IMNET DICOM NETWORK AGENT by IMNET SYSTEMS, INC.

The IMNET DICOM Network Agent is a software device intended for use within the medical imaging environment. The product is a communication tool which facilitates the transfer of medical images from one system to another. Receiving medical images from a DICOM source and transmitting them to another DICOM compatible target, the product is a communication gateway for the DICOM environment.

Device Description

AI/ML Overview

I am sorry, but based on the provided text, there is no information available regarding acceptance criteria or a study proving the device meets said criteria.

The document is a 510(k) clearance letter from the FDA for the "Imnet Dicom Network Agent." It confirms that the device is substantially equivalent to legally marketed predicate devices. The second document, "EXHIBIT G: USE FORM," describes the "Indications for Use" for the device, stating it's a software device intended for transferring medical images between DICOM-compatible systems.

This type of regulatory document typically focuses on substantial equivalence to a predicate device rather than detailed performance studies and acceptance criteria as would be found in a clinical trial report or a comprehensive technical specification.

Therefore, I cannot provide the requested information, including:

A table of acceptance criteria and the reported device performance: This information is not present.
Sample size used for the test set and the data provenance: Not mentioned.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not mentioned.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not mentioned. The device is described as a "communication tool" and "communication gateway," not an AI-powered diagnostic or assistive tool for human readers.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not mentioned.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not mentioned.
The sample size for the training set: Not mentioned.
How the ground truth for the training set was established: Not mentioned.

Summary

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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name arranged in a circular pattern around a symbol. The symbol consists of a stylized caduceus-like design with three wavy lines converging at the bottom.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 3 1997

K972366

William Bain Associate General Counsel Imnet Systems, Inc. 3015 Winward Plaza Winward Fairway II Alphearetta, GA 30202

Re:

Imnet Dicom Network Agent Dated: June 24, 1997 Received: June 25, 1997 Regulatory class: Unclassified Procode: 90 LMD

Dear Mr. Bain:

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 intenstated in the enclosure) 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, subject to the general controls provisions of the Act. 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 submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control grovisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) 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,

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

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EXHIBIT G : USE FORM

Page 1 of 1

510(k) Number (if known): Not assigned yet

Device Name: IMNET® DICOM Network Agent

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

1 Prescription Use

OR Over-The-Counter Use

(Per 21 CFR 801.109

(Optional Format 1-2-96)

Thind G. Seymann

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 172366 510(k) Number

IMNET Systems CONFIDENTIAL

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.