The ImageSVR PACS is intended for the manipulation, management, and display of medical images. It can manage and display images from different modalities and interfaces and can distribute those images to various workstation, image storage and printing devices using DICOM or similar standards. Typical users of this system are trained medical professionals, including physicians, nurses, technicians and computer system professionals.

To support the diagnostic interpretation of mammography studies, ImageSVR PACS will display the full fidelity DICOM image in a non-compressed format. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5Mpixel resolution and meets other technical specifications reviewed and accepted by FDA. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary diagnosis or image interpretation.

Device Description

The ImageSVR PACS is a suite of applications designed and produced by Jaguar Technology Ltd. It is a client-server based software system manages archiving, retrieving and displaying medical images. The server side application is ImageSVR PACS SERVER. And client side is ImageSVR PACS CLIENT.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Jaguar Technology Limited ImageSVR PACS, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state specific quantitative acceptance criteria or detailed performance metrics for the ImageSVR PACS. Instead, it focuses on general characteristics and its substantial equivalence to a predicate device.

Acceptance Criteria (Implied)	Reported Device Performance
Management and display of medical images across modalities	The ImageSVR™ PACS is a client-server based software system that manages archiving, retrieving, and displaying medical images. It manages and displays images from different modalities and interfaces and distributes them to various workstations, image storage, and printing devices using DICOM or similar standards.
Support for diagnostic interpretation of mammography studies	Displays full fidelity DICOM images in a non-compressed format for mammography. Acknowledges that mammographic images must be interpreted using an FDA-approved monitor with at least 5Mpixel resolution and other specified technical specifications. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary diagnosis or image interpretation.
Software Validation (Safety and Effectiveness)	The submission contains results of software validation where risks and potential hazards have been classified as "Minor."
Substantial Equivalence to Predicate Device (Taiwan Electronics Data Processing Corporation Smart PACS (K022710))	Claimed based on having the same working principle and technologies. Differences are due to feature design aspects, not relating to safety or effectiveness. The software validation results further support this claim.
Not controlling life-sustaining devices or directly contacting patients	"The ImageSVR PACS is a software server application and does not contact the patient, nor does it control any life sustaining devices."
Allowing for competent human intervention	"A physician, providing ample opportunity for competent human intervention interprets images and information being displayed and printed."

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

The document does not specify a sample size for a test set, nor does it mention any specific test set data provenance (country of origin, retrospective/prospective). The evaluation appears to be based on software validation and a comparison to a predicate device rather than a clinical performance study with a patient dataset.

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

This information is not provided in the document. As there's no mention of a clinical test set requiring ground truth, the number or qualifications of experts are not relevant to the presented information.

4. Adjudication Method for the Test Set

This information is not provided in the document. Similar to point 3, without a defined test set requiring ground truth, an adjudication method is not discussed.

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

There is no mention of an MRMC comparative effectiveness study being conducted. The device (ImageSVR PACS) is a general PACS system for image management and display, not an AI-assisted diagnostic tool. Therefore, an effect size of human readers improving with/without AI assistance is not applicable here.

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

This information is not provided. The ImageSVR PACS is described as a system for image manipulation, management, and display, with a physician interpreting the images. There is no indication of a standalone algorithm performance evaluation in a diagnostic context.

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

The document does not describe the use of any specific ground truth type in the context of a clinical performance study. The evaluation focuses on software validation and substantial equivalence.

8. The Sample Size for the Training Set

There is no mention of a training set sample size. The ImageSVR PACS is a software system for image management and display, not a machine learning or AI-based diagnostic tool that would typically require a training set for model development.

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

This information is not provided as there is no mention of a training set or its associated ground truth in the context of this device.

Summary of Device Evaluation Approach:

The documentation provided for the Jaguar Technology Limited ImageSVR PACS focuses on demonstrating:

Software Validation: Confirmation that the software functions as intended and that risks and potential hazards are classified as "Minor."
Substantial Equivalence: A direct comparison to a legally marketed predicate device (Taiwan Electronics Data Processing Corporation Smart PACS, K022710) based on shared working principles and technologies, with differences attributed to feature design rather than safety or effectiveness.
General Performance Characteristics: Describing its capabilities in managing, archiving, retrieving, and displaying medical images across various modalities, especially noting its handling of mammography images in full fidelity.

This type of submission is typical for PACS systems that primarily facilitate the viewing and management of medical images rather than performing automated diagnostic interpretations. Therefore, the detailed studies and ground truth methodologies associated with AI-driven diagnostic devices are not present.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for Jaguar Technology. The logo consists of the letters 'JTF' stacked on top of each other in a stylized, blocky font. Below the logo, the words 'jaguar technology' are written in a smaller, sans-serif font.

Limited Technology Jaguar

19F-7, No.378, Sec. 1, Wunsin Rd., Nantun District, Taichung City 408, Taiwan R.O.C.

tel:886-4-23195786 fax:886-4-23814466 www.jaguartech.com.tw

	2. ADMINISTRATIVE INFORMATION	K082808
	2.1 510(k) Summary of Safety and Effectiveness	JAN - 9 2009
	(Per 21 CFR 807.92)
	General Information Establishment
Manufacturer:	Jaguar Technology Limited
Address:	19F-7, No.378, Sec.1, Wusin Rd., Nantun District, Taichung City, 40862,
Taiwan, ROC
Owner Number:	10026627
Contact Person:	Dr. Jen, Ke-Min E-mail: ceirs.jen@msa.hint.net
(official correspondent)	886-3-5208829 (Tel); 886-3-5209783 (Fax)
Address:	No.58, Fu Chiun Street, Hsin Chu City, 30067, Taiwan, ROC
Date Prepared:	September 20, 2008
	Device Information
Proprietary Name:	ImageSVR TM PACS
Classification Name:	SYSTEM, IMAGE PROCESSING, RADIOLOGICAL,
	Class II
Regulation Number:	892.2050
Product Code:	LLZ
	Safety and Effectiveness Information

Safety and Effectiveness Information

● Predicate Device:

Claim of Substantial Equivalence (SE) is made to Taiwan Electronics Data Processing Corporation Smart PACS (K022710)

. Device Description:

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Technology Limited laquar

9F-7, No.37B, Sec. 2, Wunsin Rd., Nantun District, Taichung-City 408, Taiwan R.O.C.

tel:886-4-23195786 fax:886-4-23814466 www.jaquartech.com.tw

Intended Use: .

laguar technology

To support the diagnostic interpretation of mammography studies, ImageSVR PACS in a non-compressed the full fidelity DICOM image will display format. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5Mpixel resolution and meets other technical specifications reviewed and accepted by FDA. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary diagnosis or image interpretation.

Technological Characteristics

The ImageSVR PACS is a software server application and does not contact the patient, nor does it control any life sustaining devices. A physician, providing ample opportunity for competent human intervention interprets images and information being displayed and printed.

Substantial Equivalence (SE)

A claim of substantial equivalence is made to Smart PACS (K022710). Both of them have the same working principle and technologies. - The differences are due to the feature design aspects, not relating to the safety or effectiveness aspects. Besides, the submission contains the results of software validation that the risks and the potential hazards have been classified Minor. Thus they are substantially equivalent.

te-Din-Ten

Dr. Jen, Ke-Min official correspondent for Jaguar Technology Limited

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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or other bird. The symbol is composed of three curved lines that suggest the wings and body of the bird.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN - 9 2009

Jaguar Technology Limited % Dr. Jen. Ke-Min Official Correspondent ROC Chinese-European Industrial Research Society No. 58. Fu Chiun Street Hsin Chu City, TW-HSQ 30067 CHINA (Taiwan)

Re: K082808

Trade/Device Name: Jaguar Technology Limited ImageSVR PACS Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: November 20, 2008 Received: December 29, 2008

Dear Dr. Jen, Ke-Min:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, 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 II (Special Controls) or class III (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding os 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), please . contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.

21 CFR 876.xxx	(Gastroenterology/Renal/Urology)	(240) 276-0115
21 CFR 884.xxx	(Obstetrics/Gynecology)	(240) 276-0115
21 CFR 892.xxx	(Radiology)	(240) 276-0120
Other		(240) 276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufactures, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry.suppot/index.html.

Sincerely yours,

Janine M. Morris

anine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

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Image /page/4/Picture/0 description: The image shows the logo for Jaguar Technology. The logo consists of the letters 'JT' stacked on top of each other in a stylized font. Below the logo, the words 'jaguar technology' are written in a simple, sans-serif font. The logo is black and white.

Limited Jaguar Technology

19F-7, No.378, Sec. 1, Wunsin Rd., Nantun District, Taichung City 408, Taiwan R.O.C.

tel:886-4-23195786 fax:886-4-23814466 www.jaguartech.com.tw

- Indications for Use

K082808 510(k) Number:

(

Device Name: Jaguar Technology Limited

ImageSVR PACS

Indications for Use:

· The ImageSVR PACS is intended for the manipulation, management, and display of medical images. It can manage and display images from different modalities and interfaces and can distribute those images to various workstation, image storage and printing devices using DICOM or similar standards.
Typical users of this system are trained medical professionals, including physicians, nurses, technicians and computer system professionals.
To support the diagnostic interpretation of mammography studies, ImageSVR PACS will display the full fidelity DICOM image in a non-compressed format. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5Mpixel resolution and meets other technical specifications reviewed and accepted by FDA. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary diagnosis or image interpretation.
Prescription Use V

. AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number K082808

ﮯ

Page of

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).