Advantage 4D is a non-invasive software / hardware option that can be used to provide and display CT images of all phases of a breathing cycle for the evaluation of respiration-induced motion. The software will allow the user to retrospectively define the best respiratory phase from an image quality standpoint, and group images by the phase selected. Advantage 4D can also be used for target or treatment volume (DICOM Radiation Therapy Structure Sets) verification

Device Description

Advantage 4D enables a patient to be scanned on a CT with normal breathing. CT data are acquired and images are reconstructed without image artifacts due to organ and tissue motion. CT Images are synchronized with respiratory signal coming from external device and organ/tissue motion within the CT data reflecting both the organ motions and the chest motion. The user can then visually determine the optimum phase to perform volume imaging and post processing [quantification, contouring, segmentation. The respiratory phase identification is also provided. In addition. Advantage 4D has the capability to display DICOM Radiation Therapy Structure Sets and can be used for target or treatment volume verification.

AI/ML Overview

The provided text is a 510(k) summary for the GE Advantage 4D option, a software/hardware accessory for CT systems. It focuses on the device's technological equivalence to previously cleared devices rather than providing a detailed study that proves the device meets specific acceptance criteria.

Therefore, many of the requested details cannot be extracted from the provided document.

Here's a breakdown of what can be inferred or explicitly stated:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in terms of quantitative performance metrics for the Advantage 4D option. Instead, it relies on demonstrating substantial equivalence to predicate devices (Smart Breath Respiratory Compensation and Advantage Sim 6.0) based on similar technology, intended use, and absence of new safety risks.

Acceptance Criteria (Implied)	Reported Device Performance (Implied)
Similar Technology	Uses similar technology to Smart Breath Respiratory Compensation (K022919) and Advantage Sim 6.0 (K021780).
Similar Intended Use	Provides and displays CT images of all phases of a breathing cycle for respiration-induced motion evaluation; allows retrospective definition of best respiratory phase; groups images by selected phase; can be used for target/treatment volume verification.
No New Safety Risks	"Advantage 4D Option does not result in any new potential safety risks."
Performance as well as market devices	"performs as well as devices currently on the market."

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

Not specified. The document does not describe a test set or clinical study with patient data. The evaluation is based on technological comparison and risk analysis.

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

Not specified. No ground truth establishment processes involving experts are described for a test set.

4. Adjudication method for the test set

Not specified. No test set or adjudication method is described.

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. An MRMC study is not mentioned as this device is an accessory for displaying CT images synchronized with respiratory signals and does not involve AI assistance for human readers in the diagnostic process beyond presenting organized data.

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

The device is described as a "software / hardware option" that enables users to "visually determine the optimum phase" and "group images by the phase selected." While it processes data automatically to present phases, its primary function involves user interaction and interpretation of the displayed information. A standalone performance evaluation in the absence of human interaction is not described.

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

Not specified. Given the nature of the submission (510(k) for an accessory based on substantial equivalence), detailed clinical ground truth establishment for a diagnostic output is not the focus.

8. The sample size for the training set

Not specified. The document does not describe a training set as it's not a machine learning-based device requiring extensive training data.

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

Not applicable, as no training set is described.

Summary

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GE Medical Systems 3000 N. Grandview Blvd Waukesha, WI 53188

510(k) 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).

Larry A. Kroger, Ph.D. Submitter Senior Regulatory Program Manager Telephone: (262) 544-3894, FAX: (262) 548-4768 Date Prepared: August 8, 2002

PRODUCT IDENTIFICATION

Name:	Advantage 4D option
Classification Name:	Accessory to Computed Tomography System
Classification Panel	892 - Radiology
ClassificationNumber:	892.1750
Manufacturer :	GE Medical Systems3000 N. Grandview BlvdWaukesha, WI 53188, USA
Distributor:	General Electric Medical Systems, Milwaukee, WI
Marketed Devices:	Option is substantially equivalent to:Model: Smart Breath Respiratory CompensationManufacturer: General Electric Medical Systems510(k) #: K022919Option also incorporates features derived from:Model: Advantage Sim 6.0.Manufacturer: General Electric Medical Systems510(k) #: K021780

Device Description:

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K032915
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K∅32915

GE Medical Systems 3000 N. Grandview Blvd Waukesha, WI 53188

The user can then visually determine the optimum phase to perform volume imaging and post processing [quantification, contouring, segmentation. The respiratory phase identification is also provided.

In addition. Advantage 4D has the capability to display DICOM Radiation Therapy Structure Sets and can be used for target or treatment volume verification. This new capability comes from features derived from Advantage Sim 6.0 (K021780).

Indications for Use:

Comparison with Predicate:

This device will use a similar technology to that already used by GE Medical Systems in our cleared devices Smart Breath Respiratory Compensation (K022919) and Advantage Sim 6.0 (K021780). Fundamentally, this device will use the same phase selection process that is used in Smart Breath Respiratory Compensation to group images based on respiratory phase. In addition, Advantage 4D will have the ability to display reformat images through a Cine Phase Movie, and to overlay RTSS (Radiotherapy Structure Sets) contours over multiphase CT slices. These additional features are inherited from the viewer of Advantage Sim 6.0 (K021780). A more detailed comparison is included in Attachment C of this submission.

Device Name	FDA Clearance Number
Smart Breath Respiratory Compensation	K022919
Advantage Sim 6.0	K021780

Adverse Effects on Health :

The potential hazards are identified in a risk management summary (hazard analysis) and are controlled by:

· Software Development, Validation and Verification Process to ensure performance to specifications, Federal Regulations and user requirements.
· Adherence to industry and international standards.

Conclusions:

Advantage 4D Option does not result in any new potential safety risks and performs as well as devices currently on the market. GE considers features and technology of the Advantage 4D Option to be equivalent to those of Smart Breath Respiratory Compensation []K022919 and Advantage Sim 6.0 [K021780.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 3 0 2003

GE Medical Systems % Mr. Juergen Welte Responsible Third Party TUV Rheinland of North America 12 Commerce Road NEWTOWN CT 06470

Re: K032915

Trade/Device Name: Advantage 4D Option Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: 90 JAK Dated: October 14, 2003 Received: October 15, 2003

Dear Mr. Welte:

We have reviewed your 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 (PMA), 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.

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This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:

8xx. 1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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 vours.

Nancy C. Brogdon

Nancv 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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GE Medical Systems 3000 N. Grandview Blvd Waukesha, W1 53188

STATEMENT OF INTENDED USE

510(k) Number (if known): Ka32915

Device Name: Advantage 4D

Indications For Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use	✓
(Per 21 CFR 801.109)

-OR-

Over-The-Counter Use
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(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
K032915
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.