syngo Neuro DSA CT is a dedicated post-processing application which allows removing bone structures from CT Angiography (CTA) data sets of the cerebral vasculature. Bone removal is based on a bone mask created from an additional non enhanced CT (NECT) scan that was three-dimensionally registered to the CTA data set.

Syngo Neuro DSA CT facilitates the diagnosis of the cerebral vasculature by removing interfering bone structures from CTA data. This particularly helps to delineate aneurysms and other vascular diseases in the area of the skull base.

Device Description

AI/ML Overview

The provided text describes the syngo Neuro DSA CT device, its intended use, and its substantial equivalence to predicate devices, but does not contain details about specific acceptance criteria, a study proving those criteria were met, or the methodologies used to establish ground truth or evaluate performance.

Therefore, I cannot provide the requested information. The document focuses on regulatory submission (510(k) summary) rather than a detailed scientific study.

Here's what I can infer from the available text:

1. A table of acceptance criteria and the reported device performance: Not available.
2. Sample sized used for the test set and the data provenance: Not available.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not available.
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: Not available.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device description ("dedicated post-processing application which allows removing bone structures") suggests it's an algorithm, but specific standalone performance metrics are not given. The comparison is against predicate devices in terms of substantial equivalence, not performance metrics.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not available. The document talks about "verification and validation testing" as part of risk management, but doesn't specify the ground truth methodology for this testing.
8. The sample size for the training set: Not available.
9. How the ground truth for the training set was established: Not available.

The document states that "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." This indicates that some testing was performed to ensure safety and effectiveness, but the specifics of that testing (including acceptance criteria, sample sizes, ground truth procedures, and expert involvement) are not detailed in this 510(k) summary.

Summary

{0}------------------------------------------------

Summary

NOV - 4 2005

K053024
Attachment 8

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.

l. GENERAL INFORMATION

1. Device Name and Classification

Product Name: syngo Neuro DSA CT 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. lmporter/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 ' angen, Germany

4. Contact Person:

Mr. Rüdiger Körner Manager Regulatory Submissions Siemensstr.1; D-91301 Forchheim Phone: +49 9191 18-9355 Fax: +49 9191 18-9782

Date of Preparation of Summary: August 26th 2005 5.

510/k) submission for SIEMENC 'cunnon Nourn Don or a

{1}------------------------------------------------

SAFETY AND EFFECTIVENESS INFORMATION SUPPORTING THE SUBSTANTIAL ll. 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, and radiation hazards, Siemens adheres to recognized and established industry practice and standards.

7. Substantial Equivalence:

The syngo Neuro DSA CT 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	InSpace 4D	K043469	02/03/2005
2. Siemens	Leonardo	K040970	07/08/2004

Device Description and Intended Use: 8.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. Inside the circle is a stylized image of an eagle with three stripes across its body. The eagle is facing to the right.

NOV - 4 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Siemens AG % Stefan Preiss Responsible Third Party Official TUV America, Inc. 1775 Old Highway 8 NEW BRIGHTON MN 55112-1891

Re.: K053024

Trade/Device Name: Syngo Neuro DSA CT Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: October 13, 2005 Received: October 21, 2005

Dear Mr. Preiss:

We have reviewed vour 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.

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.

{3}------------------------------------------------

This letter will allow you to begin marketing your device as described in your Section 510(k) i ms letter will anow you to ogin maniening of substantial equivalence of your device to a legally premarket notheation: "The I DA miding or backannal or 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 If you desire specific advice for your device on our of the following numbers, based on the regulation number at the top of this letter:

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

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Also, please note the regulation entition, "Ribertation on your responsibilities under the Act from the 807.97). You may obtain other general informations of the many of its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Nancy C. Hogdon

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

Enclosure

{4}------------------------------------------------

SIEMENS

Indications for use

Attachment 2

Indication for use

510(k) Number (if known):

K053024

syngo Neuro DSA CT Device Name:

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

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

Prescription Use		OR	Over-The-Counter Use
(Per 21 CFR §801.109)
	Carlyn Y Newland
	(Division Sign-Off)
	for Division of Reproductive, Abdominal, and Radiological Devices
510(k) Number	K053024

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.