The Sectra IDS device is intended for the manipulation and displaying of x-ray images. It can show images from different modalities and interfaces to various image storage and printing devices using DICOM or similar interface standards.

Device options make possible telecommunications; fast demonstration; prosthesis CAD; 3-D and angiography, etc .; and teleconferencing.

Typical users of this system are trained professionals, including but not limited to physicians, radiologists, nurses, medical technicians, and assistants.

Device Description

The IDS5 10.1 Radiology Workstation is mainly a software product. It is used for visualization and processing of digital radiology images. The system runs under the Window 2000 and Windows XP operating system. The requirements on hardware are quite ordinary for a system used for displaying images. Most notably up to four monitors can be used.

AI/ML Overview

This document describes a 510(k) submission for the Sectra IDS5 Radiology Workstation - Version 10.1, a Picture Archiving and Communications System (PACS).

Here's an analysis of the acceptance criteria and study information provided in the input, specifically focusing on what is present and absent from the document:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
ISO 9001:2000 Compliance	Developed according to ISO 9001:2000
ACR/NEMA Digital Imaging Communications in Medicine (DICOM) version 3.0 Compliance	Complies with ACR/NEMA Digital Imaging Communications in Medicine version 3.0
Substantial Equivalence to Predicate Device (Sectra IDS5 Radiology Workstation - Version 7, K002936)	Concluded to be safe, effective, and substantially equivalent to the predicate device based on shared certification/conformance to standards and functional similarity as an Image Processing System (LLZ).
Ability to manipulate and display x-ray images from different modalities, interface with image storage and printing using DICOM/similar standards.	The device is intended for this purpose and its functions support it.
Supports telecommunications, fast demonstration, prosthesis CAD, 3-D, angiography, and teleconferencing through device options.	The device options make these functions possible.
Operates on Windows 2000 and Windows XP operating systems.	The system runs under these operating systems.
Protection against unauthorized use (passwords).	Passwords are required for operation.
Image/data recovery mechanisms in case of transmission failure.	Device failures may be recovered from storage or retransmission.

2. Sample size used for the test set and the data provenance

Absent. The document does not describe a clinical study or a test set of images with a defined sample size. The performance data section refers to compliance with standards rather than a specific study involving image data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Absent. Since there is no described clinical study or test set for evaluation of image interpretation performance, there is no mention of experts establishing ground truth for such a set. The document states that images and information are "interpreted by a physician or trained medical personnel," implying human oversight during clinical use, but not in the context of device validation.

4. Adjudication method for the test set

Absent. No test set or corresponding adjudication method is described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance

Absent. The device described is a PACS workstation, an image processing and display system. It does not appear to incorporate AI or CAD (Computer-Aided Detection/Diagnosis) directly for interpretation assistance. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable and not mentioned.

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

Absent. As noted above, this device is a workstation for displaying and manipulating images, not a standalone AI algorithm for diagnostic interpretation. Its performance is related to its ability to correctly process and present images according to standards, leaving interpretation to human users.

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

Absent. This information is not relevant in the context of the provided performance data, which focuses on compliance with technical standards (ISO, DICOM) and substantial equivalence to a predicate device for its intended function as an image display and processing system. The core function is presenting images, not independently deriving diagnostic conclusions that would require a ground truth comparison.

8. The sample size for the training set

Absent. This device is a software product for viewing and manipulating images; it does not explicitly use a "training set" in the context of machine learning for diagnostic tasks. Its development followed ISO 9001:2000, which is a quality management system standard.

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

Absent. As there is no described training set for a machine learning model, the establishment of ground truth for such a set is not applicable.

Summary

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

K033088E

OCT 2 9 2003

Sectra Document Number: 3-03.1632-1.0

510(k) Summary of Safety & Effectiveness

(as required by 21 CFR 807.92c)

Date Prepared:

September 23, 2003

Submitter's Information:

Sectra Imtec AB Teknikringen 20 SE-583 30 Linköping Sweden Phone: +1 46 13 23 52 00 Fax: +1 46 13 21 21 85

Trade Name, Common Name, Classification:

Trade Name:	Sectra IDS5 Radiology Workstation - Version 10.1
Common Name:	Picture Archiving and Communications System
Classification Name:	Image Processing System (LLZ) (21 CFR § 892.2050)

Predicate Device:

Applicant:	Sectra Imtec AB
510(k) Number:	K002936
Device:	Sectra IDS5 Radiology Workstation - Version 7.

Device Description:

Indications for Use:

Device options make possible telecommunications; fast demonstration; prosthesis CAD; 3-D and angiography, etc .; and teleconferencing.

Typical users of this system are trained professionals, including but not limited to physicians, radiologists, nurses, medical technicians, and assistants.

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

Technological Characteristics:

The IDS5 10.1 system will run on Windows 2000 and Windows XP operating system for PCs. (as a minimum and depending upon system configuration).

Performance Data:

The subject device is developed according to ISO 9001:2000 and complies with ACR/NEMA Digital Imaging Communications in Medicine version 3.0.

Conclusion:

Similar to the predicate device, the IDS5 10.1 does not contact the patient, nor does it control any life sustaining devices. Images and information being reviewed, processed, relayed, and or transmitted are interpreted by a physician or trained medical personnel, providing ample opportunity for competent human intervention. The device and the predicate device share the same certification or conformance to performance standards and both function as Image Processing System (LLZ). Device failures, which might result in partial or failed transmissions, images, or data, may be recovered from storage or retransmission after correcting the problem(s). Passwords are required for operation and to protect against unauthorized use.

Based on the information supplied in this 510(k), we conclude that the subject device is safe, effective, and substantially equivalent to the predicate device.

Pt. Avel

Peter Andersson Regulatory Affairs Officer Sectra Imtec AB Linköping, Sweden

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

Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The symbol is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter of the circle. The text is written in all capital letters.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Sectra Imtec AB % Mr. Carl Alletto United States Agent OTech, Inc. 1100 Lakeview Blvd. DENTON TX 76208

OCT 2 9 2003

Re: K033088 Trade/Device Name: SECTRA IDS5 Radiology Workstation Version 10.1 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communication system Regulatory Class: II Product Code: 90 LLZ Dated: September 25, 2003 Received: September 29, 2003

Dear Mr. Alletto:

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.

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.

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

Page 2

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:

8xx. 1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

510(k) Number: Kó3 3088

Device Name: IDS (Image Display System) by Sectra Imtec AB

Indications For Use:

Device options make possible telecommunications; fast demonstration; prosthesis CAD; 3-D and angiography, etc .; and teleconferencing.

Typical users of this system are trained professionals, including but not limited to physicians, radiologists, nurses, medical technicians, and assistants.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over -The-Counter Use ________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

David A. Ingram

(Division Sign-Off Division of Reproductive and Radiological Devic 510(k) Number

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).