syngo InSpace 4D - Software Package is a self-contained image analysis software package. This real-time interactive evaluation in space and time for CT volume data sets provides the reconstruction of two-dimensional images into a three-dimensional image format.

InSpace can be used to assist the physician in the diagnosis of blood vessels on the basis of a CT Angiography dataset (CTA). For a CTA examination a contrast media (CM) is administered into the patient's blood vessels to enhance the contrast of the vessels in the CTA dataset, i.e. high values for the Hounsfield Unit (HU).

The goal is to visualize the blood vessels without other interfering anatomical structures.

The syngo InSpace 4D is developed to facilitate a precise diagnosis by removing bone structures from a CTA data set. It can be used in the same way for Non CTA datasets to remove bones or extract and display selected bones, e.g. for the analysis of a fracture.

Device Description

syngo InSpace 4D- Software Package is a self-contained image analysis software oying mopular and time interactive evaluation in space and time for CT volume data patenager This he reconstruction of two-dimensional images into a three-dimensional image format.

InSpace can be used for the diagnosis of blood vessels on the basis of a CT Angiography dataset (CTA). For a CTA examination a contrast media (CM) is administered into the patient's blood vessels to enhance the contrast of the vessels in the CTA dataset, i.e. high values for the Hounsfield Unit (HU).

The goal is to visualize the blood vessels without other interfering anatomical structures.

The syngo InSpace 4D is developed to facilitate a precise diagnosis by removing bone structures from a CTA data set. It can also be used to extract and display selected bones, e.g. for the analysis of a fracture.

AI/ML Overview

The provided text lacks specific information regarding acceptance criteria and a detailed study report proving the device meets those criteria. The 510(k) summary focuses on establishing substantial equivalence to a predicate device (InSpace 3D) rather than presenting a performance study with defined acceptance metrics.

Therefore, most of the requested information cannot be extracted from the given document.

Here's what can be gathered, with limitations noted:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria: Not explicitly stated in terms of specific performance metrics (e.g., sensitivity, specificity, accuracy, processing time). The document implies that the acceptance criteria are met by demonstrating "substantial equivalence" to the predicate device and adhering to general safety and effectiveness concerns through hazard analysis, software development, verification, and validation testing.
Reported Device Performance: Not reported in terms of quantifiable metrics. The document states that the "syngo InSpace 4D Software Package does not introduce any new potential safety risks and is substantially equivalent to and performs as well as the predicate software components and the predicate device." This is a qualitative statement of equivalence, not a quantitative performance report against specific criteria.

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

Sample Size for Test Set: Not specified.
Data Provenance: Not specified.

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 specified. The document does not describe the methodology for establishing ground truth or the involvement of experts in any testing.

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

Not specified. No details on test set evaluation or adjudication are provided.

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 MRMC comparative effectiveness study is mentioned or described. The document primarily focuses on the device's functionality (bone removal for CTA data) and its substantial equivalence to a previous version, not on assessing human reader performance with or without the device.

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

No standalone performance study with specific metrics is described. The device is referred to as "intended to assist the physician," implying a human-in-the-loop context. However, no performance data is provided for either standalone or assisted use.

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

Not specified. The document does not detail how the accuracy of bone removal or vessel visualization was assessed or what method was used to establish ground truth for any testing conducted.

8. The sample size for the training set

Not specified. The document does not mention any "training set" or machine learning aspects that would typically involve such a set. The device is described as "image analysis software" but does not indicate the use of AI/ML models that would require training data in the modern sense.

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

Not applicable, as no training set or related ground truth establishment is mentioned.

Summary of available information:

The provided 510(k) summary focuses on demonstrating the substantial equivalence of the "syngo InSpace 4D" software package to its predicate device, "InSpace 3D," primarily based on its functionality without introducing new safety risks. It highlights the device's purpose: real-time interactive evaluation of CT volume data, reconstruction into 3D format, and specifically, the ability to remove bone structures from CTA datasets (and non-CTA datasets) to facilitate precise diagnosis of blood vessels or analysis of fractures.

The document does not contain the detailed performance study information, acceptance criteria, sample sizes, ground truth methodologies, or expert involvement details typically found in submissions for novel devices or those requiring a comprehensive effectiveness study. This is common for 510(k) submissions that rely heavily on substantial equivalence to a previously cleared device, where extensive new performance data may not be required to establish equivalence for a modification or updated version.

Summary

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FEB - 3 2005

SECTION 9

510(k)

K04 3469
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: InSpace 4D

Classification Name: Accessory to Computed Angiographic x-ray system Classification Panel: Radiology CFR Section: 21 CFR §892.1600 Device Class: Class II Product Code: IZI

Importer/Distributor Establishment: 2.

Registration Number: 2240869

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

3. Manufacturing Facility:

Siemens AG Wittelsbacherplatz 2 D-80333 Muenchen, Germany

4. Contact Person:

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

Date of Preparation of Summary: October 15th, 2004 5.

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II. SAFETY AND EFFECTIVENESS INFORMATION SUPPORTING THE SUBSTANTIAL EQUIVALENCE DETERMINATION

1. General Safety and Effectiveness Concerns

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.

2. Substantial Equivalence

The syngo InSpace 4D Software Package, addressed in this pre-market notification, is substantially equivalent to the following commercially available software package:

Manufacturer	Product	510(k)	Clearance date
Siemens	InSpace 3D	K011447	Aug. 03, 2001
( Remark:	The current trade name of this software package is InSpace4D. This modificationrefers to the temporal dependence and has been separately documented.)

In summary, Siemens is of the opinion that syngo InSpace 4D Software Package does not introduce any new potential safety risks and is substantially equivalent to and performs as well as the predicate software components and the predicate device.

3. Intended Use

The syngo InSpace 4D software package is intended to assist the physician in skeletal and soft tissue imaging in addition to the originally approved indications.

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4. Device Description

The goal is to visualize the blood vessels without other interfering anatomical structures.

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Image /page/3/Picture/10 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three stripes forming its wing and three wavy lines below, representing water. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Siemens AG, Medical Solutions % Mr. Stefan Preiss Responsible Third Party Official TÜV Product Service 1775 Old Highway 8 NEW BRIGHTON MN 55112-2487 Re: K043469 Trade/Device Name: "In Space 4D" with Bone Removal Feature Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: 90 JAK Dated: January 13, 2005 Received: January 19, 2005

Dear Mr. Preiss:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced we have levewed your beatler ovee is substantially equivalent (for the indications for use stated in above and have acterining arketed predicate devices marketed in interstate commerce prior to the cholosate) to regary mannent date of the Medical Device Amendments, or to devices that have been May 20, 1770, the enavinentificans of the Federal Food, Drug, and Cosmetic Act (Act) that recrassmed in accordantes werematket approval application (PMA). You may, therefore, market the do not require approval or a provisions of the Act. The general controls provisions of the Act ucvice, subject to the general version, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

FEB - 3 2005

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket If your de rece is olassines (see as hadditional controls. Existing major regulations affecting your Apploval), It may of babyer to on Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA device ban of round mouncements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that I lease be advisod that 127 i our device complies with other requirements of the Act or any FDA has made a actorninations administered by other Federal agencies. You must comply with all the I cacal statues and rogaldirent and 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) (21 CFR Part 80 77, government 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 Section 510(k) I his letter will anow you to oegh manieting of substantial equivalence of your device to a legally premarket nothication. The I DA midnig of backannal veryour 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 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 entired, " Execution on your responsibilities under the Act from the 807.97). Tou may obtain other general and Consumer Assistance at its toll-free number (800) DIVISION of Sillan Manufacturers, Internet address http://www.fda.gov/cdrb/dsmaldsmamain.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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510(k)

SECTION 3

INDICATION FOR USE

510(k) Number (if known): K043469

Device Name: InSpace 4D

Indications for Use:

The goal is to visualize the blood vessels without other interfering anatomical structures.

Prescription Use (Part 21 CFR 801 Subpart D)

ANDIOR

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)

Daniel Kr. Glynn

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

510(k) submission for SIEMENS ' InSpace 4D'

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.