The Advantage Windows Volume Rendering Option is intended to provide volume visualization of three dimensional structures imaged with computed tomography (CT), or magnetic resonance (MR). It reconstructs and displays translucent 3D models to be used for diagnosis confidence or planning surgical treatment. The images are reconstructed and displayed on the CT/MR Advantage Windows Diagnostic Workstation (K913770).

Device Description

The device is a soltware package to be used on the same software as used for Advantage Windows 3D (VoxTool) and will operate on the Advantage Windows Operating System. The workstation hardware required for operation will be the Sun Spar 20, Mod 40, or higher. The images used to provide these 3D reconstructions can be captured by any CT or MR system and transferred to Advantage Windows workstation by DICOM or Ethernet.

AI/ML Overview

The provided documents do not contain a study that proves the device meets specific acceptance criteria in terms of performance metrics.

Instead, this is a 510(k) submission for the "Advantage Windows Volume Rendering Option" which focuses on demonstrating substantial equivalence to already marketed devices. The document highlights the device's intended use, description, and states its substantial equivalence in design, construction, principle of operation, and features to the predicate devices.

Therefore, many of the requested details about acceptance criteria, detailed performance studies, sample sizes, and ground truth establishment are not present in this type of regulatory submission. The goal of this submission is not to prove specific performance metrics against pre-defined acceptance criteria, but rather to show that the new device is as safe and effective as a legally marketed predicate device.

Here's a breakdown of what can be extracted or inferred from the provided information, and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Safety	No adverse affects on health reported. Package itself will not have any adverse effects.
Effectiveness	Enhances current Advantage Windows 3D package by providing depth and position of overlapping structures.
Intended Use	Provides fast, easy volume visualization of 3D structures from CT/MR. Dedicated to clinical and diagnostic applications in radiology, surgery, and treatment planning. Reconstructs and displays translucent 3D models for diagnosis confidence or planning surgical treatment.
Substantial Equivalence	Substantially equivalent to Advantage Windows 3D (K923077), Advantage Windows 3D with Navigator Option (K954355), and Advantage CT (9800 Quick) 3D (K871859) in design, construction, principle of operation, and features.

Missing:

Specific quantitative performance metrics (e.g., accuracy, sensitivity, specificity, processing speed targets, image quality ratings) are not provided.
Clearly defined numerical acceptance criteria for any performance aspect are not stated.

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

Missing: The document does not describe a formal "test set" or specific study involving patient data to evaluate the performance of this device. The assessment is based on substantial equivalence to existing devices.

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

Missing: As there's no described performance study or test set, there is no information on experts establishing ground truth.

4. Adjudication method for the test set

Missing: 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

Missing: No MRMC study is mentioned. This device is a volume rendering tool, not an AI-assisted diagnostic tool in the modern sense that would typically involve a "human readers improve with AI vs without AI" comparison.

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

Missing: No standalone performance study based on specific metrics is described. The device's function is to reconstruct and display models for operator interpretation, inherently involving a human-in-the-loop.

7. The type of ground truth used

Missing: No specific ground truth methodology is described as there isn't a performance study evaluating diagnostic accuracy.

8. The sample size for the training set

Missing: This device predates the widespread use of large-scale machine learning and deep learning models that typically require large "training sets." The device's functionality appears to be based on established algorithms for volume rendering, not a learned model from a training set in the contemporary sense.

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

Missing: Not applicable, as there's no indication of a training set for a machine learning model.

Summary of the Study (or lack thereof, in the typical sense):

The provided information is a 510(k) summary for an accessory device (software) for CT/MR systems. The "study" described herein is the process of demonstrating substantial equivalence to predicate devices already on the market. This involves:

Identification of Predicate Devices: Advantage Windows 3D (K923077), Advantage Windows 3D with Navigator Option (K954355), and Advantage CT (9800 Quick) 3D (K871859).
Comparison of Device Features and Principles of Operation: The submitter argues that the new Volume Rendering Option "enhances the current Advantage Windows 3D package by providing showing depth and position of overlapping structures" but is "substantially equivalent... in design, construction, principle of operation, and features."
Assessment of Safety: The document states that "The package itself will not have any adverse affects on health."
Intended Use Statement: Clearly defines how the device is to be used.

The FDA's letter (K972399) confirms that they have reviewed the submission and determined that the device is substantially equivalent to predicate devices for the stated indications for use. This regulatory pathway does not typically require extensive clinical performance studies or a detailed breakdown of acceptance criteria and performance data as would be seen for devices seeking a PMA or those involving novel AI algorithms.

Summary

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9723999

SEP 2 3 1997

GE Medical Systems

Summary of Safety & Effectiveness

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

Identification of Submitter.

Larry A. Kroger, Ph.D. (414) 544-3894 Summary prepared 24 June 1997

Product Identification:

Name: Advantage Windows Volume Rendering Option General Electric Medical Systems Manufacturer. 16800 W. Ryerson Road New Berlin, WI 53151

Marketed Devices: The Advantage Windows Valume Rendering Option is substantially equivalent to the currently marketed Advantage Windows 3D (K923077), Advantage Windows 3D with Navigator Option (K954355), and Advantage CT (9800 Quick) 3D (K871859)

Indications for Use Advantage Windows Volume Rendering Option is intended to provide fast, easy volume visualization of three dimensional structures imaged with a computed tomography (CT) or magnetic resoriance (MR) system. It is dedicated to clinical and disgnostic applications in radiology, surgery, and treatment planning. It runs on Advantage Windows independent workstations

Device Description: Design: The device is a soltware package to be used on the same software as used for Advantage Windows 3D (VoxTool) and will operate on the Advantage Windows Operating System. The workstation hardware required for operation will be the Sun Spar 20, Mod 40, or higher. The images used to provide these 3D reconstructions can be captured by any CT or MR system and transferred to Advantage Windows workstation by DICOM or Ethernet.

Energy Source and Exposure Levels: There is no energy source associated with this package in and of itself. However, the energy source used to make the image being analyzed is the same used to take standard CT or MR diagnostic images.

Principals of Operation: The same as Advantage Windows 3D. Features: To provide translucent 3D models of areas of interest selected by the operator. Accessories: None

Adverse fifteds on Health: The package itself will not have any adverse affects on health. This woll reconstructs and displays a translucent 3D model of a region of interest selected by the operator. The selection of the region of interest is up to the operator who can choose to accept or reject the region selected.

Conclusions: The Advantage Windows Volume Rendering Option enbances the current Advantage Windows 3D package by providing showing depth and position of overlapping structures. It is substantially equivalent to the Advantage Windows 3D package in design, construction, principle of operation, and features.

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Image /page/1/Picture/2 description: The image shows a logo for the Department of Health. The logo features the words "DEPARTMENT OF HEALTH &" in a vertical orientation on the left side of the image. To the right of the text is a symbol consisting of three stylized, curved lines that resemble a human figure or abstract design. The logo is printed in black ink on a white background.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 3 1997

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

Re: K972399

Advantage Windows Volume Rendering Option (CT/MR Accessory) Dated: June 24, 1997 Received: June 26, 1997 Regulatory Class: II 21 CFR 892.1750/Procode: 90 JAK 21 CFR 892.1000/Procode: 90 LNH

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 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 (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 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 prediction 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 yitto diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for question 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,

h.7.liau Yu
Lillian Yiu, Ph.D.

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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510(k) Number (if known):

Advantage Windows Volume Rendering Option Device Name:

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)

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

510(k) Number	K972399
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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.