The VisiShare Imaging System and/or Software is a digital imaging viewing system that receives digital images and patient demographic information from various imaging sources. The incoming data formats are standard medical image formats, proprietary image formats, and common non-medical image formats. The VisiShare allows the operator to manage, view, retrieve and store images, modify image parameters and annotate image for the purposes of radiological interpretation.

Device Description

The VisiShare Imaging System is designed to accept images from various modalities or digital image networks and allow the operator to view, retrieve, store and manipulate medical images in a variety of formats.

The VisiShare is a modular system that uses network and proprietary interfaces for communication between the modules. Network interfaces enable the various modules to reside on local or remote machines. System is designed for low-end and high-end systems, supporting single or multiple monitor configurations.

AI/ML Overview

The provided text (K974130) is a 510(k) summary for the VisiShare Imaging System and/or Software. This document focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a performance study with specific acceptance criteria and detailed study results.

Therefore, many of the requested details regarding acceptance criteria, study design, sample sizes, expert qualifications, and ground truth establishment are not provided in this regulatory submission.

Here's a breakdown of the information that can be extracted or inferred, and what is missing:

Description of Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

The provided 510(k) summary for the VisiShare Imaging System and/or Software does not detail specific acceptance criteria or a dedicated study designed to prove the device meets these criteria in the way one might expect for a diagnostic or AI-powered device. Instead, the submission focuses on demonstrating substantial equivalence to predicate devices. This means the primary "acceptance criterion" from a regulatory perspective is that the new device is as safe and effective as existing legally marketed devices, and any differences do not raise new questions of safety or effectiveness.

The document implicitly "proves" this equivalence through a comparison of design, composition, function, intended use, safety, and efficacy with the predicate devices. The listed predicate devices are:

Magic View 50 Teleradiology System [Siemens]
RadWorks Medical Imaging Software [Applicare Medical Imaging, B.V.]
AutoRad [Cemax-Icon]

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Inferred from Substantial Equivalence)	Reported Device Performance (from 510(k) Summary)
Functional Equivalence:
- Ability to view, retrieve, store, and manipulate medical images.	- "designed to accept images... allow the operator to view, retrieve, store and manipulate medical images in a variety of formats."
- Ability to modify image parameters and annotate images.	- "allows the operator to manage, view, retrieve and store images, modify image parameters and annotate image for the purposes of radiological interpretation."
- Compatibility with various imaging modalities/networks.	- "designed to accept images from various modalities or digital image networks."
- Support for standard medical image formats, proprietary, and common non-medical formats.	- "incoming data formats are standard medical image formats, proprietary image formats, and common nonmedical image formats."
System Performance Characteristics:
- Designed for off-the-shelf, general purpose computing equipment.	- "designed to run on off-the-shelf, general purpose computing equipment."
- Maximum portability across operating systems and hardware platforms.	- "application software is designed for maximum portability across operating systems and hardware platforms."
- Performance primarily a function of network load, then hardware, then display controller.	- "Performance of the application software is primarily a function of network load; secondarily a function of the hardware platform's computational speed and finally the performance of the display controller."
Safety and Efficacy:
- No significant influence on safety or efficacy compared to predicate devices.	- "Any differences between the VisiShare Imaging System and/or Software and the predicate devices have no significant influence on safety or efficacy."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not provided. The 510(k) summary does not mention a specific "test set" of medical images or patient data used for a performance study. Its focus is on substantial equivalence based on design and intended use, not on a clinical performance evaluation using a dataset.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable/Not provided. Since no specific "test set" for performance evaluation is described, there's no mention of experts or ground truth establishment in this context.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable/Not provided. No explicit test set or adjudication method is described.

5. 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 applicable. This device is an imaging viewing system, not an AI-powered diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this submission and was not performed.

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

Not applicable. This device is an interactive viewing system with a human operator in the loop for radiological interpretation. It does not perform autonomous algorithmic diagnoses.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable/Not provided. As there is no specified performance study with a test set, the concept of ground truth is not elaborated upon in this document. The "ground truth" for showing substantial equivalence relies on the known safety and effectiveness of the legally marketed predicate devices.

8. The sample size for the training set

Not applicable/Not provided. As this is not an AI/machine learning device that requires training data, there is no mention of a training set.

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

Not applicable/Not provided. Corresponding to point 8, this information is not relevant or provided.

Summary

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K974130

1. 510(k) Summary

510(k) Summary

[As required by 21 CFR 807.92(c)]

Submitter Information 1.0

1.1 DeJarnette Research Systems401 Washington Avenue Suite 700Towson MD 21204	1.2 Contact:	Eric John Finegan
	Voice:	+1 (410) 583 - 0680
	Fax:	+1 (410) 583 - 0696
	E-mail:	info@dejarnette.com

30 October 1997 1.3 Date Prepared:

Device Identification 2.0

VisiShare Imaging System and/or Software 2.1 Trade Name:
Digital Imaging Communication System 2.2 Common Name:
System, Digital Image Communication Classification Name: 2.3

Predicate Devices 3.0

Magic View 50 Teleradiology System [Siemens]

RadWorks Medical Imaging Software [Applicare Medical Imaging, B.V.]

AutoRad [Cemax-Icon]

4.0 Device Description

4.1 Function:
The VisiShare Imaging System is designed to accept images from various modalities or digital image networks and allow the operator to view, retrieve, store and manipulate medical images in a variety of formats.

Physical and Performance Characteristics: 4.2

The VisiShare Imaging System and/or Software is designed to run on off-the-shelf, general purpose computing equipment. The application software is designed for maximum portability across operating systems and hardware platforms. Performance of the application software is primarily a function of network load; secondarily a function of the hardware platform's computational speed and finally the performance of the display controller. Intrinsic performance of the application does not change significantly as it is ported from one operating system to another.

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EJARNETTE

Intended Use: 5.0

The VisiShare Imaging System and/or Software is a digital imaging viewing system that receives digital images and patient demographic information from various imaging sources. The incoming data formats are standard medical image formats, proprietary image formats, and common nonmedical image formats. The VisiShare allows the operator to manage, view, retrieve and store images, modify image parameters and annotate image for the purposes of radiological interpretation.

6.0 Statement of Substantial Equivalence:

The VisiShare Imaging System and/or Software is substantially equivalent to the previously marketed devices (as listed above in Part 3) in design, composition, function, intended use, safety and efficacy.

Any differences between the VisiShare Imaging System and/or Software and the predicate devices have no significant influence on safety or efficacy.

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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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines representing the wings and a stylized body.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AN 2 9 1998

Eric John Finegan Regulatory Manager DeJarnette Research Systems, Inc. 401 Washington Avenue, Suite 700 Towson, Maryland 21204

Re:

K974130 Visishare Imaging System and/or Software Dated: October 31, 1997 Received: November 3, 1997 Regulatory class: Unclassified Procode: 90 LMD

Dear Mr. Finegan:

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 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 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. 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 provisions, 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 question 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,

h.Jliau Yu
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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2. Statement of Indications for Use

Device: VisiShare Imaging System and/or Software

Statement of Indications for Use

[As required by 21 CFR 801.109]

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. DeYoung

Prescription Use
(Per 21 CFR 801.109) ✓

Over-The-Counter Use

401 Washington Avenue, Suite 700 Towson, Maryland 21204 Tel.: +1(410)583-0680 Fax: +1(410)583-0696

Page

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.