The iiSYS PACS System is a complete PACS System for the Transmission, Display, Archive, and printing of patient images and demographic information. The system is indicated for the assembly, organization, sharing, and display of patient images and demographic information for diagnostic and referral purposes.

Application areas include radiologist central reading rooms or any location where a medical professional would require or desire access to patient image and demographic information.

Device Description

The iiSYS PACS System is a full featured PACS System capable of transmission, archive, display, and print of patient image and demographic information. Its purpose is to facilitate these operations utilizing shared data to promote the availability of information at remote facilities and at locations other than that at which it was acquired. Data may be received as digital information, video signals, or hard copy prints and may be reviewed via monitor or printed hardcopy. The iiSYS PACS system consists of the following major components:

Series of Viewing and Reading Workstations
Teleradiology devices for digitizing and transmission of images over wide area or local area networks for remote or at home review
Archive for short or long term storage
LINX Network system for secondary capture and transmission of images to other devices (workstation, telerad, printers, etc.)
Printers

AI/ML Overview

The provided text describes the "iiSYS PACS System," which is a Picture Archiving and Communication System. This document is a 510(k) submission, confirming that the device is substantially equivalent to existing, cleared devices.

Here's an analysis of the requested information based on the provided text:

Key Takeaway: The provided document is a 510(k) submission for a PACS system, which is essentially an integration of existing, cleared components. The "study" referenced is primarily an integration testing protocol to ensure connectivity and efficiency of these components when used together, rather than a clinical performance study measuring diagnostic accuracy. Therefore, many of the typical acceptance criteria and study details for an AI/CAD device (like sensitivity, specificity, reader performance improvements) are not applicable or not reported in this type of submission.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of the device (a PACS system integrating existing components) and the provided document (a 510(k) summary focused on substantial equivalence), the acceptance criteria are centered on connectivity, compatibility, and functional integrity rather than diagnostic performance metrics like sensitivity or specificity.

Acceptance Criteria Category	Specific Criteria	Reported Device Performance	Study that Proves Device Meets Criteria
Connectivity & Integration	Guaranteed connectivity between integrated components.	"guaranteed connectivity" provided by integration testing.	"comprehensive testing protocol" and "Integration Test Protocol"
Functional Efficiency	Efficiency of component operation when utilized together.	"efficiency" ensured by testing; "maximum value-added to the clinical environment."	"Integration Test Protocol"
Safety	No adverse impact on current technology or patient safety.	"without impacting safety or efficacy of the individual components." Device has "no patient contacting materials." "Output evaluated by additional trained professionals allowing sufficient review to afford identification and intervention in the event of a malfunction."	Review of component specifications, intended use, and implementation of integration testing.
Efficacy (Clinical)	No adverse impact on efficacy of individual components.	"without impacting safety or efficacy of the individual components." "does not impact the quality or status of the original acquired image data."	Review of component specifications and intended use. The system's efficacy is the "compiled uses of the integrated components."
Intended Use	Serves its purpose of transmission, archive, display, and printing for diagnostic/referral purposes.	"complete PACS System for the Transmission, Display, Archive, and printing of patient images and demographic information."	This is inherent in the functional description and the intended use of the integrated components.

Study Proving Device Meets Acceptance Criteria

The study described is an integration testing protocol.

Study Type: Integration Testing / Verification and Validation (V&V) of a system composed of previously cleared devices.
Purpose: To ensure the connectivity, compatibility, and efficient operation of various PACS components (workstations, teleradiology devices, archive, network system, printers) when assembled as the "iiSYS PACS System." The goal is to demonstrate that the integrated system functions as intended without negatively impacting the safety or efficacy of its individual cleared components.
Methodology: The document states that the integration is accomplished via a "comprehensive testing protocol" and an "Integration Test Protocol." While specifics of the tests are not detailed, in general, such protocols would involve end-to-end testing of image transmission, storage, retrieval, display, and printing functionalities, along with checks for data integrity and system performance under various loads. Given the 1998 date, these would have likely been manual and automated functional tests.

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

Sample Size for Test Set: Not explicitly stated as a number of patient cases or images. The "test set" for this type of system would likely involve a varied set of representative digital images and demographic data to test the system's core functionalities (transmission, archive, display, print) and interoperability standards (e.g., DICOM). The focus is on system functionality rather than diagnostic accuracy on a specific disease cohort.
Data Provenance: Not specified. Given it's a PACS system for general use, the test data would likely be synthetic, anonymized clinical data, or existing institutional data used for system testing. The country of origin and retrospective/prospective nature are not mentioned, but it would typically be retrospective internal testing data.

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

Number of Experts: Not applicable or not specified. For a PACS integration study, ground truth in the sense of diagnostic accuracy (e.g., presence/absence of disease) is not the primary focus. The "ground truth" would relate to whether the system correctly transmits, stores, retrieves, and displays images and data according to specifications. This is typically verified by engineers, IT professionals, and potentially radiologists acting as end-users validating system functionality, rather than establishing diagnostic ground truth on patient cases.
Qualifications of Experts: Not specified.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable or not specified. Adjudication (like 2+1, 3+1 for resolving diagnostic discrepancies) is used when establishing a diagnostic ground truth for patient cases. For a pure PACS integration test, the "judgement" is whether the system performs according to its functional specifications, which is typically a pass/fail outcome for each test case, often determined by a single tester or a testing team without a formal adjudication panel.

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

MRMC Study: No. An MRMC study is designed to evaluate the diagnostic performance of a device, often a CAD or AI algorithm, and its impact on human reader performance. The iiSYS PACS System is an infrastructure device, not a diagnostic aid or AI algorithm. Its purpose is to manage images, not to interpret them or improve human interpretation accuracy.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

Standalone Study: No. This question applies to AI/CAD algorithms that provide a diagnostic output. The iiSYS PACS System does not have a standalone "algorithm" for diagnostic purposes. Its standalone performance relates to its functional operability (e.g., successful image transfer rate, storage capacity, display capabilities), which would have been part of the integration testing.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

Type of Ground Truth: For this PACS system, the "ground truth" is primarily based on functional specifications and expected system behavior. This means:
- Data Integrity: Verifying that images and demographic information are transmitted, stored, and retrieved without corruption or loss.
- Display Accuracy: Ensuring images are displayed correctly with appropriate resolution and tools.
- Connectivity: Confirming that all integrated components can communicate and exchange data.
- Performance: Demonstrating that the system responds within acceptable timeframes for various operations.
- This is not "expert consensus, pathology, or outcomes data" in the diagnostic sense, but rather verification against engineering and functional requirements.

8. The Sample Size for the Training Set

Sample Size for Training Set: Not applicable. For a PACS system that integrates existing components, there isn't a "training set" in the context of machine learning. The system's "knowledge" or functionality is engineered through software development and configuration, not learned from data in the AI sense.

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

How Ground Truth for Training Set Was Established: Not applicable, as there is no "training set" for this type of device in the context of learning or AI.

Summary

{0}------------------------------------------------

K980220 Page 1 of 2

Summary of Safety and Effectiveness

CLASSIFICATION NAME:	The proposed classification is 21CFR892.2050 (FR 63774, Dec 2, 1997) This device is regulated as Class II Tier I.
COMMON/USUAL NAME:	PACS System
TRADE/PROPRIETARY NAME:	iiSYS PACS System
ESTABLISHMENT No.	1043882

PREDICATE DEVICE

FEB 1 3 1998

There are no significant differences between the System and its assembled component devices other than the guaranteed connectivity provided by the integration testing. The integration of the devices into the Sterling Diagnostic Imaging iiSYS PACS System is accomplished via comprehensive testing protocol.

There is no change in intended use from the component devices. There is no change in indications for use of the component devices. The intended use and indications for use of the system is the compiled uses of the integrated components.

REASON FOR 510(k):

The submission is being made to identify Sterling Diagnostic Imaging, Inc. as offering a complete PACS System which may become a separate device category under proposed regulations. All integral parts of the system have been previously reviewed and cleared by the Agency.

SYSTEM DESCRIPTION:

Series of Viewing and Reading Workstations ●
Teleradiology devices for digitizing and transmission of images over wide area or . local area networks for remote or at home review
Archive for short or long term storage .
LINX Network system for secondary capture and transmission of images to other . devices (workstation, telerad, printers, etc.)
. Printers

The major elements of the System are previously cleared devices as identified in the following submission. Sterling is not altering the specifications, claims, indications, or intended use of any component. The Sterling iiSYS PACS System is a compilation of components that has been professionally tested to insure their connectivity and efficiency when utilized together. This testing is optimized to give the user assurance that the devices will provide a maximum value-added to the clinical environment without impacting safety or efficacy of the individual components. Connectivity and compatibility are evaluated and ensured via the Integration Test Protocol.

{1}------------------------------------------------

INTENDED USE

Application areas include radiologist central reading rooms or any location where a medical professional would require or desire access to patient image and demographic information.

SAFETY INFORMATION:

The System has no patient contacting materials and is utilized only by trained professionals. The output of the device is evaluated by additional trained professionals allowing sufficient review to afford identification and intervention in the event of a malfunction. The device does not impact the quality or status of the original acquired image data.

Selection of the specific components of the system has been made to allow the system to remain cost effective and consistent with current technology through the substitution of components as technology develops. By retaining criteria for the substitution of components, any concerns about safety or efficacy and substantial equivalence can be satisfactorily met by a determination that the component substitution is not a significant change in this is consistent with existing Agency guidance.

CONCLUSION [21 CFR: 807.92(b)(3)]

The subject device has no patient contact, nor does it control, monitor, or effect any devices directly connected to or effecting such a patient contacting device. The images generated by the subject device is observed by medical personnel, offering ample opportunity for competent human intervention in the event of a failure.

Sterling believes sufficient information is included to reach a determination of substantial equivalence. We conclude that the subject device is as safe and effective as the component devices.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image contains the text 'Public Health Service'. The text is in a simple, sans-serif font and is horizontally aligned. The words are stacked on a single line and are easily readable.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 3 1998

Timothy W. Capehart Manager of Regulatory Affairs and Compliance Sterling Diagnostic Imaging, Inc. 10 South Academy Street Mailstop 102 P.O. Box 19048 Greenville, SC 29602-9048

Re:

K980220 iiSYS PACS System Dated: January 22, 1998 Received: January 22, 1998 Regulatory class: Unclassified Procode: 90 LMD

Dear Mr. Capehart:

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 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 marked 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 yitro 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.btml".

Sincerely yours.

William Yu, 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

{3}------------------------------------------------

510(k) Number (if known) :

K980220

Device Name :

iiSYS PACS System

Indications for Use:

The iiSYS PACS System is a complete PACS System for thhe Transmission, Display, Archive, and printing of patient images and demographic information. The system is indicated for the assembly, organization, sharing, and display of patient images and demographic information for diagnostic and referral purposes.

Application areas include radiologist central reading rooms or any location where a medical professional would require or desire access to patient image and demographic information.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Varial A. Seym

(Division Sign-Off)

(Division of Reproductive, Abdominal, E and Radiological Dev 510(k) Number

Prescription Use
(Per 21 CFR 801.109) ✓

Over the Counter Use

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.