4D View 9.1 is a standalone Software product, which can be installed only on a PC with Microsoft Windows Vista operating systems: Primary Operating Functions are: · Display and editing of GE Ultrasound 3D/4D data sets · Measurements on displayed image incl. derived calculations which are all based on medical literature in the following applications: Abdominal, Obstetrics, Gynecology, Cardiology, Urology, Vascular, Neurology, Small Parts, Pediatrics, Musculo-Skeletal (Orthopedics). · Data storage (image, measurement and patient data) · Data transfer to and from remote systems (e.g. via DICOM) · Adding annotations to acquired image Same measurements and calculations are available on the predicate devices

AI/ML Overview

Here's a summary of the acceptance criteria and study information for the GE Healthcare 4D-VIEW 9.1 device, based on the provided 510(k) summary:

The 4D-VIEW 9.1 device did not require clinical studies to support substantial equivalence. Therefore, there are no specific "acceptance criteria" or a "study that proves the device meets the acceptance criteria" in the traditional sense of a clinical performance study.

Instead, the submission focused on demonstrating substantial equivalence to predicate devices through non-clinical tests and technological similarity. The "acceptance criteria" are effectively that the device functions as intended, complies with voluntary standards, and has undergone appropriate quality assurance measures.

Here's the breakdown based on the provided documents:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Functional Capabilities:
- Display and editing of GE Ultrasound 3D/4D data sets	Primary Operating Function: Display and editing of GE Ultrasound 3D/4D data sets
- Measurements on displayed image (incl. derived calculations)	Primary Operating Function: Measurements on displayed image incl. derived calculations which are all based on medical literature in the following applications: Abdominal, Obstetrics, Gynecology, Cardiology, Urology, Vascular, Neurology, Small Parts, Pediatrics, Musculo-Skeletal (Orthopedics). Same measurements and calculations are available on the predicate devices.
- Data storage (image, measurement, patient data)	Primary Operating Function: Data storage (image, measurement and patient data)
- Data transfer to/from remote systems (e.g., via DICOM)	Primary Operating Function: Data transfer to and from remote systems (e.g. via DICOM)
- Adding annotations to acquired images	Primary Operating Function: Adding annotations to acquired image
Compliance with Standards:	The 4D VIEW 9.1 and its applications comply with voluntary standards as detailed in Section 9, 11 and 17 of this premarket submission.
Quality System Processes:	Quality assurance measures applied: Risk Analysis, Requirements Reviews, Design Reviews, Performance testing (Verification), Simulated use testing (Validation).
Substantial Equivalence to Predicate Device(s):	The device employs the same fundamental scientific technology as its predicate devices (Viewpoint 5.0 K050943 and Voluson E8 K061682). GE Healthcare considers the 4D-VIEW 9.1 to be as safe, as effective, and performance is substantially equivalent to the predicate device(s). The FDA's 510(k) clearance confirms this finding.
Operating System Compatibility:	Can be installed only on a PC with Microsoft Windows Vista operating systems.
Intended Use: (as per Indications for Use statement)	Image Display of GE Ultrasound 3D/4D ultrasound data sets for diagnostic purposes, including measurements on displayed image. The device's primary operating functions directly support this intended use by enabling display, editing, measurements, and data management of such data sets.

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

No specific clinical test set was used for a performance study. The submission states: "The subject of this premarket submission, 4D-View 9.1, did not require clinical studies to support substantial equivalence."
"Performance testing (Verification)" and "Simulated use testing (Validation)" were conducted as part of quality assurance measures, but details regarding sample size, data provenance, or specific methodologies for these internal tests are not provided in the 510(k) summary. These are typically internal engineering and V&V activities rather than formal clinical studies.

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)

Not applicable. As no clinical studies were required or conducted, there was no independent test set requiring expert ground truth establishment for a performance evaluation.

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

Not applicable. No clinical test set requiring adjudication was used.

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 MRMC comparative effectiveness study was done. The device 4D-VIEW 9.1 is a software product for viewing and measuring 3D/4D ultrasound data, not an AI-powered diagnostic tool for interpretation assistance in the context of comparative effectiveness studies against human readers.

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

Not explicitly described as a standalone performance study in the way this question is usually posed for AI algorithms. The device itself is described as "standalone Software product." Its performance is based on its ability to accurately display and calculate measurements from GE Ultrasound 3D/4D data. These functions are verified through internal performance testing and simulated use, much like any standard software. There isn't an "algorithm only" performance reported in the context of a diagnostic accuracy study.

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

No clinical ground truth (expert consensus, pathology, outcomes data) was used. The "ground truth" for the device's functions (e.g., measurement calculations, data display fidelity) would have been established internally through engineering specifications, known mathematical formulas, and comparison to outputs from the predicate devices or validated internal references during verification and validation testing.

8. The sample size for the training set

Not applicable. This device is a viewing and measurement software. It is not an AI/ML algorithm that requires a "training set" in the conventional sense. Its "knowledge" is embedded in its programming logic and algorithms derived from medical literature and engineering principles, rather than learned from a dataset.

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

Not applicable. As there is no training set, there is no ground truth establishment for a training set. The accuracy of its core functions (measurements, display) would be validated against established mathematical principles and reference standards during development and testing.

Summary

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K101166
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OCT 07 2010

510(k) Summary

In accordance with 21 CFR 807.92 the following summary of information is provided: Date: April 22, 2010 GE Healthcare, GE Medical Systems Ultrasound and Primary Submitter: Care Diagnostics, LLC. 9900 Innovation Drive 产品 Wauwatosa, WI, USA 53226 Primary Contact Person: Bryan Behn, Regulatory Affairs Manager GE Healthcare, GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC. Phone: 414-721-4214 Fax: 414-918-8275 Secondary Contact Person: Jim Turner Regulatory Affairs Manager GE Healthcare Phone: 262-544-3359 Fax: 414-908-9225 4D-VIEW 9.1 Device: Trade Name: Common/Usual Name: 4D-VIEW Classification Names: Class II CFR 892.2050, LLZ Picture Archiving and Communication Systems, 21 CFR Product Code: 892.2050 Viewpoint 5.0 K050943 Predicate Device(s): K061682 Voluson E8 4D View 9.1 is a standalone Software product, which can be Device Description: installed only on a PC with Microsoft Windows Vista operating systems: Primary Operating Functions are: · Display and editing of GE Ultrasound 3D/4D data sets · Measurements on displayed image incl. derived calculations which are all based on medical literature in the following applications: Abdominal, Obstetrics, Gynecology, Cardiology, Urology, Vascular, Neurology, Small Parts, Pediatrics, Musculo-Skeletal (Orthopedics). · Data storage (image, measurement and patient data) · Data transfer to and from remote systems (e.g. via DICOM) · Adding annotations to acquired image Same measurements and calculations are available on the predicate devices Image Display of GE Ultrasound 3D/4D ultrasound data sets for Intended Use: diagnostic purposes including measurements on displayed image.

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K101166
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The 4D VIEW 9.1 employs the same fundamental scientific Technology: technology as its predicate devices.

Determination of Substantial Equivalence: ·

Summary of Non-Clinical Tests:

The 4D VIEW 9.1 and its applications comply with voluntary standards as detailed in Section 9, 11 and 17 of this premarket submission. The following quality assurance measures were applied to the development of the system:

. Risk Analysis
Requirements Reviews .
Design Reviews .
Performance testing (Verification) .
Simulated use testing (Validation) .

Summary of Clinical Tests:

The subject of this premarket submission, 4D-View 9.1, did not require clinical studies to support substantial equivalence.

GE Healthcare considers the 4D-VIEW 9.1 to be as safe, as Conclusion: effective, and performance is substantially equivalent to the predicate device(s).

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized graphic of an eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the graphic.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

Mr. Bryan Behn Regulatory Affairs Manager GE Healthcare GE Medical Systems, Ultrasound and Primary Care Diagnostics, LLC 9900 Innovation Drive WAUWATOSA WI 53226-4856

OCT 07 2010

Re: K101166

Trade/Device Name: 4D-VIEW 9.1 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: April 22, 2010 Received: April 26, 2010

Dear Mr. Behn:

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. Ilsting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into class II (Special Controls). it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

signature

David G. Brown, Ph.D. . Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K101166

Device Name: 4D-VIEW 9.1

Indications for Use:

Image Display of GE Ultrasound 3D/4D data sets for diagnostic purposes including measurements on displayed image.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use N/A (Part 21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

(Division Sign-Off)

Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) Number 101160

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).