syngo CT Oncology is a self-contained, non invasive image analysis software package designed to support the physician in routine diagnostic oncology, staging and follow-up. Flexible layouts and automated image registration facilitate the synchronous display and navigation of multiple datasets for viewing multi-phase CT data and easy follow-up comparison. The application provides a range of interactive tools specifically designed for segmentation and volumetric analysis of lesions and includes dedicated tools to support the physician in lung, liver and lymph node assessment in CT data. Dedicated workflowsupport and integrated, accumulative reporting help to track lesions and their changes in e.g. size, shape and enhancement pattern over time. syngo CT Oncology also facilitates functional imaging offering fusion with other modalities such as PET data. It also features syngo LungCAD for detecting small lung nodules (PMA-approved).

Device Description

syngo CT Oncology is a self-contained, non invasive image analysis software package designed to fast-track routine diagnostic oncology, staging and follow-up. Flexible layouts and automated image registration facilitate the synchronous display and navigation of multiple datasets for viewing multi-phase CT data and easy follow-up comparison. The application provides a range of automated tools specifically designed to support physicians in the segmentation and volumetric evaluation of suspicious lesions including dedicated tools for lung, liver and lymph node assessment in CT data. Dedicated workflow-support and integrated, accumulative reporting allow to track lesions and their changes in e.g. size, shape and enhancement pattern over time. syngo CT Oncology also facilitates functional imaging offering fusion with other modalities such as PET data. It also features syngo LungCAD for detecting small lung nodules (PMA-approved).

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study information for "syngo CT Oncology - Software Package":

Acceptance Criteria and Device Performance Study: syngo CT Oncology - Software Package (K071310)

The provided 510(k) summary for syngo CT Oncology (K071310) does not contain specific acceptance criteria or a detailed study designed to prove the device meets such criteria in terms of quantitative performance metrics (e.g., sensitivity, specificity, accuracy against a gold standard).

Instead, the submission primarily focuses on establishing substantial equivalence to existing legally marketed predicate devices. The "safety and effectiveness information" presented is geared towards demonstrating that the new device is as safe and effective as the predicate devices, rather than quantifying its performance against predefined benchmarks.

The document states:

"The device labeling 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."

These statements describe the general approach to ensuring safety and effectiveness through good manufacturing practices, risk management, and adherence to standards, but they do not define specific performance-based acceptance criteria for the image analysis software's diagnostic capabilities.

Because the submission relies on substantial equivalence and general safety/effectiveness claims rather than a detailed performance study with defined criteria, much of the requested information cannot be extracted directly from the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided document, specific quantitative acceptance criteria and reported device performance (e.g., sensitivity, specificity, or volumetric accuracy against a ground truth) are NOT explicitly stated.

The document emphasizes general safety and effectiveness through risk management and adherence to standards. The substantial equivalence argument implies that the device performs at least as well as the predicate devices for its intended use, but no quantitative performance metrics are given for either the new device or the predicates in this summary.

Acceptance Criteria (Explicitly Stated in Document)	Reported Device Performance (Explicitly Stated in Document)
None explicitly stated as quantitative performance metrics. The core criterion is demonstrating substantial equivalence to predicate devices, supported by: - Instructions for safe and effective use - Hazard analysis and risk control - Adherence to industry practice and standards	None explicitly stated as quantitative performance metrics. The device is deemed "substantially equivalent" to predicate devices, implying comparable safety and effectiveness for its intended use.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not specified.
Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

Number of Experts: Not specified.
Qualifications of Experts: Not specified.

4. Adjudication Method for the Test Set

Adjudication Method: Not specified.

5. Multi-Reader-Multi-Case (MRMC) Comparative Effectiveness Study

MRMC Study Done?: No, an MRMC comparative effectiveness study is not mentioned or described in this 510(k) summary for the syngo CT Oncology software package itself. The document mentions "syngo LungCAD for detecting small lung nodules (PMA-approved)", which might have undergone such studies separately under its PMA, but this 510(k) is for the broader CT Oncology package.
Effect Size of Human Reader Improvement with AI vs. without AI Assistance: Not applicable, as no MRMC study for this specific device is described here.

6. Standalone (Algorithm Only) Performance Study

Standalone Study Done?: Not described. The submission focuses on the device as a "software package designed to support the physician" (human-in-the-loop) and establishing substantial equivalence rather than independent algorithmic performance.

7. Type of Ground Truth Used

Type of Ground Truth: Not specified. Since no specific performance study is detailed, the method for establishing ground truth is not mentioned.

8. Sample Size for the Training Set

Sample Size for Training Set: Not specified. The document does not describe the development or training of an AI algorithm in terms of data sets.

9. How the Ground Truth for the Training Set Was Established

Ground Truth Establishment for Training Set: Not specified.

Summary

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Summary

K071310
JUN - 8 2007

SECTION 9 510(k) SUMMARY

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 l.

1. Device Name and Classification

syngo CT Oncology - Software Package Product Name: Classification Name: Accessory to Computed Tomography System Classification Panel: Radiology 21 CFR §892.1750 CFR Section: Device Class: Class II Product Code: 90 JAK

2. lmporter/Distributor Establishment:

Registration Number: 2240869

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

Manufacturing Facility: 3.

Siemens AG Wittelsbacherplatz 2 D-80333 Muenchen, Germany

4. Contact Person:

Dr. Kristin Frowein Regulatory Submissions Specialist Siemensstr.1; D-91301 Forchheim +49 9191 18-9638 Phone: +49 9191 18-9782 Fax:

5. Date of Preparation of Summary: January 25, 2007

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II. SAFETY AND EFFECTIVENESS INFORMATION SUPPORTING THE SUBSTANTIAL EQUIVALENCE DETERMINATION

General Safety and Effectiveness Concerns 6.

The device labeling 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.

7. Substantial Equivalence

The syngo CT Oncology software package that is addressed in this premarket notification, is substantially equivalent to the following commercially available software package:

Manufacturer	Product	510(k)	Clearance date
1. Siemens AG	LungCARE CTSW Package	K022013	07/16/2002
2. Edda Technology, Inc.	IQQA-Liver	K061696	11/13/2006
3. GE Medical Systems	Advantage Windows	K963345
	Tissue Volume Option		10/18/1996
4. Siemens AG	syngo Multimodality	K010938	06/26/2001
	Workstation
	(feature: Image Fusion)

Device Description and Intended Use: 8.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows a circular logo with text around the perimeter and a symbol in the center. The text reads "HEALTH & HUMAN SERVICES - USA". The symbol in the center appears to be three stylized lines or curves, possibly representing a stylized bird or abstract design.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

Siemens AG Medical Solutions % Mr. Stefan Preiss Responsible Third Party Official TÜV SÜD America, Inc. 1775 Old Highway 8 N.W., Suite 104 NEW BRIGHTON MN 55112-1891

Re: K071310

Trade/Device Name: syngo CT Oncology - Software Package Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: May 22, 2007 Received: May 25, 2007

Dear Mr. Preiss:

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 (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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Image /page/2/Picture/9 description: The image shows a circular logo with the text "1896-1996" at the top and "Centennial" at the bottom. In the center of the logo, there are the letters "PA" in a stylized font. Below the word "Centennial" are four stars arranged in a horizontal line. The logo appears to be a commemorative emblem for a centennial celebration.

noting Public Health

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Page 2 -

Enclosure

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.

This letter will allow you to begin marketing your device as described in your Section 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:

21 CFR 876.xxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 894.xxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, 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/cdrlvindustry/support/index.html.

Sincerely yours,

Nancy Cbrogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

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SIEMENS

Indication for Use

SECTION 3

INDICATION FOR USE

510(k) Number (if known):

Device Name:

syngo CT Oncology - Software Package

Indications for Use:

Prescription Use	X
(Part 21 CFR 801 Subpart D)	AN

ND/OR

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

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

OF NEEDED)

concurrence of CDRH, Office of Device Evaluation (ODE)

Helstener

on Sign-Off Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number

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.