GE View Applications is a medical image viewing software device that allows a user to select, send, receive, and review DICOM images from modalities, such as computed tomography ("CT"), magnetic resonance ("MR"), x-ray ("XR"), nuclear medicine ("NM"), ultra sound ("US"), computed radiography ("CR"), and modalities that generate secondary capture ("SC") images. GE View Applications is intended to meet different application requirements ranging from simple medical image viewing on the physician's desktop to clinical image review (e.g., in the ICU).

Device Description

GE View Applications is medical image viewing software that consists of two products: the GE Viewing Station and the GE Extended Viewing Station. GE View Applications is a two-dimensional ("2D") review application software for a PC/WIN platform that allows a user to select, send, receive, display, and review of patient image data using the DICOM communication standard. DICOM images can be displayed from any of the following modalities: computed tomography ("CT"); magnetic resonance ("MR"); x-ray ("XR") (XA, R/F); nuclear medicine ("NM"); ultra sound ("US"); computed radiography ("CR"); and modalities that generate secondary capture ("SC") images. GE View Applications can be installed on a PC in the hospital on a local area network ("LAN") or wide area network ("WAN") and includes teleradiology, connectivity, and display features.

AI/ML Overview

The provided document, K991629 for GE View Applications, is a 510(k) summary for a medical image viewing software. Unfortunately, it does not contain the detailed performance data typically required to answer your specific questions about acceptance criteria and the comprehensive study that proves the device meets those criteria.

Here's an analysis based on the available information:

1. Table of acceptance criteria and the reported device performance:

The document states: "System design verification tests have been conducted to assure conformance with the design specifications. Validation testing will be conducted according to the validation test plan and procedures."

This indicates that acceptance criteria and performance data exist, but they are not provided in this 510(k) summary. The summary focuses on established substantial equivalence rather than presenting detailed performance metrics. Therefore, a table cannot be populated from the given text.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

No information is provided regarding the sample size of any test set, nor the data provenance (country of origin, retrospective/prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

No information is provided regarding the number or qualifications of experts used to establish ground truth for any test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

No information is provided regarding an adjudication method for a test set.

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:

A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or reported in this 510(k) summary. This device is described as "medical image viewing software" and its primary function is display and review, not an AI-powered diagnostic aid that would typically involve an MRMC study measuring reader improvement.

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

A standalone performance study was not reported in this 510(k) summary. The device is a "medical image viewing software" intended for human review, not an autonomous algorithm.

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

No information is provided regarding the type of ground truth used.

8. The sample size for the training set:

No information is provided regarding the sample size of a training set. This device is a viewing application, not an AI/ML algorithm that typically has a training set.

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

No information is provided regarding how ground truth for a training set was established.

Summary of what the document does tell us:

Device Type: Medical image viewing software (GE View Applications, including GE Viewing Station and GE Extended Viewing Station).
Functionality: Select, send, receive, display, and review patient image data using the DICOM communication standard from various modalities (CT, MR, XR, NM, US, CR, SC).
Intended Use: Simple medical image viewing on a physician's desktop to clinical image review (e.g., in the ICU).
Regulatory Pathway: 510(k) substantial equivalence.
Predicate Devices: GE Advantage Review Remote Workstation (K936179) and GE Advantage Windows Diagnostic Review Workstation (K960613).
Performance Data (General Statement): "System design verification tests have been conducted to assure conformance with the design specifications. Validation testing will be conducted according to the validation test plan and procedures."

Conclusion:

The provided 510(k) summary for GE View Applications (K991629) is a premarket notification for a medical image viewing software. As is common for many non-AI/ML devices cleared via the 510(k) pathway, it primarily establishes substantial equivalence to predicate devices and states that design verification and validation testing were, or will be, conducted. It does not contain the detailed clinical performance study data (acceptance criteria, sample sizes, ground truth establishment, expert qualifications, MRMC studies, standalone performance, etc.) that would be expected for a more complex diagnostic algorithm or an AI/ML-driven device. These details would typically be found in the full 510(k) submission, not necessarily in the publicly available summary.

Summary

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AUG - 2 - 2 - 39

510(k) SUMMARY FOR GE View Applications

K991629

I. System Sponsor
- Sponsor's Name and Address A.

Larry Kroger Environmental, Health & Safety GE Medical Systems P.O. Box 414 Milwaukee, WI 53201 Phone: (414) 544-3894 (414) 544-3863 Fax:

II. System Identification
- Classification Name A.

Image Processing System

Common/Usual Name B.
Medical Image Viewing Software
Trade/Proprietary Name of the System C.
GE View Applications (GE Viewing Stations and GE Extended Viewing Station)
Classification D.
Regulatory Class: II (two); 21 C.F.R. § 892.2050 Classification Panel: Radiology Product code: LLZ

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III. Predicate Device

General Electric Medical Systems - GE Advantage Review Remote Workstation, K936179. (Cleared as the WinRad Teleradiology System by Line Imaging Systems.)

General Electric Medical Systems - GE Advantage Windows Diagnostic Review Workstation, K960613.

IV. Device Description

V. Intended Use

GE View Applications allows a user to select, send, receive, and review DICOM images from modalities, such as CT, MR, XR, CR, and modalities that generate SC images. GE View Applications is intended to meet different application requirements ranging from simple medical image viewing on the physician's desktop, clinical image review (e.g., in the ICU).

VI. Substantial Equivalence Comparison

GE View Applications is a medical image viewing software device that is substantially equivalent to medical image viewing software devices previouslycleared and currently marketed by GE Medical Systems ("GEMS"). GE View Applications has the same intended use as GE Advantage Review Remote Workstation ("ARR") and the GE Advantage Windows Diagnostic Review Workstation ("AWDR"). GE View Applications is based on, and contains many of the features that were previously-cleared in GE ARR and three features that were previously-cleared in GE AWDR. This device contains one new feature, DICOM CD-Reader. GE View Applications' system requirements also resemble

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those in GE ARR and GE AWDR; however, the system has been upgraded to take advantage of currently technology (more memory, higher speed processor, etc.).

VII. Performance Data

System design verification tests have been conducted to assure conformance with the design specifications. Validation testing will be conducted according to the validation test plan and procedures.

VIII. Conclusions

GE View Applications is substantially equivalent to GEMS' previously-cleared GE ARR and GE AWDR Workstations.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG -. 2 1999

Larry A. Kroger, Ph.D. Senior Regulatory Programs Manager General Electric Medical Systems, Inc. P.O. Box 414 Milwaukee, Wisconsin 53201

Re:

K991629 GE View Applications (GE Viewing Station and GE Extended Viewing) Dated: May 7, 1999 Received: May 11, 1999 Regulatory Class: II 21 CFR 892.2050/Procode: 90 LLZ

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 legally marked 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 redassified 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 (Special Controls) or dass 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,

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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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: GE View Applications (GE Viewing Station and GE Extended Viewing Station)

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

David G. Seymon

(Division Sien-Off) Division of Reproductive, Abdominal, E and Radiologieni Dev 510(k) Number ,

Prescription Use __ (Per 21 CFR 801.109)

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

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).