The Sectra AB WISE II Image Management System device is intended for the management and displaying of x-ray images, other radiological objects and information. It can manage images from different modalities, single and multiple file servers, and interfaces to various Radiological Information Systems (RIS), image storage and printing devicesusing DICOM or similar interface standards.

Device Description

WISE II is a system for managing digital radiological images. This includes image storage and searching for images in archives and retrieving image for re-consultation. WISE II generally provides functions to:

Access information related to requests, examinations and images .
Create, move, copy and delete folders and examination folders .
Add images to and delete images from examinations .
File examinations to the archives and retrieve examinations from the archives ●
Retrieve examinations from DICOM conformant archives ●
Manage images stored on multiple file servers
Provide services (DICOM, WWW, etc) to clients via WISE gateways ●
. Interface RIS for relational integrity
. Send and retrieve images (teleradiology)

AI/ML Overview

The provided text does not contain detailed information about specific acceptance criteria and a study proving a device meets these criteria in the way typically found in modern medical device submissions (e.g., an AI-powered diagnostic tool).

The document is a 510(k) summary for the "WISE II Image Management System," a device described as a "Digital Imaging System" for managing radiological images. The primary focus of this submission is to demonstrate substantial equivalence to a predicate device (WISE Image Management System, K971451), rather than proving specific performance metrics of an AI algorithm against a ground truth dataset.

Therefore, many of the requested details (like sample size for test sets, number of experts for ground truth, MRMC studies, standalone performance of an algorithm, and training set information) are not applicable or not available in this document.

Here's an attempt to answer the questions based only on the provided text, indicating where information is absent:

Acceptance Criteria and Study for Sectra WISE II Image Management System (K983447)

This 510(k) submission primarily focuses on demonstrating substantial equivalence to a predicate device (Sectra WISE Image Management System, K971451) for an image management system, not on proving the performance of an AI algorithm against specific clinical outcomes or established ground truth with quantified metrics. Therefore, many of the requested parameters related to AI performance studies are not present in this document.

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

The document does not specify quantitative acceptance criteria or reported performance metrics in the way one would for a diagnostic AI algorithm (e.g., sensitivity, specificity, AUC). Instead, the performance is described in terms of compliance with industry standards and safety regulations, and functional capabilities.

Acceptance Criteria (Implied)	Reported Device Performance
Safety and Effectiveness (General 510(k) Requirement)	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."
Substantial Equivalence to Predicate	The device is deemed substantially equivalent to the WISE Image Management System (K971451) based on shared indications for use and technological characteristics.
Functional Capabilities (Image Management)	- Access information related to requests, examinations and images.- Create, move, copy and delete folders and examination folders.- Add images to and delete images from examinations.- File examinations to the archives and retrieve examinations from the archives.- Retrieve examinations from DICOM conformant archives.- Manage images stored on multiple file servers.- Provide services (DICOM, WWW, etc) to clients via WISE gateways.- Interface RIS for relational integrity.- Send and retrieve images (teleradiology).
Compliance with Data Communications Controls	Both subject and predicate devices "use standard data communications controls to detect errors."
Compliance with Safety Standards	Complies with IEC 950 - Safety of Information Technology Equipment.
Compliance with Electromagnetic Compatibility (EMC) Standards	Complies with CISPR 22, class A - Electromagnetic Compatibility, IEC-801-2, IEC-801-3 - Electromagnetic Compatibility, FCC Part 15 sub-part B class A.
Compliance with Information Processing Standards	Complies with IEEE 1003.1 - POSIX standard for Information Processing.
Compliance with Network Standards	Complies with IEEE 802.3 - Ethernet, LAN Interface Standard.
Compliance with Medical Imaging Standards	Complies with ACR/NEMA Digital Imaging Communications In Medicine version 3.0 (DICOM).
Security Measures	"Passwords are required for operation and to protect against unauthorized use."
Error Recovery	"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)."

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

Sample Size (Test Set): Not applicable / Not provided. This submission is for an image management system, not a diagnostic algorithm that would typically have a test set of medical images for performance evaluation.
Data Provenance: Not applicable / Not provided.

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. The device manages images; it does not perform automated diagnoses requiring expert-established ground truth for a test set. The document notes 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."

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

Not applicable / Not provided.

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 is not an AI-assisted diagnostic device, but an image management system. Therefore, an MRMC study and related effect size are not applicable.

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

No. This device's function is to manage and display images for human interpretation, not to provide standalone algorithmic diagnoses.

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

Not applicable / Not provided. Ground truth is not a concept explicitly applied to the performance evaluation described for this type of device.

8. The sample size for the training set

Not applicable / Not provided. This device is not an AI algorithm that undergoes a training phase with a labeled dataset.

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

Not applicable / Not provided.

Summary

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Sectra Document Number: 3-98.852-2.0

OCT 2 9 1998

K983447

510(k) Summary of Safety & Effectiveness

(as required by 21 CFR 807.92c)

Date Prepared:

25 September 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:	WISE II Image Management System
Common Name:	Digital Imaging System
Classification Name:	System, Digital Image Communication, Accessor

Predicate Device:

Applicant:	Sectra Imtec AB
510(k) Number:	K971451
Device:	WISE Image Management System

Device Description:

Access information related to requests, examinations and images .
Create, move, copy and delete folders and examination folders .
Add images to and delete images from examinations .
File examinations to the archives and retrieve examinations from the archives ●
Retrieve examinations from DICOM conformant archives ●
Manage images stored on multiple file servers
Provide services (DICOM, WWW, etc) to clients via WISE gateways ●
. Interface RIS for relational integrity
. Send and retrieve images (teleradiology)

Indications for Use:

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

Technological Characteristics:

The WISE II system will run on Hewlett-Packard computers under HP-UX (Hewlett-Packard's version of Unix), SUN Micro System computers under SOLARIS (SUN'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 WISE II 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 Imagement Systems. 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.

Pet Ander

Peter Andersson Regulatory Assurance Manager Sectra Imtec AB

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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 consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around it. Inside the circle is an abstract symbol that resembles an eagle or a bird in flight, composed of three stylized human profiles facing to the right.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 29 1998

Herman Oosterwijk President c/o Otech Inc. 6741 Grant Lane Plano, TX 75024

Re: K983447

Wise (II) Image Management System Dated: September 25, 1998 Received: September 30, 1998 Regulatory class: I 21 CFR 892.2010/Procode: 90 LMB

Dear Mr. Oosterwijk:

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 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 decemination 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 riths 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/cdri/dsma/dsmamain.html".

Sincerely yours,

Lillian Yih, Ph.D.

Lillian Yin, Ph.D. Director, Division of Reproductive Abdominal, Ear, Nose and Throa and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number:

Device Name: WISE Image Management System

Indications For Use:

The Sectra WISE Image Management System device is intended for the management and displaying of x-ray images, other radiological objects, and information.

It can manage images from different modalities, single and multiple file servers, and interfaces to various Radiological Information Systems (RIS), image storage and printing devices using DICOM or similar interface standards.

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	✓	Over-The-Counter Use
(Per 21 CFR 801.109)		(Optional Format 1-2-96)
	(Division Sign-Off)
	Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number	K983447

Regulation Number and Section

§ 892.2010 Medical image storage device.

(a)
Identification: A medical image storage device is a hardware device that provides electronic storage and retrieval functions for medical images. Examples include electronic hardware devices employing magnetic and optical discs, magnetic tapes, and digital memory.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 892.9.