The SOMATOM Project 10 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 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 Project 10 systems are a whole body X-ray computed tomography scanners, 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

This submission is a 510(k) premarket notification for the Siemens SOMATOM Project 10 Computed Tomography X-ray Systems. The document declares the device's substantial equivalence to previously marketed devices (Siemens SOMATOM Plus 4 and General Electric Hispeed systems).

Given the nature of a 510(k) for an established radiological imaging device like a CT scanner from 1999, the "acceptance criteria" and "study" are not presented in the same way as they would be for a novel AI/ML-driven diagnostic device undergoing recent FDA clearance.

Here's a breakdown based on the provided text, highlighting the differences in evaluation for this type of device:

A table of acceptance criteria and the reported device performance

There isn't a table of specific acceptance criteria in terms of clinical performance metrics (e.g., sensitivity, specificity, AUC) for the SOMATOM Project 10 system, nor are there reported device performance metrics in that context.

For CT scanners of this era, "acceptance criteria" primarily relate to:
- Compliance with established performance standards: "All components of the SOMATOM Project 10 systems subject to the Federal Diagnostic Equipment Performance Standard and applicable regulations of 21CFR § 1020.30 and § 1020.33 are certified to meet those requirements."
- Safety standards: "The SOMATOM is designed to meet the ELECTRICAL AND MECHANICAL SAFETY STANDARD IEC 601-1 and UL 187 X-RAY EQUIPMENT STANDARD FOR SAFETY."
- Substantial Equivalence: The primary "performance" reported is its substantial equivalence to existing, legally marketed predicate devices (Siemens SOMATOM Plus 4 and General Electric Hispeed (DX/i and LX/i) systems). This means its intended use, technological characteristics, and safety/effectiveness profiles are comparable to those already approved.
Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

There is no test set, data provenance, or specific clinical study with a sample size mentioned for this 510(k) submission. Approval for a CT scanner in 1999 primarily relied on demonstrating adherence to engineering and safety standards, and demonstrating substantial equivalence to predicate devices, rather than a prospective clinical trial with a defined test set of patients.
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)

This is not applicable as there was no test set requiring ground truth establishment by experts for this type of device approval.
Adjudication method (e.g., 2+1, 3+1, none) for the test set

This is not applicable as there was no test set requiring adjudication.
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 MRMC study was performed. This device is a CT scanner, not an AI-driven image analysis tool. The concept of "human readers improve with AI" is not relevant to this submission.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This is not applicable. The SOMATOM Project 10 is an imaging device, not a standalone algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

No clinical ground truth in the sense of comparing device output to a definitive medical diagnosis (like pathology) was used for this 510(k). The "ground truth" for this submission revolves around engineering specifications, safety standards, and documented equivalency to predicate devices.
The sample size for the training set

This is not applicable. The device is a CT scanner, not an AI/ML algorithm that requires a training set.
How the ground truth for the training set was established

This is not applicable as there was no training set.

Summary for Siemens SOMATOM Project 10 Computed Tomography X-ray Systems (K991764):

The provided documentation details a 510(k) premarket notification for a Computed Tomography X-ray System from 1999. In the context of regulatory approval for such a device at that time, "acceptance criteria" and "studies" are fundamentally different from those applied to modern AI/ML-driven diagnostic software.

For K991764, the primary "study" was demonstrating Substantial Equivalence to legally marketed predicate devices, coupled with compliance with established safety and performance standards. There were no specific clinical performance studies (e.g., sensitivity, specificity trials) with defined patient test sets, ground truth, or expert adjudicators explicitly detailed or required for this type of device in a 510(k) notification in 1999.

Table of Acceptance Criteria and Reported Device Performance (as inferred from the document):

Acceptance Criteria Category	Specific Criterion / Requirement	Reported Device Performance / Compliance
Intended Use Equivalence	Produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from axial or spiral planes.	"The SOMATOM P10 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 angels or spiral planes* taken at different angles." (Matches predicate functionality)
Technological Characteristics Equivalenc	Continuously rotating tube-detector system, fan beam principle, SOMARIS/4.5 software, whole body scanner.	"The SOMATOM Project 10 systems are whole body X-ray computed tomography scanners, which features a continuously rotating tube-detector system and functions according to the fan beam principle. The systems are based on the existing SOMATOM Plus 4 system... The system will operate with SOMARIS/4.5 software." (Equivalent to predicate)
Federal Performance Standard Compliance	Adherence to 21 CFR Subchapter J, Federal Diagnostic X-ray Equipment Standard (21CFR § 1020.30 and § 1020.33).	"All components...are certified to meet those requirements; and an initial report as per 21 CFR § 1002.10 will be filed..."
Electrical & Mechanical Safety Standards	Compliance with IEC 601-1 and UL 187 X-RAY EQUIPMENT STANDARD FOR SAFETY.	"The SOMATOM is designed to meet the ELECTRICAL AND MECHANICAL SAFETY STANDARD IEC 601-1 and UL 187 X-RAY EQUIPMENT STANDARD FOR SAFETY."
Substantial Equivalence	Demonstrated equivalence in safety and effectiveness to legally marketed predicate devices.	"The SOMATOM Project 10 systems operating with SOMARIS/4.5 software are substantially equivalent to the Siemens SOMATOM Plus 4 and General Electrics Hispeed (DX/i and LX/i) systems in commercial distribution."

Additional Details:

Sample Size (Test Set): Not applicable for this type of 510(k) submission.
Data Provenance: Not applicable.
Number of Experts/Qualifications: Not applicable.
Adjudication Method: Not applicable.
MRMC Comparative Effectiveness Study: Not performed.
Standalone Performance Study (Algorithm Only): Not applicable, as this is an imaging device, not a standalone algorithm.
Type of Ground Truth: Not directly applicable in the clinical diagnostic sense. "Ground truth" was established by adherence to engineering specifications, safety standards, and comparison to the design and performance of predicate devices.
Training Set Sample Size: Not applicable.
Ground Truth for Training Set: Not applicable.

Summary

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SIEMENS

AUG 17 1999

K991764

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.

General Information I.

Device Name:	SOMATOM Project 10 Computed Tomography X-raySystems
Classification Name:	& 892.1750:Computed tomography X-ray system
Propriety Trade Name:	SOMATOM Star / SOMATOM Sprinter
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:	Kathleen M. RutherfordManager, Regulatory Submissions(732) 321-4779

Date of Summary Preparation: 5/20/99

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II. Safety and Effectiveness Information Supporting the Substantial Equivalence Determination

Device Description:

Intended Use:

The SOMATOM P10 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 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.)

Technological Characteristics:

The SOMATOM Project 10 systems are whole body X-ray computed tomography scanners, which features a continuously rotating tube-detector system and functions according to the fan beam principle. The systems are based on the existing SOMATOM Plus 4 system (for further details see chapter 2). The system will operate with SOMARIS/4.5 software.

General Safety and Effectiveness Concerns:

All components of the SOMATOM Project 10 systems 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 an initial 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 The SOMATOM is designed to meet the ELECTRICAL AND MECHANICAL practice. SAFETY STANDARD IEC 601-1 and UL 187 X-RAY EQUIPMENT STANDARD FOR SAFETY.

Substantial Equivalence:

The SOMATOM Project 10 systems operating with SOMARIS/4.5 software are substantially equivalent to the Siemens SOMATOM Plus 4 and General Electrics Hispeed (DX/i and LX/i) systems in commercial distribution.

Kattlen Rutherford

Kathleen Rutherford Manager, Regulatory Submissions

5/21/99
Date

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 7 1999

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

RE:

K991764 Somatom Project 10-CT Scanners Dated: May 20, 1999 Received: May 24, 1999 Regulatory Class: II 21 CFR 892.1750/Procode: 90 JAK

Dear Ms. Juergensen:

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 redassified 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 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,

[signature]

CAPT 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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Attachment 2

Indication for use

510(k) Number (if known):

K991764

Device Name:

SOMATOM Project 10 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.)

Daniel A. Szymon
(Division Sign-Off)

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

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.