The Sectra IDS4 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 IDS4 v3.2 Image Display System is mainly a software product. It is used for visualization and processing of digital radiology images. The system runs under both Window NT and HP-UX operating systems and still provide a common "look and feel" on both platforms.. The requirements on hardware are quite ordinary for a system used for displaying images. Most notably two or more monitors are used.

AI/ML Overview

Here's an analysis of the provided 510(k) summary for the K991643 device, structured to answer your questions regarding acceptance criteria and the supporting study:

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided 510(k) summary, the acceptance criteria are primarily focused on safety, performance standards compliance, and substantial equivalence to a predicate device, rather than specific quantitative performance metrics for image interpretation (e.g., sensitivity, specificity). The reported device performance centers on its compliance with these standards and its functional equivalence.

Aspect of Acceptance Criteria	Reported Device Performance
Safety and Functional Equivalence to Predicate Device	"The IDS4 v3.2 system 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 Management Systems."
Error Detection	"The subject and predicate devices both use standard data communications controls to detect errors."
Compliance with Safety Standards (IEC)	"The subject device complies with IEC 950 - Safety of Information Technology Equipment."
Compliance with Electromagnetic Compatibility (EMC) Standards	"CISPR 22, class A - Electromagnetic Compatibility, IEC-801-2, IEC-801-3 - Electromagnetic Compatibility."
Compliance with Information Processing Standards	"IEEE 1003.1 - POSIX standard for Information Processing."
Compliance with FCC Regulations	"FCC Part 15 sub-part B class A."
Compliance with Network and Communication Standards	"IEEE 802.3 - Ethernet, LAN Interface Standard, ACR/NEMA Digital Imaging Communications In Medicine version 3.0."
Data Recovery Mechanisms	"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)."
Security Measures	"Passwords are required for operation and to protect against unauthorized use."
Substantial Equivalence Conclusion	"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."

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

The provided 510(k) summary does not mention a specific "test set" in the context of image analysis performance. The performance data presented refers to compliance with various technical and safety standards, not a clinical validation study with a defined dataset of patient images.

For this type of device (an image display system), the focus of the 510(k) is typically on demonstrating that the system accurately displays images and functions reliably according to its intended use and prevailing standards, rather than proving diagnostic accuracy.

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

This information is not applicable and not provided in the 510(k) summary. Since there's no mention of a clinical test set requiring expert interpretation for ground truth, there's no information about experts or their qualifications.

4. Adjudication Method for the Test Set

This information is not applicable and not provided in the 510(k) summary for the same reasons as point 3.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not mentioned or indicated in the provided 510(k) summary. This type of study is more common for AI/CADe devices that directly aid in diagnosis or detection, rather than a general image display system.

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

No, a standalone performance study was not mentioned. The device, an "Image Display System," is inherently a tool for human review and interpretation. The summary 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

The concept of "ground truth" as typically applied to diagnostic algorithms (expert consensus, pathology, outcomes data) is not applicable to the data provided in this 510(k) summary. The ground truth, in the context of this device, would be the accuracy and fidelity of image display and system functionality which is assessed through compliance with technical standards and internal testing.

8. The Sample Size for the Training Set

This information is not applicable and not provided. The device described is an "Image Display System" (software for visualization and processing) and does not inherently involve machine learning models that require a "training set" in the typical AI sense.

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

This information is not applicable and not provided for the same reasons as point 8.

Summary of Findings:

The K991643 510(k) summary for the "IDS4 v3.2 Image Display System" primarily focuses on demonstrating substantial equivalence to a predicate device (K971368) by showing compliance with relevant safety, technical, and communication standards. It explicitly states that human users (physicians, radiologists, etc.) are responsible for image interpretation. Therefore, the document does not contain information related to clinical performance studies, AI algorithms, training/test sets, expert ground truth establishment, or human-AI comparative effectiveness, as these types of studies are typically required for devices that provide diagnostic interpretations or automated analysis rather than merely displaying images.

Summary

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K991643

510(k) Summary of Safety & Effectiveness

(as required by 21 CFR 807.92c)

Date Prepared:

12 April 1998

Submitter's Information:

Sectra Imtec AB
Teknikringen 2
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:	IDS4 v3.2 Image Display System
Common Name:	Digital Imaging System
Classification Name:	System, Image Processing, Accessory

Predicate Device:

Applicant:	Sectra Imtec AB
510(k) Number:	K971368
Device:	IDS4 Image Display System

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.

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Technological Characteristics:

The IDS4 v3.2 system will run on Hewlett-Packard computers under HP-UX (Hewlett-Packard's version of Unix) and on Windows NT operating systems for PCs, (as a minimum and depending upon system configuration).

Performance Data:

The subject and predicate devices both use standard data communications controls to detect errors. The subject device complies with IEC 950 - Safety of Information Technology Equipment, CISPR 22, class A - Electromagnetic Compatibility, IEC-801-2, IEC-801-3 - Electromagnetic Compatibility, IEEE 1003.1 - POSIX standard for Information Processing, FCC Part 15 sub-part B class A, IEEE 802.3 - Ethernet, LAN Interface Standard, ACR/NEMA Digital Imaging Communications In Medicine version 3.0.

Conclusion:

Similar to the predicate device, the IDS4 v3.2 system 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 Management Systems. 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.

Peter Ander

Peter Andersson Regulatory Assurance Manager Sectra Imtec AB

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Rockville MD 20850

Food and Drug Administration

9200 Corporate Boulevard

1999 JUN

MENT OF HEAL

Peter Andersson Regulatory Assistance Manager Spectra Imtec AB Teknikringen 2 SE-582 32 Linkoping SWEDEN

RE:

K991643 IDS4 (Image Display System) Dated: May 11, 1999 Received: May 13, 1999 Regulatory Class: II 21 CFR 892.2050/Procode: 90 LLZ

Dear Mr. Andersson:

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 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). 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, 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 notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product 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 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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"(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/dsma/dsmamain.html".

Sincerely yours,

APT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number:

Device Name: IDS4 (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)

and Radiological Devi 510(k) Number _

Prescription Use(Per 21 CFR 801.109)	OR	Over ,-The-Counter Use
		(Optional Format 1-2-96)
	(Division Sign-Off)
	Division of Reproductive, Abdominal, ENT,

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).