3D presentation of the couplete anatomic structure (i.e. head, chest, abdomen) covered by the original CT or MR images for diagnosis and use in treatment planning;
diagnosing as well as treatment planning from real time Multi-Planar-Reconstruction (MPR):the Realtime 3D tool can help the user to position and visualize the 3-dimensional location of the MPR within the 3D volume by using interactive clip planes in real time;
CTA and MRA displaying cohanced vessels;
measurement of analomical structures in the 3D volume. Important for quantitative measurement of geometry and length of anatomy indices;
displaying the position of anatomical structures in relationship to each other;
navigating interactively through anatomical structures (e.g., vessels, colon, spine, lung, etc.) or inside the 3D volume;
depth perception using the Stereo display option to visualize i.e. overlaying and underlying vessels:
for viewing the inner surface of organs (vessels, colon, etc.);

Device Description

Realtime 3D (RT3D) Diagnostic Workstation includes all the necessary hardware and software components for a medical imaging workstation that allows 3D visualization of tomographic dataset from either a CT or MR scanner together with Multiplanar Reconstructions (MPR), and allows the user to fly through or around the 3D image(s) in real time. The user can also view the 3D images in stereo and make measurements in the 3D images.

AI/ML Overview

The Siemens Realtime 3D Software Package is a medical imaging workstation designed for 3D visualization of tomographic datasets from CT or MR scanners, offering Multiplanar Reconstructions (MPR), real-time "fly-through" capabilities, stereo display, and 3D measurements. It is intended to provide physicians with additional diagnostic information, assist in pre-surgical and post-surgical evaluations, and improve patient care through fast case-turnaround times.

The 510(k) summary provided does not explicitly define specific quantitative acceptance criteria or a detailed clinical study with performance metrics for the Siemens Realtime 3D Software Package. Instead, the submission focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and intended use.

1. Table of Acceptance Criteria and Reported Device Performance

As the document does not specify quantitative acceptance criteria or detailed performance metrics, a table cannot be populated in the traditional sense. The equivalence is stated based on functional similarities.

Acceptance Criteria (Implied)	Reported Device Performance
3D Rendering and Visualization: Ability to display tomographic datasets in 3D space, showing spatial relationships.	The device provides 3D visualization of tomographic datasets from CT or MR, allowing users to "fly through or around" 3D images in real time and view them in stereo.
Multiplanar Reconstructions (MPR): Provision of MPR functionality.	The device offers MPR, with an added feature of interactive clip planes for real-time MPR.
Navigation Tools: Ability to navigate through anatomical structures.	Provides a "navigation tool that can be used to 'Fly around' or 'Fly through' the anatomy of interest."
3D Measurement: Capability to make measurements in 3D images.	Offers 3D measurement capabilities for anatomical structures.
Real-time Performance: Fast image processing and display.	"Due to its real time performance, Realtime 3D provides the user with fast case-turnaround time." "RT3D has the added ability to show 3D images in real time."
Substantial Equivalence to Predicate Devices: Similar technological characteristics and intended use as existing marketed devices.	Stated to have the "same technological characteristics as Vitrea™ 3D Medical Visualization System" and "MagicView Workstation," with additional features.

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

The provided 510(k) summary does not contain information regarding a specific test set, its sample size, or data provenance (e.g., country of origin, retrospective/prospective nature). The submission relies on a comparison of technological characteristics to predicate devices rather than a performance study on a specific dataset.

3. Number of Experts Used to Establish Ground Truth and Their Qualifications

The document does not mention the use of experts to establish ground truth for a test set, nor does it specify their number or qualifications. This type of information would typically be found in a clinical performance study, which is not detailed in this 510(k) submission.

4. Adjudication Method for the Test Set

As no specific test set or performance evaluation is described, there is no mention of an adjudication method for a test set.

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

An MRMC comparative effectiveness study was not discussed or presented in the provided 510(k) summary. The submission focuses on functional equivalence rather than comparative clinical performance with human readers. Therefore, an effect size comparing human readers with and without AI assistance is not available.

6. Standalone (Algorithm Only) Performance Study

A standalone performance study (i.e., algorithm only without human-in-the-loop performance) was not described or conducted as part of this 510(k) submission. The device is a workstation with software intended for physician use, and the evaluation presented is a comparison of its features to predicate devices.

7. Type of Ground Truth Used

The document does not specify a type of ground truth used, as it doesn't detail a performance study with a specific dataset. The evaluation is based on the functional and technical capabilities of the device compared to predicate devices.

8. Sample Size for the Training Set

The provided 510(k) summary does not contain information regarding a training set or its sample size. This type of information is typically relevant for machine learning-based algorithms, which are not explicitly detailed in the context of this device's functionality beyond standard 3D rendering and processing.

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

Since no training set is mentioned, the method for establishing its ground truth is also not discussed in the document.

Summary

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SIEMENS

ATTACHMENT 10

510(k) Summary

Siemens Realtime 3D Software Package

NOV 10 1997

August 8, 1997

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.

Establishment

• Address:	Siemens Medical Systems, Inc.186 Wood Avenue SouthIselin, NJ 08830
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Contact Person:	Kathleen M. RutherfordManager, Regulatory Submissions(908) 321-4779(908) 321-4841	phonefax
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Device Name

Trade Name: Realtime 3D Diagnostic Workstation .
Common Name: 3D CT/MR Post-processing Workstation .
. Classification Name: Picture Archiving and Communication System (PACS)
Classification: Class II
None established under Section 514 . Performance Standards: of the Food, Drug, and Cosmetic Act.

II. Information Supporting Substantial Equivalence Determination.

· Device Description:

• Intended Use:

The Realtime 3D application is intended to provide the physician with additional diagnostic information through displaying the

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SIEMENS

tomographic dataset in 3 dimensional space which can show the spatial relationship among different anatomical structures. It can also be used for pre-surgical and post-surgical evaluation by surgeons. Due to its real time performance, Realtime 3D provides the user with fast case-turnaround time which leads to improved patient care and cost savings.

· Technological Characteristics as compared to the Predicate Device:

The Realtime 3D has the same technological characteristics as Vitrea™ 3D Medical Visualization System. They both provide the user with 3D and MPR of anatomic structures. They both provide the user with a navigation tool that can be used to "Fly around" or "Fly through" the anatomy of interest. Siemens Realtime 3D offers, in addition, interactive clip planes which provides the user with real time MPR, stereo display, 3D measurement, and an orientation view during Fly-through and fly-around for better orientation and navigation.

The Realtime 3D has the same technological characteristics as the MagicView Workstation. They have substatially similar MPRs, MIPs, and volume rendering algorithm. RT3D has the added ability to show 3D images in real time.

· Substantial Equivalence:

Siemens Realtime 3D is substantially equivalent to the following devices:

Vitrea™ 3D Medical Visualization System . Vital Images
MagicView Diagnostic Workstation . Siemens Medical Systems, Inc.

Kathleen Rutherford

Kathleen Rutherford Manager, Regulatory Submissions Imaging Systems Group, Siemens Medical Systems

8/7/97
Date

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Re:

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 10 1997

Kathleen Rutherford Manager, Regulatory Submissions Siemens Medical Systems, Inc. 186 Wood Avenue South Iselin, NJ 08830

K973010 Realtime 3D Diagnostic Workstation Dated: August 8, 1997 Received: August 13, 1997 Regualtory class: Unclassified Procode: 90 LLZ

Dear Ms. Rutherford:

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 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). You may, therefore, 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 requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS 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 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/dsmamain.html".

Sincerely yours.

W.Liau Yu

Lillian Yin, Ph.D. 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 1(revision)

Indications For Use

973010 510(k) Number (if known): Realtime 3D Diagnostic Workstation Device Name:__________________________________________________________________________________________________________________________________________________________________

Indications For Use:

From user specified sets of CT or MR images, Realtime 3D can be used for

3D presentation of the couplete anatomic structure (i.e. head, chest, abdomen) covered by the . original CT or MR images for diagnosis and use in treatment planning;
diagnosing as well as treatment planning from real time Multi-Planar-Reconstruction (MPR):the . Realtime 3D tool can help the user to position and visualize the 3-dimensional location of the MPR within the 3D volume by using interactive clip planes in real time;
CTA and MRA displaying cohanced vessels; .
measurement of analomical structures in the 3D volume. Important for quantitative measurement of 9 geometry and length of anatomy indices;
displaying the position of anatomical structures in relationship to each other; .
navigating interactively through anatomical structures (e.g., vessels, colon, spine, lung, etc.) or . inside the 3D volume;
depth perception using the Stereo display option to visualize i.e. overlaying and underlying vessels: .
for viewing the inner surface of organs (vessels, colon, etc.); .

( please do no write below this line- continue on another page if needed )

Prescription Use
(Per 21 CFR 801.109)

Thind G. Seppmm

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devic 510(k) Number

Regulation Number and Section

§ 892.2050 Medical image management and processing system.

(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).