The Sectra IDS5 device is intended for the manipulation and displaying of medical 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.

Lossy compressed mammographic images are not intended for diagnostic review. Mammographic images should only be viewed with a monitor approved by FDA for viewing mammographic images.

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

Device Description

The Sectra IDS5 Workstation is mainly a software product. It is used for visualization and processing of digital medical images. The IDS5 is used as a client together with a Sectra provided server (Class I Exempt). The system runs on PCs under the Windows operating systems. Most notably two or more monitors are used.

The Sectra IDS5 Workstation is in fact a family of devices, including several workstations or types of workstations, e.g. the following:

Primary diagnostics workstation and the most powerful version of IDS5 -. IDS5/dx.net. It contains tools for assisting advanced users, e.g. the radiologists, in making a diagnosis.
Dedicated workstation for mammography IDS5/mx.net. It has all functionality as an . IDS5/dx.net but with an additional mammography package. Reading of mammographic images shall only be conducted with IDS5/mx.net.
Quality assurance workstation, mainly used by the technologists to prepare the images . for the reviewing radiologist.
Clinicians workstation used by the clinicians within the hospital to view the medical . images and to read the report.
. "Web" workstation that can be used by remote clinics to view images and reports.
"At-home" workstation that can be used by users, e.g. radiologists, over a low . bandwidth connection.

AI/ML Overview

The provided document (K051315) is a Special 510(k) submission for the Sectra IDS5 Workstation, which is primarily a software product for visualizing and processing digital medical images. However, the document does not contain specific acceptance criteria or a detailed study proving the device meets those criteria with quantitative performance metrics.

Instead, it's a "Substantial Equivalence" submission, which means the manufacturer is asserting that their new device is as safe and effective as a legally marketed predicate device (in this case, another version of the Sectra IDS5 Workstation, K050196). This type of submission often relies on demonstrating that the new device has "technological characteristics" and "performance data" that are similar to the predicate, rather than conducting new, large-scale clinical studies with specific performance targets.

Here's a breakdown of the information that is available based on your request, and where the document is lacking for other points:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria: Not explicitly stated as quantitative performance metrics. The implicit acceptance criteria appear to be substantial equivalence to the predicate device.
Reported Device Performance:
- Developed according to ISO 9001:2000.
- Complies with ACR/NEMA Digital Imaging Communications in Medicine (DICOM) version 3.0.
- Functions as an Image Processing System (LLZ).
- The document implies that the device performs its intended functions (image manipulation and displaying, mammography reading, etc.) reliably and safely, similar to the predicate.

Acceptance Criteria (Implicit)	Reported Device Performance (as stated in the document)
Substantially equivalent to predicate device (K050196)	"Based on the information supplied in this Special 510(k), we conclude that the subject device is safe, effective, and substantially equivalent to the predicate device."
Compliance with relevant standards	Developed according to ISO 9001:2000. Complies with ACR/NEMA Digital Imaging Communications in Medicine version 3.0.
Safe and effective visualization/processing of medical images	"The Sectra IDS5 Workstation is mainly a software product. It is used for visualization and processing of digital medical images."
Appropriate for diagnostic interpretation by medical professionals	"Images and information being reviewed, processed, relayed, and or transmitted are interpreted by a physician or trained medical personnel..."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not provided. The document does not describe a test set or any specific data used for a performance study. This is typical for a 510(k) where substantial equivalence is claimed based on compliance with standards and functional similarity to a predicate.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable/Not provided. No explicit test set or ground truth establishment process is described in this document. The device is a viewer/processor, and its "performance" is primarily assessed against technical standards and functional equivalence, not diagnostic accuracy requiring ground truth. The primary diagnostics workstation (IDS5/dx.net) "contains tools for assisting advanced users, e.g. the radiologists, in making a diagnosis," but the performance of this assistance is not quantified here.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable/Not provided. No adjudication method is described as there is no specific test set or diagnostic study outlined.

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

No. This document predates widespread AI assistance in such systems and does not describe any MRMC study or AI-related performance enhancement. The purpose of this device is image display and processing, not AI-driven diagnostic assistance.

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

No. The device is an image display and processing workstation that is inherently designed for "human-in-the-loop" operation. The document explicitly states: "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."

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

Not applicable/Not provided. No ground truth is described as no diagnostic performance study of the device itself (beyond its functional capabilities and adherence to standards) is detailed.

8. The sample size for the training set

Not applicable/Not provided. This document does not describe any machine learning component or a "training set" in the context of AI.

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

Not applicable/Not provided. As there's no described training set, there's no ground truth establishment process for it.

In summary:

This document is a regulatory submission focused on demonstrating "substantial equivalence" of the Sectra IDS5 Workstation to a previously cleared predicate device, based on shared technological characteristics, adherence to quality management systems (ISO 9001:2000), and compliance with industry standards (DICOM). It explicitly states that "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." Therefore, it does not contain the detailed performance study data, acceptance criteria (in terms of quantitative metrics), or ground truth establishment methods typically associated with AI/CADe devices or diagnostic accuracy studies.

Summary

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K051315

JUN 1 5 2005

510(k) Summary of Safety & Effectiveness

(as required by 21 CFR 807.92c)

Date Prepared:

May 12, 2005

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 Workstation
Software version:	10.2
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:	K050196
Device:	Sectra IDS5 Workstation

Device Description:

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The Sectra IDS5 Workstation is in fact a family of devices, including several workstations or types of workstations, e.g. the following:

Primary diagnostics workstation and the most powerful version of IDS5 -. IDS5/dx.net. It contains tools for assisting advanced users, e.g. the radiologists, in making a diagnosis.
Dedicated workstation for mammography IDS5/mx.net. It has all functionality as an . IDS5/dx.net but with an additional mammography package. Reading of mammographic images shall only be conducted with IDS5/mx.net.
Quality assurance workstation, mainly used by the technologists to prepare the images . for the reviewing radiologist.
Clinicians workstation used by the clinicians within the hospital to view the medical . images and to read the report.
. "Web" workstation that can be used by remote clinics to view images and reports.
"At-home" workstation that can be used by users, e.g. radiologists, over a low . bandwidth connection.

Indications for Use:

The Sectra IDSS device is intended for the manipulation and displaying of medical 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.

Lossy compressed mammographic images are not intended for diagnostic review. Mammographic images should only be viewed with a monitor approved by FDA for viewing mammographic images.

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

Technological Characteristics:

The IDS5 Workstation runs under the Window 2000 and Windows XP operating system for PCs (as a minimum and depending upon system configuration)'. The requirements on hardware are quite ordinary for a system used for displaying images. Most notably up to four monitors can be used.

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.

| Windows NT is supported for IDS5/web and IDS5/cl.net only.

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Conclusion:

Similar to the predicate device, the IDS5 Workstation 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 Special 510(k), we conclude that the subject device is safe, effective, and substantially equivalent to the predicate device.

Pat And

Peter Andersson Regulatory Affairs Officer Sectra Imtec AB Linköping, Sweden

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the seal is a stylized image of three overlapping human figures, which are meant to represent the department's mission of protecting the health of all Americans and providing essential human services.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 5 2005

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

Re: K051315

Trade/Device Name: Sectra IDS5 Workstation Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: May 17, 2005 Received: May 23, 2005

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 (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 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 (0S) 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 $10(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 this letter:

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

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act 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/industry/support/index.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

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Kostsiz 510(k) Number:

Device Name: IDS5 Workstation 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.

Lossy compressed mammographic images are not intended for diagnostic review. Mammographic images should only be viewed with a monitor approved by FDA for viewing mammographic images.

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)

V Prescription Use (Per 21 CFR 801.109)

Over -The-Counter Use ________________________________________________________________________________________________________________________________________________________

Daniel h. Syzmm

Division Sign-C sion of Reproduct

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).