The Somatom Plus 4 with Volume Zoom package is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angels or spiral planes* taken at different angles. (*spiral planes: the axial planes resulted from the continuous rotation of detectors and x-ray tube, and the simultaneous translation of the patient.)

Device Description

The Siemens Somatom Plus 4 with Volume Zoom package is a whole body X-ray computed tomography scanner which features a continuously rotating tube-detector system and functions according to the fan beam principle. The system software is a command based program used for patient management, data management, X-ray scan control, image reconstruction, and image archive/evaluation.

AI/ML Overview

The Siemens Somatom Plus 4 with Volume Zoom package is a CT scanner, and the provided documentation focuses on its substantial equivalence to existing CT systems rather than a clinical study with detailed acceptance criteria and performance metrics typically associated with AI/CADe devices. Therefore, much of the requested information (like expert qualifications, adjudication methods, MRMC studies, effect size, etc.) is not applicable or available in this context.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Safety: Device meets Federal Diagnostic Equipment Performance Standard and applicable regulations of 21CFR § 1020.30 and § 1020.33.	The device is designed to meet the stated standards.
Safety: Device meets ELECTRICAL AND MECHANICAL SAFETY STANDARD IEC 601-1, +A1:1991, +A2:1995, and IEC 60601-1-2.	The device is designed to meet the stated standards.
Intended Use: Produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles.	The device is a whole-body X-ray computed tomography scanner used for whole body X-ray computed imaging.
Technological Equivalence: Substantially equivalent to Siemens SOMATOM Plus 4, GE CT/I, Elscint Twin Flash, and SOMATOM Plus 4 Power systems in commercial distribution.	(Implicit) The FDA's 510(k) clearance signifies acceptance of substantial equivalence, meaning the device performs similarly to predicate devices. Specific performance metrics (e.g., image resolution, dose, scan speed) are not explicitly provided in this summary but would have been part of the technical documentation reviewed by the FDA for substantial equivalence.

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

Not applicable. This submission is for a new feature (Volume Zoom package) on an existing CT scanner, demonstrating substantial equivalence to other CT scanners. It's not a performance study of a diagnostic algorithm based on a test dataset of patient cases. The evaluation is focused on technical specifications and adherence to existing CT standards.

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

Not applicable. See point 2.

4. Adjudication method for the test set

Not applicable. See point 2.

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 a CT scanner, not an AI/CADe device that assists human readers.

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

Not applicable. This is a CT scanner, not a standalone algorithm.

7. The type of ground truth used

Not applicable (in the context of clinical performance data). The "ground truth" here is compliance with technical standards and performance characteristics of existing CT scanners for demonstrating substantial equivalence.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that requires a training set.

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

Not applicable. See point 8.

Summary

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IEMENS

SEP 3 0 1998

K982349

Attachment 1

Summary of Safety and Effectiveness

This summary of 510(k)-safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

I. General Information

Device: Somatom Plus 4 with Volume Zoom package Trade Name: Common Name: CT Scanner Classification Name: § 892.1750: Computed tomography X-ray system Class II Classification: Performance Standard:21 CFR Subchapter J, Federal Diagnostic X-ray Equipment Standard Establishment: Siemens Medical Systems, Inc. Address: 186 Wood Avenue South Iselin, N.J. 08830 Registration Number: 2240869 Contact Person: Kathleen M. Rutherford Manager, Regulatory Submissions (732) 321-4779 Date of Summary Preparation: 6/29/98

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SIEMEN

II. Safety and Effectiveness Information Supporting the Substantial Equivalence Determination

Device Description:

Intended Use:

The SOMATOM Plus 4 with Volume Zoom package is used for whole body X-ray computed imaging.

Technological Characteristics:

The SOMATOM Plus 4 with Volume Zoom package is a whole body X-ray computed tomography scanner, which features a continuously rotating tube-detector system and functions according to the fan beam principle. The system is based on the existing SOMATOM Plus 4 system (for further details see section 3). The Volume Zoom functionality will be marketed as an optional package for the existing SOMATOM Plus 4 system and will also be offered as an upgrade to already installed systems. The system with SOMARIS/5 software.

General Safety and Effectiveness Concerns:

All components of the Somatom Plus 4 with Volume Zoom package subject to the Federal Diagnostic Equipment Performance Standard and applicable regulations of 21CFR $ 1020.30 and § 1020.33 will meet those requirements; and an initial report as per 21 CFR & 1002.10 will be filed with the Center for Devices and Radiological Health (CDRH). The SOMATOM is designed to meet the ELECTRICAL AND MECHANICAL SAFETY STANDARD IEC 601-1, +A1:1991, +A2:1995, and IEC 60601-1-2.

Substantial Equivalence:

The Somatom Plus 4 with Volume Zoom package operating with SOMARIS/5 software is substantially equivalent to the Siemens SOMATOM Plus 4, GE CT/I, Elscint Twin Flash and SOMATOM Plus 4 Power systems in commercial distribution.

Kathleen Rutherford

Manager, Regulatory Submissions

7/1/98
Date

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Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 3 0 1998

Alicia Juergensen Technical Specialist Siemens Medical Systems, Inc. 186 Wood Ave. South Iselin, NJ 08830

K982349

Re:

Somatom Plus 4 with Volume Zoom CT Scanners June 29, 1998 Dated: Received: July 6, 1998 Regulatory class: II 21 CFR 892.1750/Procode: 90 JAK

Dear Ms. Juergensen:

We have reviewed your Section 510%) 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 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 equivalience with the Current Good Manufacturing Practice requirements, as set forth in the Ouality System Regulation (OS) 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 vour 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/dsmaldsmam.html".

Sincerely yours,

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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Attachment 2

Indication for use

510(k) Number (if known):

K982349

Device Name:

Somatom Plus 4 with Volume Zoom package

Indication for use:

(*spiral planes: the axial planes resulted from the continuous rotation of detectors and x-ray tube, and the simultaneous translation of the patient.)

Caml l. Segon
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number

cription Use 1 CFR 801.109)

Regulation Number and Section

§ 892.1750 Computed tomography x-ray system.

(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.