Syngo Dual Energy is designed to operate with Siemens Dual Source CT scanners. CT images taken at the same time, using two different kV levels, of the same anatomical region of a patient are used. Depending on the region of interest, contrast agents may be used. The differences in the energy dependence of the attenuation coefficient of the different materials provide information about the chemical composition of body materials. The images are combined to visualize and analyze information about anatomical and pathological structures.

The functionality of the syngo® Dual Energy applications are as follows:

Lung Nodules
Xenon (Lung Ventilation)
Monoenergetic
Brain Haemorrhage
Gout Evaluation
Lung Vessels
Heart PBV
Dual Energy Bone Removal
Cartilage, Tendon, Ligament
Lung Perfusion
Liver
Hard Plaques in Vessels
Kidney Stones

Device Description

Syngo Dual Energy is designed to operate with Siemens Dual Source CT scanners. CT images taken at the same time, using two different kV levels, of the same anatomical region or a pattern a le penting our trist egion of minterest contrast agentis may be useum int differences in the energy dependence of the attenuation coefficient of the different materials provide information about the chemical composition of body materials. The Images are combined to visualize and analyze information about anatomical and pathological structures.

The functionality of the syngo® Dual Energy applications are as follows:

Lung Nodules .
Xenon (Lung Ventilation) .
· Monoenergetic · · · ·
Brain Haemorrhage ●
Gout Evaluation .
. Lung Vessels
Heart PBV .
Dual Energv Bone Removal
Cartilage, Tendon, Ligament
Lung Perfusion .
Liver ●
Hard Plaques in Vessels
Kidney Stones

AI/ML Overview

Here's an analysis of the provided text regarding the syngo Dual Energy with extended functionality device:

Important Note: The provided document is a 510(k) summary for a medical device. These summaries are primarily focused on demonstrating substantial equivalence to a legally marketed predicate device rather than comprehensive clinical study reports that detail acceptance criteria and their fulfillment through rigorous testing. Therefore, much of the requested information (especially quantitative details about specific studies, sample sizes, and expert qualifications) is not present in the provided text. The document focuses on regulatory compliance and the device's intended use and features.

Acceptance Criteria and Device Performance (Based on Available Information)

The 510(k) summary does not explicitly list quantitative acceptance criteria in terms of performance metrics (e.g., sensitivity, specificity, accuracy thresholds). Instead, "acceptance" for a 510(k) comes from demonstrating substantial equivalence to predicate devices and ensuring the device is safe and effective for its intended use through standard engineering practices and risk management.

The "reported device performance" in this context refers to the functionality and intended use as described, implying that these functions are performed safely and effectively, as confirmed through internal verification and validation testing, which is a regulatory requirement.

Acceptance Criterion (Inferred from 510(k) Process)	Reported Device Performance (Summary of Functionality)
Device functions as intended for specified applications	Combined CT images from two kV levels to visualize and analyze anatomical and pathological structures.
Safe and effective for its intended use	Device labeling contains instructions for use, cautions, and warnings. Risk management (hazard analysis) and software V&V are implemented. Adheres to recognized industry practice and standards.
Substantially equivalent to predicate devices	Demonstrated equivalence to syngo Dual Energy (K073003), syngo Oncology (K071310), and SOMATOM DR I (K837107).
Enables analysis for specific clinical applications	Supported applications include: Lung Nodules, Xenon (Lung Ventilation), Monoenergetic, Brain Hemorrhage, Gout Evaluation, Lung Vessels, Heart PBV, Dual Energy Bone Removal, Cartilage/Tendon/Ligament, Lung Perfusion, Liver, Hard Plaques in Vessels, Kidney Stones.

Study Details (Information Not Explicitly Provided in the 510(k) Summary)

The 510(k) summary does not include the type of detailed study information typically found in clinical trial reports or performance validation studies. This document serves as a regulatory submission for substantial equivalence. Therefore, the following points will indicate what is not present and what can be inferred.

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not provided. The 510(k) summary does not detail specific test sets, their sample sizes, or data provenance for performance validation. This information would typically be part of internal verification and validation documents or clinical studies, which are not included in this public summary.
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 provided. Ground truth establishment, expert numbers, and qualifications are not disclosed in this summary.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not provided. Details on adjudication methods for any test data are not mentioned.
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:
- Not explicitly mentioned as a formal MRMC study for this device's performance. The document describes "syngo Dual Energy with extended functionality" as software operating with CT scanners. It focuses on the capabilities of the software to process dual-energy CT data for various applications. It does not present evidence of a comparative effectiveness study showing human reader improvement with or without this specific AI-like functionality. While the software provides "analysis information," the summary does not quantify an "AI assistance" effect size on human reader performance.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not explicitly detailed as a standalone performance study with metrics. The device is described as "designed to operate with Siemens Dual Source CT scanners" and as an aid to "visualize and analyze information." This implies its role is to generate processed images and data for human interpretation rather than making definitive diagnoses in a standalone capacity. Performance validation would likely involve ensuring the accuracy of the processed information it generates.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not provided. The type of ground truth used for any internal validation is not specified.
The sample size for the training set:
- Not applicable / Not provided. The term "training set" is typically associated with machine learning or AI models. While "syngo Dual Energy" processes data, the summary does not describe it as an AI model in the modern sense that would require a distinct "training set" for model learning in the same way. It's a software package that applies algorithms to CT data. If any component did involve machine learning (unlikely for a 2009 submission for this type of software), the training set size is not mentioned.
How the ground truth for the training set was established:
- Not applicable / Not provided. As above, a specific "training set" and its ground truth establishment are not discussed.

Summary of What the Document Provides:

The provided 510(k) summary focuses on demonstrating:

The device's intended use and functionality (specific applications like Lung Nodules, Gout Evaluation, etc.).
Its classification and regulatory pathway (Class II medical device, product code JAK).
Its substantial equivalence to several predicate devices.
The manufacturer's adherence to basic safety and effectiveness principles (risk management, V&V, industry standards).

It does not contain the detailed performance study results, acceptance criteria, sample sizes, expert qualifications, or ground truth methodologies that would typically be found in a comprehensive clinical validation report. For a 510(k) submission, the emphasis is on showing that the new device is as safe and effective as a legally marketed predecessor, primarily through technical comparison and established risk management, rather than novel clinical performance studies unless significant new indications or technology are introduced.

Summary

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1083524

Attachment 8

Summary

APR - 1 2009

510(k) - Summary

SIEMENS

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 Name and Classification 1.

Product Name:	syngo® Dual Energy with extended functionality
Classification Name:	Accessory to Computed Tomography System
Classification Panel:	Radiology
CFR Section:	21 CFR §892.1750
Device Class:	Class II
Product Code:	90 JAK

2. Importer/Distributor Establishment: Registration Number: 2240869

Siemens Medical Solutions, Inc. 51 Valley Stream Pkwy Malvern, PA 19355

3. Manufacturing Facility:

Siemens AG Medical Solutions Henkestrasse 127

D-91052 Erlangen, Germany

Contact Person: 4.
Mrs. Corrine McLeod

Date of Preparation of Summary: September 10th 2007 ട.

510(k) submission for SIEMENS ' syngo Dual Energy

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Summary

SIEMENS

SAFETY AND EFFECTIVENESS INFORMATION SUPPORTING THE SUBSTANTIAL II. EQUIVALENCE DETERMINATION

General Safety and Effectiveness Concerns: 6.

The device Iabeling contains instructions for use and any necessary cautions and warnings, to provide for safe and effective use of the device.

Risk management is ensured via a hazard analysis, which is used to identify potential hazards. These potential hazards are controlled via software development, verification and validation testing. To minimize electrical, mechanical, and radiation hazards, Siemens adheres to recognized and established industry practice and standards.

Substantial Equivalence: 7.

The syngo® Dual Energy software package that is addressed in this premarket notification, is substantially equivalent to the following commercially available Siemens Medical Systems devices :

Manufacturer	Product	510(k)	Clearance date
1. Siemens	syngo Dual Energy	K073003	02/07/2008
2. Siemens	syngo Oncology	K071310	06/08/2007
3. Siemens	SOMATOM DR I	K837107	03/09/1983

Device Description and Intended Use: 8.

Device Name: syngo® Dual Energy with extended functionality

The functionality of the syngo® Dual Energy applications are as follows:

Lung Nodules .
Xenon (Lung Ventilation) .
· Monoenergetic · · · ·
Brain Haemorrhage ●
Gout Evaluation .
. Lung Vessels
Heart PBV .
Dual Energv Bone Removal
Cartilage, Tendon, Ligament
Lung Perfusion .
Liver ●
Hard Plaques in Vessels
Kidney Stones

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with three lines representing its wings and body. The eagle is facing to the right.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR - 1 2009

Ms. Corrine McLeod Regulatory Affairs Specialist Siemens Medical Solutions USA, Inc. Corporate Headquarters 51 Valley Stream Parkway MALVERN PA 19355

Re: K083524

Trade/Device Name: syngo® Dual Energy with extended functionality Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system

Regulatory Class: II

Product Code: JAK

Dated: March 4, 2009

Received: March 16, 2009

Dear Ms. McLeod:

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 such 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.

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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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding os 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.

21 CFR 876.xxx	(Gastroenterology/Renal/Urology)	(240) 276-0115
21 CFR 884.xxx	(Obstetrics/Gynecology)	(240) 276-0115
21 CFR 892.xxx	(Radiology)	(240) 276-0120
Other		(240) 276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting -(MDR)) - please contact the Division of Surveillance -Systems at -240-276-3464. - You may obtain other general information on your responsibilities under the Act from the Division of Small Manufactures, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry.suppo/index.html.

Sincerely yours,

Janine M. Morris

anine M. Morris Acting Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Page 2

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Indication for use

510(k) Number: K083524

Device Name: syngo Dual Energy with extended functionality

The functionality of the syngo® Dual Energy applications are as follows:

Lung Nodules �
Xenon (Lung Ventilation)
Monoenergetic .
Brain Haemorrhage .
Gout Evaluation
Lung Vessels
Heart PBV
Dual Energy Bone Removal
Cartilage, Tendon, Ligament .
Lung Perfusion .
Liver .
Hard Plaques in Vessels
Kidney Stones

Prescription Use > (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use(Part 21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of the CDRH, Office of Device Evaluation (ODE)	Page ___ of ___
(Division Sign-Off)
Division of Reproductive, Abdominal and Radiological Devices
510(k) Number	K083524

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.