laboratories Sponsor Name:

Indications for Use

DICOM 3.0 Software Version 2.0 is intended to provide communication and data interchange between multi-modality medical imaging devices, while maintaining the integrity of the image data.

Do Not Write Below This Line - Continue on Another Page if Needed

Concurrence of CDRH, Office of Device Evaluation (ODE)

David li. de yarm

Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number

Prescription Use
Over-The-Counter Use

Regulation Number and Section

N/A