The Advantage 3D XR is an X-ray imaging software option that offers the ability to construct a 3D model from images taken during a single DSA rotational angiography. The product is optimized for neuro-angiographic cases.

Device Description

The Advantage 3D XR is an X-ray imaging software option that allows the interactive display of a structure from any point of view. This is accomplished by constructing a 3D model from images taken during a single Digital Subtracted Angiography (DSA) rotation (200 degrees). A spin acquisition is performed with an LC gantry system using a specific mode (predefined start and stop positions). The data is available for diagnosis on the acquisition system and may be sent to the Advantage Windows workstation. Within 10 minutes, a 3D construction of the vasculature is available and the Navigator software package (K954355) is used to interactively create views of this object. The software allows the ability to make measurements ( length and volume) on the 3D structure. The gantry angles for each view are displayed and the physician may use them to make a DSA acquisition on the patient to get an optimized 2d image of the desired viewpoint.

AI/ML Overview

Here's an analysis of the provided text to extract information about the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state quantitative acceptance criteria (e.g., minimum accuracy, sensitivity, or specificity thresholds). Instead, the performance is described through the successful validation and clinical use, implying that the device generates "3D information from an X-ray spin sequence" and that "the 3D construction of the vasculature is available" for diagnosis and measurement. The primary acceptance criterion seems to be the successful demonstration of the device's ability to perform its stated function and the absence of identified hazards that are not controlled by a risk management plan.

Acceptance Criteria (Implied)	Reported Device Performance
Ability to construct a 3D model from DSA rotational angiography images.	"Within 10 minutes, a 3D construction of the vasculature is available." The device successfully generates "3D information from an X-ray spin sequence."
Availability of interactive display and views of the 3D object.	"The Navigator software package (K954355) is used to interactively create views of this object."
Ability to make measurements (length and volume) on the 3D structure.	"The software allows the ability to make measurements (length and volume) on the 3D structure."
Control of potential hazards (wrong measurements, misdiagnosis).	Potential hazards are "controlled by a risk management plan including: a Hazard Analysis, a Software Development and Validation Process, and external validations of the algorithms by different research hospitals to assess the validity of the 3D information."
Optimized for neuro-angiographic cases.	"The product is optimized for neuro-angiographic cases."
Substantial equivalence to predicate device (Advantage Windows 3D with Navigator Option).	FDA determined the device is "substantially equivalent" to the predicate for the stated indications for use.

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

The document mentions two types of clinical sites and examinations:

Morphometer Sites: More than 200 examinations were done using a morphometer device at Hopital Ponchaillou, Rennes, France and HCL, Lyon, France.
LC Angiographic System Gantry Sites: 250 examinations were performed at Hopital Pontchaillou, Rennes, France and CHU Saint-Julien, France.

Combining these, a total of over 450 examinations were performed for the clinical validation.

Data Provenance: The data is prospective clinical data collected from two countries: France (Hopital Ponchaillou, Rennes; HCL, Lyon; CHU Saint-Julien).

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

The document states "external validations of the algorithms by different research hospitals to assess the validity of the 3D information." It also mentions "A publication from Pr Picard, CHU Saint-Julien, France is available." and "medical publications on the obtained results are available in Attachment #9."

However, the document does not specify the exact number of experts used to establish ground truth for the test set, nor their specific qualifications (e.g., "radiologist with 10 years of experience"). It only implies involvement of medical professionals at the research hospitals.

4. Adjudication Method for the Test Set:

The document does not explicitly describe an adjudication method (e.g., 2+1, 3+1). It only refers to "external validations" and "medical publications."

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size:

The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance. The focus is on the standalone performance and capabilities of the 3D reconstruction software itself.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Yes, the studies described are essentially standalone performance evaluations of the algorithm. The "successful validation" using morphometer and LC angiographic system gantry, producing 3D constructions and measurements, describes the algorithm's direct output. The statement "Within 10 minutes, a 3D construction of the vasculature is available" and the ability to make measurements directly reflect the algorithm's standalone capability.

7. The Type of Ground Truth Used:

The document implies a form of expert consensus and clinical assessment as the ground truth. The "external validations of the algorithms by different research hospitals to assess the validity of the 3D information" and the "medical publications on the obtained results" suggest that the output of the 3D reconstruction was clinically reviewed and found to be valid and useful by medical experts in determining patient anatomy. It's not explicitly stated as pathology or outcomes data in this summary.

8. The Sample Size for the Training Set:

The document does not specify the sample size used for the training set. The described studies focus on the validation of the device.

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

The document does not provide information on how the ground truth for the training set was established. This detail is typically part of development and internal validation, which is not detailed in this summary of safety and effectiveness.

Summary

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

Image /page/0/Picture/0 description: The image shows a black and white logo of General Electric (GE). The logo consists of the letters 'g' and 'e' intertwined within a circular shape. The circle has a decorative border with small, rounded elements around its perimeter.

JUL 6 1998 GE Medical Systems

P.O. Box 414, W-709 Milwaukee, WI 53201 USA

ADVANTAGE 3D XR SUMMARY OF SAFETY AND EFFECTIVENESS

This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR Part 807.87(h)

Identification of Submitter:

Larry A. Kroger, Ph.D. Senior Manager of Regulatory Programs Telephone: (414) 544-3894 Date Prepared: December 5, 1997

Identification of Product:

Name :	Advantage 3D XR
Manufacturer :	General Electric Medical Systems
	283, rue de la Miniere
	78533 Buc Cedex, FRANCE
Distributor :	General Electric Medical Systems, Milwaukee, WI

Marketed Devices:

The Advantage 3D XR is substantially equivalent to the device listed below:

Model:	Advantage Windows 3D with Navigator Option
Manufacturer:	General Electric Medical Systems
510(k) #:	K954355

Device Description:

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

GE Medical Systems

P.O. Box 414, W-709 Milwaukee, WI 53201 USA

Indications for Use :

Comparison with Predicate:

The Advantage 3D XR option allows 3D construction of X-ray images similar to 3D images created with CT/MR images.

Summary of studies :

The Advantage 3D XR option has been successfully validated :

· using a device called a morphometer that consists of an X-ray tube mounted on a CT gantry to acquire views at multiple angles. Two morphometer's have been built and installed on two clinical sites: Hopital Ponchaillou, Rennes, France and HCL, Lyon, France. More than 200 examinations have been done and medical publications on the obtained results are available in Attachment #9.
using an LC angiographic system gantry. Two experimental clinical sites: Hopital pontchaillou, Rennes, France and CHU Saint-Julien, France have been running for a year and have performed 250 examinations. A publication from Pr Picard, CHU Saint-Julien, France is available in Attachment #9.

Conclusions :

The Advantage 3D XR option provides 3D information from an X-ray spin sequence. The potential hazards (wrong measurements, misdiagnosis) are controlled by a risk management plan including :

a Hazard Analysis
a Software Development and Validation Process .
· external validations of the algorithms by different research hospitals to assess the validity of the 3D information.

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

Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

6 1998 JUL

Larry A. Kroger, Ph.D. Senior, Regulatory Program Manager GE Medical Systems P.O. Box 414 Milwaukee. WI 53201

Re:

K974715

Advantage 3D XR (3D Image Processing Software) Dated: June 6, 1998 Received: June 17, 1998 Regulatory class: II 21 CFR 892.1750/Procode: 90 JAK

Dear Dr. Kroger:

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, 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 (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 (OS) 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/odrh/dsmaldsmamain.html".

Sincerely yours,

Kilian Yi

Lillian Yin, Ph.D. Director, Division of Reproductive Abdominal, Ear, Nose and Throa and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

510(k) Number (if known):

Device Name: Advantage 3D XR

Indications for Use

(PLESE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use _ X (Per 21 CFR 801-109)

OR Over-The-Counter Use_

David G. Seymore
Division Sign Off

Division Sign-Off) Division of Reproductive, Abdominal, E. and Radiological Dev 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.