Pegasys InTouch™ software is intended to transfer and provide interpretive displays of Pegasys and DICOM image data either compressed or uncompressed to physician workstations via a local area network (LAN) interconnected with Ethernet or via a wide area network (WAN) comprised of two or more LANs in different locations, using a hospital intranet, not the Internet.

Device Description

Pegasys InTouch™ has been developed to provide a physician with the ability to review Pegasys and DICOM images from locations outside the original study area. Pegasys InTouch™ has been designed to operate on standard, off-the-shelf hardware and software components. Using standard WinTel PC systems and the hospital proprietary LAN/WAN (either local or wide area), physicians will have the ability to review and interact with patient data from their desks.

Pegasys and other digital imaging communications systems consist of a computer with a high speed data modem connected to a standard telephone line or computer network that can transmit or receive digitized images. The system is programmed to send, receive, store, copy and display these images in a manner that assures that images are not altered. Operator interface features are also computer controlled so as to enhance the system's capabilities and make the system more user friendly. Images can be displayed with different resolutions and colors; the same image set can be viewed simultaneously at different locations on designated physician workstations.

The physician has the capability to select a variety of display formats for viewing. For example, the physician may select up to 9 separate datasets to be displayed simultaneously, including whole body and snapshot displays; comparative (tomographic) displays of oblique or transverse files; comparative cardiac SPECT data; and SPECT and gated SPECT data in a 10 frame-per-second cine mode.

AI/ML Overview

Here's an analysis of the provided information, focusing on the acceptance criteria and the study details:

This 510(k) summary for Pegasys InTouch™ provides limited detail about specific performance acceptance criteria and a formal study to prove those criteria. It seems to focus more on describing the device's functionality and its substantial equivalence to predicate devices rather than rigorous performance testing.

Acceptance Criteria and Reported Device Performance

Given the nature of the provided document, explicit performance metrics with numerical targets are not stated. The document indicates that the device's main function is to "transfer and provide interpretive displays of Pegasys and DICOM image data." The "Testing" section describes a basic functional test rather than a performance study against specific criteria.

Acceptance Criteria Category	Specific Criteria (Inferred from document)	Reported Device Performance
Image Transfer	Ability to transfer DICOM-format images.	DICOM-format image downloaded using standard web-based data transfer.
Image Display	Ability to display transferred images.	Image displayed in the image viewer, and across four display regions.
Functional Equivalence	Operates similarly to predicate PACS.	Similar to a wide variety of Picture Archive and Communication Systems (PACS) on the market.

Study Information

The "II. Testing" section describes a very basic test. It does not constitute a formal study with statistical power, expert readers, or ground truth establishment in the way current clinical performance studies for AI/CAD devices are conducted.

Sample size used for the test set and the data provenance:
- Sample Size: A single image (An image was generated).
- Data Provenance: Not specified, but the image was "generated using a prototype of the display applications," suggesting it was synthetic or specially prepared, rather than from real patient data. It is neither retrospective nor prospective in the typical sense of clinical data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not applicable. No ground truth was established by experts for this basic functional test. The test was just to see if an image could be transferred and displayed.
- Qualifications of Experts: Not applicable.
Adjudication method for the test set:
- Adjudication Method: Not applicable. There was no complex assessment requiring adjudication.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- MRMC Study: No, an MRMC comparative effectiveness study was not done. The "testing" described is a single-image, single-user functional check, not a clinical effectiveness study.
- Effect size of how much human readers improve with AI vs without AI assistance: Not applicable, as no MRMC study was conducted.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Standalone Study: Yes, in a very rudimentary sense. The "testing" described is an algorithm-only functional check (displaying an image). However, it's not a performance study in terms of accuracy or clinical effectiveness, but rather a verification of basic functionality.
The type of ground truth used:
- Type of Ground Truth: Not applicable. The test involved generating a specific image and verifying its display, not evaluating diagnostic accuracy against a ground truth.
The sample size for the training set:
- Sample Size: Not applicable. This device is a PACS system for image transfer and display, not an AI or CAD algorithm that requires a training set. There is no indication of machine learning or AI models being trained here.
How the ground truth for the training set was established:
- Ground Truth Establishment: Not applicable, as there was no training set.

Summary of Limitations:

This document describes a device from 1998, a time when regulatory expectations for software-as-a-medical-device, particularly those involving AI or complex performance claims, were vastly different from today's standards. The "testing" section is a basic functional verification rather than a clinical performance study. The focus of the 510(k) in this era for such devices was largely on establishing substantial equivalence to legally marketed predicate devices based on technological characteristics and intended use, rather than extensive clinical performance data against specific acceptance criteria.

Summary

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K974474

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS DATA

I. General Information
FEB 2 4 1998

A. Submitted By:	ADAC Laboratories
	540 Alder Drive
	Milpitas, CA 95035
	Tel: (408) 321-9100
	Fax: (408) 321-9686
Contact Person:	Dennis Henkelman at address above
B. Device Trade Name:	Pegasys InTouch™
Common Name:	Picture Archive and Communication System
	(PACS)
Classification Name:	Digital Image Communication System
C. Predicate Device:	AVP PACSPRO 640
	HyperPACS
	AMICAS Web/Intranet Image Server

D. Device Description:

Pegasys InTouch™ has been developed to provide a physician with the ability to review Pegasys and DICOM images from locations outside the original study Pegasys InTouch™ has been designed to operate on standard, off-thearea. shelf hardware and software components. Using standard WinTel PC systems and the hospital proprietary LAN/WAN (either local or wide area), physicians will have the ability to review and interact with patient data from their desks.

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1. The physician may select from a number of display formats incorporating from 1 to 9 zones as described previously.
A Tomographic Display is used to display multiple orientations of the 2. same image set in a comparative manner.
The Cardiac Stress/Rest Comparative application facilitates the visual 3. comparison of the same cardiac locations during rest and during stress.
Cardiac Comparatives is similar to the Stress/Rest application above, but 4. displays the stress and rest projections in cine motion.
E. Indications for Use:

F. Technological Comparison:
Pegasys InTouch™ is similar to a wide variety of Picture Archive and Communication Systems (PACS) currently on the market. These systems are designed to send, receive, store, copy and display high resolution digitized images. The images can be digitally scanned into the system or captured from various imaging modalities such as CT and MRI. Each system consists of either a single unit or multiple units networked. Image data is sent from a sending unit through digital network lines or through standard telephone lines by a high speed modem to a receiving station. Once the image is received, it can be stored, copied and displayed. Displayed images may be adjusted for user preference to assist in interpretation.

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Pegasys InTouch™ and other currently marketed systems consist of a PC compatible computer with a microprocessor with RAM, monitor, keyboard, mouse/trackball, internal hard drive, modem or Ethernet connection, and Microsoft Internet Explorer 3.0 or Netscape Navigator 3.0.

II. Testing

An image was generated using a prototype of the display applications. The DICOM-format image was downloaded using standard web-based data transfer and displayed into the image viewer. The same image was displayed in each of the four display regions.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

? 4 1996

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

K974474 Re:

Pegasys InTouch™ (PACS) Dated: November 25, 1997 Received: November 26, 1997 Regulatory class: Unclassified Procode: 90 LLZ

Dear Mr. Henkelman:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we bare determined the device is substantially equivalent (for the indications for use states in the exclosure) to devices marketed in interstate commerce prior to May 28, 1976, the ennotment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Comments Act (Act). You may, therefore, narket 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, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either chass III (Premarket Appoval), it may be subject to such additional controls. Existing major regulations affecting your device can be formal in the Code of Feleval Resultivions, Title 21, Parts 800 to 895, A substantially ecuivaliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (S inspections, the Food and Drug Administration (FDA) will verify auch 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(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predication 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 vitte 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/dsma/dsmamain.html".

Sincerely yours,

William Li, Ph.D.

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):

Pegasys InTouch™ Device Name:

Sponsor Name: ADAC Laboratories

Indications for Use

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use િ Over-The-Counter Use ()

David A. Syam

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devic

510(k) Number K974174

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).