The 3D-Angio package is a x-ray imaging software option which allows the reconstruction of two-dimensional images acquired with a standard angiographic C-arm device into a three-dimensional image format. The 3D-Angio package is intended to assist the physician in diagnosis and treatment of vessel malformations (i.e. aneurysms, AVMs, stenoses), particularly neuro-angiographic cases.

Device Description

AI/ML Overview

This 510(k) summary for the 3D-Angio software option provides very limited information regarding acceptance criteria and performance studies. The document primarily focuses on establishing substantial equivalence to a predicate device based on its technological characteristics and intended use. Therefore, much of the requested information cannot be extracted from the provided text.

Here's an attempt to answer the questions based on the available information:

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

No explicit acceptance criteria are mentioned in the provided text. The document states that the 3D-Angio software is "substantially equivalent" to the GE Advantage 3D XR, implying that its performance is comparable to that device. However, no specific performance metrics or acceptance criteria for the 3D-Angio itself are presented.

Acceptance Criteria	Reported Device Performance
No explicit criteria provided in the document.	The device "allows construction of a three-dimensional model from images acquired during rotational angiography," which is stated as being comparable to the predicate device. No quantitative performance metrics are given.

2. Sample size used for the test set and the data provenance

Not mentioned in the document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not mentioned in the document.

4. Adjudication method for the test set

Not mentioned in the document.

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 mentioned in the document. This submission predates the commonality of "AI" as understood today, and the focus is on a software option for 3D reconstruction, not an AI-powered diagnostic tool in the modern sense.

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

The entire device is a "software option," which inherently means it's an algorithm. However, the performance is described in terms of its ability to "assist the physician" implying human interpretation remains central. No specific standalone performance study without human interaction is detailed as an independent evaluation. The performance is implied through its intended use and comparison to a predicate device.

7. The type of ground truth used

Not mentioned in the document. Given the nature of a 3D reconstruction tool, the "ground truth" would likely relate to the accuracy of the 3D model relative to the actual anatomical structures, but no details are provided on how this was assessed.

8. The sample size for the training set

Not mentioned in the document.

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

Not mentioned in the document.

Summary

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K984634

510(K) SUMMARY FOR THE 3D-ANGIO SOFTWARE OPTION

Submitted by:

Siemens Medical Systems, Inc. 186 Wood Avenue South Iselin, NJ 08830

December 28, 1998

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

1. Contact Person:
  Ms. Malgorzata Stanek Phone: (732) 321-3950 Fax: (732) 321-4841

2. Device Name and Classification:

Trade Name: Classification Name: Classification Panel: CFR Section: Device Class: Product Code:

3D-Angio Accessory to Angiographic X-Ray System Radiology 21 CFR §892.1600 Class I.I. 90JAA

3. Substantial Equivalence:

The 3D-Angio software option is designed for three-dimensional evaluation of data acquired with a standard angiographic C-arm devices. The package is substantially equivalent to the following device:

Siemens Device Name	FDA Clearance Number	FDA Clearance Date
GE Advantage 3D XR	K974715	7/6/98

4. Device Description:

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Intended Use of the Device: 5.

The resulting images of the 3D-Angio package are intended to assist the physician in diagnosis and treatment of vessel malformations (i.e. aneurysms, AVMs, stenoses), particularly neuro-angiographic cases.

Summary of Technological Characteristics of the Devices Compared to the 6. Predicate:

Both the Siemens 3D-Angio software option and GE Advantage 3D XR allow construction of a three-dimensional model from images acquired during rotational angiography.

Kathleen Rutherford

Kathleen Rutherford Manager, Regulatory Submissions Siemens Medical Systems, Inc.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird in flight.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 2 1999

Malgorzata Stanek Technical Specialist Siemens Medical Systems, Inc. 186 Wood Ave. South Iselin, NJ 08830

Re:

K984634 3D-Angio (3D Angiographic Accessory) Dated: December 28, 1998 Received: December 30, 1998 Regulatory class: II 21 CFR 892.1600/Procode: 90 JAA

Dear Ms. Stanek:

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 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). 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 III (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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements; as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS 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 the Electronic Product 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/dsma/dsmamain.html".

Sincerely yours,

CARL T. HART, D.O., M.D.

CAPT Daniel G. Schultz. M.D. Acting 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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INDICATIONS FOR USE

510(k) Number (if known):	K984634
Device Name:	3D-Angio

Indications For Use:

The 3D-Angio package is intended to assist the physician in diagnosis and treatment of vessel malformations (i.e. aneurysms, AVMs, stenoses), particularly neuro-angiographic cases.

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

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

Yhind h. Lyan

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

Prescription Use ✗ OR Over-The-Counter Use __
(Per 21 CFR 801.109)

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.