The SOMATOM P30 systems are 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 angles 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 P30 is a whole body X-ray computed tomography systems, 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 provided document, a 510(k) summary for the SOMATOM P30 CT System, does not contain details about specific acceptance criteria or a study proving the device meets them, in the typical sense of a performance study for AI/CAD-like devices.

Instead, this document focuses on demonstrating substantial equivalence to a predicate device (Siemens SOMATOM Plus 4 with Volume Zoom (K982349)) and adherence to regulatory standards for medical imaging equipment.

Therefore, many of the requested sections about specific performance studies (sample size, experts, adjudication, MRMC, standalone performance, ground truth establishment) cannot be extracted from this document, as they are not present.

Here's a breakdown of what can be inferred or directly stated from the document, and where information is explicitly missing:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Inferred from regulatory requirements and substantial equivalence)	Reported Device Performance (As stated in the document)
Safety:
Meets Federal Diagnostic Equipment Performance Standard (21 CFR Subchapter J)	"All components...are certified to meet those requirements; and a product report as per 21 CFR § 1002.10 will be filed..."
Meets 21 CFR § 1020.30 and § 1020.33 (Diagnostic X-ray systems)	"All components...are certified to meet those requirements..."
Meets ELECTRICAL AND MECHANICAL SAFETY STANDARD IEC 60601-1	"The SOMATOM P30 is designed to meet the ELECTRICAL AND MECHANICAL SAFETY STANDARD IEC 60601-1"
Meets UL 187 X-RAY EQUIPMENT STANDARD FOR SAFETY	"The SOMATOM P30 is designed to meet...UL 187 X-RAY EQUIPMENT STANDARD FOR SAFETY."
Effectiveness (Imaging Capability):
Produce cross-sectional images of the body	"The SOMATOM P30 is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data..."
Function according to fan beam principle	"features a continuously rotating tube-detector system and functions according to the fan beam principle."
Perform patient management, data management, X-ray scan control, image reconstruction, and image archive/evaluation	"The system software is a command-based program used for patient management, data management, X-ray scan control, image reconstruction, and image archive/evaluation."
Substantially equivalent in design, material composition, energy source, and radiation characteristics to predicate device	"the SOMATOM P30 systems operating with SOMARIS/5 "syngo" software are substantially equivalent to the predicate device Siemens SOMATOM Plus 4 with Volume Zoom (K982349)"

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

Not applicable / Not mentioned. This document does not describe a clinical performance study using a test set of patient data, as would be typical for AI/CAD devices. The focus is on hardware and software system safety and functional equivalence to an existing CT system.

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 mentioned. As no clinical performance study involving a test set and ground truth establishment is described, this information is not present.

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

Not applicable / Not mentioned. No adjudication method is described as there is no test set or expert ground truth determination.

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 describes a CT scanner, not an AI or CAD device intended to assist human readers, so an MRMC study is not relevant and was not performed/described.

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

Not applicable / Not mentioned. This is a CT imaging system. Its "performance" is inherent in its ability to produce images, not in an algorithmic diagnostic output that would be evaluated in a standalone manner like an AI.

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

Not applicable / Not mentioned. Ground truth in the context of clinical accuracy is not discussed here, as the submission focuses on regulatory compliance and functional equivalence, not diagnostic accuracy studies.

8. The sample size for the training set

Not applicable / Not mentioned. The device is a CT scanner, not an AI algorithm trained on a dataset. The software performs image reconstruction and management, likely based on established algorithms and engineering, not machine learning from a "training set" of images in the typical AI sense.

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

Not applicable / Not mentioned. As there's no mention of a training set, there's no ground truth establishment for it.

Summary

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Page 1 of 2

Attachment 1

KD13522

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.

General Information I.

Device Name:	SOMATOM Project 30 Computed Tomography X-raySystems
Classification Name:	§ 892.1750:Computed tomography X-ray system
Proprietary Trade Name:	SOMATOM P30
Classification:	Class II
Performance Standard:	21 CFR Subchapter J,Federal Diagnostic X-ray Equipment Standard
Registration Number:	2240869
Address:	Siemens Medical Systems, Inc.186 Wood Avenue SouthIselin, N.J. 08830
Contact Person:	Praveen P. NadkarniTechnical Specialist, Regulatory SubmissionsPhone: (732) 321-4950 Fax: (732) 321-4841

II. Safety and Effectiveness Information Supporting the Substantial Equivalence Determination

Device Description:

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K013522
Page 2 of 2

Intended Use:

The SOMATOM P30 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.)

General Safety and Effectiveness Concerns:

All components of the SOMATOM P30 subject to the Federal Diagnostic Equipment Performance Standard and applicable regulations of 21CFR § 1020.30 and § 1020.33 are certified to meet those requirements; and a product report as per 21 CFR § 1002.10 will be filed with the Center for Devices and Radiological Health (CDRH). To minimize electrical, mechanical, and radiation hazards, Siemens adheres to recognized and established industry practice. The SOMATOM P30 is designed to meet the ELECTRICAL AND MECHANICAL SAFETY STANDARD IEC 60601-1 and UL 187 X-RAY EQUIPMENT STANDARD FOR SAFETY.

Substantial Equivalence:

In the opinion of Siemens Medical Systems, Inc., the SOMATOM P30 systems operating with SOMARIS/5 "syngo" software are substantially equivalent to the predicate device Siemens SOMATOM Plus 4 with Volume Zoom(K982349) and to currently marketed head and whole body X-ray computed tomography systems with respect to design, material composition, energy source and radiation characteristics.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird-like figure with three horizontal lines above it, representing the department's mission to protect the health of all Americans.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 0 7 2001

Siemens Medical Systems, Inc. % Mr. Reiner Krumme Division Manager, Medical Division TUV Rheinland of North America, Inc. 12 Commerce Road NEWTOWN CT 06470

Re: K013522

Trade/Device Name: SOMATOM P30 CT System Computed Tomography Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: 90 JAK Dated: October 17, 2001 Received: October 23, 2001

Dear Mr. Krumme:

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 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 (QS) 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 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 this 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" (21 CFR Part 807.97). 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

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NOV 0 7 2001

Attachment 2

Indication for use

510(k) Number (if known):

K013522

Device Name:

SOMATOM P30 CT Systems

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.)

(Please do not write below this line - continue on another page if needed)

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Concurrence of the CDRH, Office of Device Evaluation (ODE)

Nancy C Brogdon

Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K013522

Over-The-Counter Use OR Prescription Use (Per 21 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.