The Sectra IDS device is intended for the manipulation and displaying of x-ray images, including mammograms. 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 mammography reading, 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 Radiology Workstation with IDS5/mx.net 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

Here's a breakdown of the acceptance criteria and study information for the Sectra IDS5 Radiology Workstation, based on the provided text:

Important Note: The provided document is a 510(k) Summary and the FDA's clearance letter. It focuses on demonstrating substantial equivalence to a predicate device, not on specific performance studies with detailed acceptance criteria and results in the way a clinical trial might be presented. Therefore, many of the requested details (like sample size for test sets, ground truth methodology, expert qualifications, effect size for MRMC studies, etc.) are not present in this type of document, as they are not typically required for a 510(k) for an image processing system like this. The "Performance Data" section primarily refers to compliance with standards.

Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Safety: Device does not pose undue risk to patients or users.
Does not contact the patient.	Does not contact the patient.
Does not control life-sustaining devices.	Does not control life-sustaining devices.
Competent human intervention is always present.	Images and information are interpreted by a physician or trained medical personnel, providing ample opportunity for competent human intervention.
Protection against unauthorized use.	Passwords are required for operation and to protect against unauthorized use.
Recovery from failures (partial or failed transmissions, images, data).	Device failures may be recovered from storage or re-transmission after correcting the problem(s).
Effectiveness/Functionality: Device performs its intended functions.
Visualization and processing of digital radiology images (including mammograms).	Used for visualization and processing of digital radiology images, including mammograms.
Runs on specified operating systems (Windows 2000, XP).	Runs under Windows 2000 and Windows XP operating system.
Supports up to four monitors.	Up to four monitors can be used.
Interfaces with various image storage and printing devices using DICOM or similar standards.	Interfaces to various image storage and printing devices using DICOM or similar interface standards.
Supports optional features like mammography reading, telecommunications, fast demonstration, prosthesis CAD, 3-D and angiography, teleconferencing.	Device options make possible mammography reading, telecommunications; fast demonstration; prosthesis CAD; 3-D and angiography, etc .; and teleconferencing.
Follows ISO 9001:2000 quality management standards.	Developed according to ISO 9001:2000.
Complies with ACR/NEMA Digital Imaging Communications in Medicine version 3.0.	Complies with ACR/NEMA Digital Imaging Communications in Medicine version 3.0.
Substantially equivalent to predicate device.	Concluded to be safe, effective, and substantially equivalent to the predicate device (Sectra IDS5 Radiology Workstation - Version 10.0, K0033088).

Study Details:

Sample size used for the test set and the data provenance:
- Not specified in this 510(k) summary. For image processing systems of this nature, performance testing often involves internal verification and validation against specified technical requirements rather than a formal clinical study with a "test set" of patient data in the sense of a diagnostic performance study. The focus is on functionality and safety equivalence.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not specified. Ground truth establishment is not detailed as this is not a diagnostic AI device requiring such a process for its 510(k) clearance.
Adjudication method for the test set:
- Not specified. Adjudication is not applicable in the context of the information provided.
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:
- No MRMC study was done or reported. This device is a workstation for viewing and processing images, not an AI-assisted diagnostic tool designed to directly improve human reader performance in a quantifiable clinical output metric (like sensitivity or specificity).
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No standalone performance study of an algorithm was done or reported. This device is not an algorithm that provides a diagnostic output independently; it's a tool for human interaction with images.
The type of ground truth used:
- Not applicable/Not specified. The "ground truth" here would relate to the correct display and manipulation of images according to DICOM standards and user specifications, not a clinical diagnosis.
The sample size for the training set:
- Not applicable/Not specified. This is not a machine learning/AI device that requires a "training set" in the conventional sense for developing a diagnostic algorithm. Its development is based on software engineering principles and compliance with standards.
How the ground truth for the training set was established:
- Not applicable/Not specified. As mentioned above, this device does not utilize a training set in the way an AI algorithm does.

Summary

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K03 3712

DEC 2 3 2003

510(k) Summary of Safety & Effectiveness

(as required by 21 CFR 807.92c)

Date Prepared:

December 16, 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 with IDS5/mx.net
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:	K0033088
Device:	Sectra IDS5 Radiology Workstation - Version 10.

Device Description:

Indications for Use:

Device options make possible mammography reading, 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.

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Technological Characteristics:

The IDS5 Radiology Workstation with IDS5/mx.net 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 Radiology Workstation with IDS5/mx.net 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 re-transmission 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.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a circular design with the department's name encircling an emblem. The emblem consists of a stylized caduceus-like symbol, representing health and medicine, with three intertwined strands.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Sectra Imtec AB % Mr. Carl Alletto OTech, Inc. 1600 Manchester Way CORINTH TX 76210

DEC 2 3 2003

Re: K033712

Trade/Device Name: Sectra IDS5 Radiology Workstation Version 10.1 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: 90 LLZ Dated: November 21, 2003 Received: December 1, 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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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

Page 2

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510(k) Number: Ko 3 3712

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

Indications For Use:

Device options make possible mammography reading, 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.

David A. Symm

(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)

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).