READY View is an image analysis software that allows the user to process dynamic or functional volumetric data and to generate maps that display changes in image intensity over time, echo time, b-value (Diffusion imaging) and frequency (Spectroscopy). The combination of acquired images, reconstructed images, calculated parametric images, tissue segmentation, annotations and measurement performed by the clinician allows multi-parametric analysis and may provide clinically relevant information for diagnosis.

Device Description

READY View is a suite of applications developed to improve multiparametric exams by enabling the analysis of MR generated data sets containing multiple images for each scan location. The MR data sets may be any of the following:

A time series
A diffusion weighted scan
A diffusion tensor scan
A variable echo imaging
A blood oxygen level dependent imaging
Spectroscopy (Single voxel and 2D or 3D CSI)
The READY View platform provides a combination of protocols, applications and tools that enables a fast, easy and quantified analysis of the multiple data sets.
Brain View is a post processing image analysis software package that provides advanced techniques to aid in the diganosis of neurological and oncological diseases. Brain View is an option with the READY View platform and offers two advanced protocols:
FiberTrak
Arterial Spin Labeling (ASL)
READY View along with Brain View option is available on the Advantage Workstation (AW) and Advantage Workstation Server Gen 2, for viewing and processing Magnetic Resonance images.

AI/ML Overview

Here's an analysis of the acceptance criteria and the study information for the GE Healthcare READY View device, based on the provided text.

Based on the provided document, the GE Healthcare READY View device did not require clinical studies to support substantial equivalence. This means that specific acceptance criteria typically associated with clinical performance metrics (like sensitivity, specificity, accuracy, etc.) and a study to prove they were met are not detailed.

Instead, the submission focuses on non-clinical tests to demonstrate its safety, effectiveness, and substantial equivalence to a predicate device.

Here's the breakdown of the requested information, drawing from what's available in the document:

1. A table of acceptance criteria and the reported device performance

Since a clinical study with performance metrics wasn't conducted, the acceptance criteria and performance are based on successful completion of non-clinical tests and demonstration of equivalence to the predicate device.

Acceptance Criteria Category	Specific Criteria (Implicitly Met)	Reported Device Performance/Conclusion
Non-Clinical Testing	- Risk Analysis conducted	- Risk Analysis complete
	- Requirements Reviews conducted	- Requirements Reviews complete
	- Design Reviews conducted	- Design Reviews complete
	- Performance testing (Verification) completed successfully	- Performance testing (Verification) complete and successful
	- Safety testing (Verification) completed successfully	- Safety testing (Verification) complete and successful
	- Simulated use testing (Validation) completed successfully	- Simulated use testing (Validation) complete and successful
Substantial Equivalence	- Device is as safe, as effective, and performance is substantially equivalent to predicate devices (FuncTool K960265 and Volume Viewer Plus K041521).	- "GE Healthcare considers READY View to be as safe, as effective, and performance is substantially equivalent to the predicate devices." The FDA concurred with this determination, stating, "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... You may, therefore, market the device." This implies all equivalence criteria (e.g., similar indications for use, technological characteristics, and performance based on non-clinical testing) were deemed met. The document also states, "The READY View software employs the same algorithm technology as its predicate device FuncTool (K960265)."

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

Sample size for the test set: Not applicable, as no clinical efficacy study with a distinct "test set" of patient data (in the sense of a clinical trial) was performed for this submission. The "test set" for the non-clinical performance and safety testing would have been internal engineering and software validation tests, not patient imaging data reported in the submission in detail.
Data provenance: Not applicable for a clinical test set. The document refers to "MR functional data of the human body acquired from a MR Scanner" for processing by the device, covering targeted anatomies like "Brain, Breast, Prostate, and Liver." However, the origin of specific data used for validation is not specified as it was not a clinical efficacy study.

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

Not applicable. There was no clinical study involving expert consensus on patient cases for ground truth, as the submission relies on substantial equivalence and non-clinical testing.

4. Adjudication method for the test set

Not applicable. No clinical study with a test set requiring adjudication was performed.

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. The document explicitly states: "The subject of this premarket submission, READY View, did not require clinical studies to support substantial equivalence." Therefore, no MRMC study or AI-assisted reader performance evaluation was conducted or reported.

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

Yes, in essence. The "Performance testing (Verification)" and "Simulated use testing (Validation)" described are essentially demonstrations of the algorithm's functionality and performance as a software product. While not described as an "AI algorithm," it's a software application performing image analysis without human intervention during its processing steps. The output of the software (calculated parametric images, graphs, etc.) is then used by a clinician. The focus here is on the software's ability to process data and generate accurate representations, mirroring the algorithms of its predicate devices.

7. The type of ground truth used

For the non-clinical verification and validation activities, the "ground truth" would have been established by engineering specifications, software design documents, and expected outputs based on known input data. For example, if a function calculates a specific parameter, the ground truth would be the mathematically correct calculation of that parameter given predefined input values. The comparison against predicate devices also serves as a form of "ground truth" for functionality and expected output.

8. The sample size for the training set

Not applicable directly. READY View is not presented as a machine learning/AI model that requires a distinct "training set" in the modern sense. It's an image analysis software employing established algorithms, explicitly stated to use "the same algorithm technology as its predicate device FuncTool (K960265)." Therefore, there's no mention of a training set size.

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

Not applicable, as a discrete "training set" for a machine learning model was not used. The algorithms are based on established scientific principles for processing MR functional data, similar to the predicate device.

Summary

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

Image /page/0/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined and enclosed within a circular frame. The letters and the frame are solid black, creating a strong contrast against the white background.

GE Healthcare 510(k) Premarket Notification Submission

510(k) Summary

MAY - 3 2011

In accordance with 21 CFR 807.92 the following summary of information is provided: Date: February 25, 2011

Submitter: GE Healthcare (GE Medical Systems SCS) Establishment Registration Number - 9611343 283, Rue de la Minière 78533 Buc, France
Elizabeth Mathew Primary Contact Person: Regulatory Affairs Leader - MR GE Healthcare, (GE Medical Systems, LLC) Establishment Registration Number - 2183553 3200 N Grandview Blvd., Mail Stop: W-827 Waukesha, WI - 53188, USA Phone: (262) 521-6658 Fax: (262) 521-6439
Secondary Contact Person: Glen Sabin Regulatory Affairs Director - MR GE Healthcare, (GE Medical Systems, LLC) Establishment Reaistration Number - 2183553 3200 N Grandview Blvd., Mail Stop: W-827 Waukesha, WI - 53188, USA Phone: (262) 521-6848 Fax: (262) 364-2785
- Device: Trade Name: READY View
- Common/Usual Name: READY View

Classification Names: 21 CFR 892.2050 Picture archiving and communication system

90 LLZ Product Code:

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

Image /page/1/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" in a stylized, cursive font, enclosed within a circular frame. The letters are connected and have a swirling design. The logo is black and white.

GE Healthcare . 510(k) Premarket Notification Submission

FuncTool Option for Advantage Windows (K960265) Predicate Device(s): Volume Viewer Plus (K041521)

Device Description:

. A time series
A diffusion weighted scan .
A diffusion tensor scan .
. A variable echo imaging
A blood oxygen level dependent imaging .
Spectroscopy (Single voxel and 2D or 3D CSI) ●

The READY View platform provides a combination of protocols, applications and tools that enables a fast, easy and quantified analysis of the multiple data sets.

Brain View is a post processing image analysis software package that provides advanced techniques to aid in the diganosis of neurological and oncological diseases. Brain View is an option with the READY View platform and offers two advanced protocols:

. FiberTrak
. Arterial Spin Labeling (ASL)

READY View along with Brain View option is available on the Advantage Workstation (AW) and Advantage Workstation Server Gen 2, for viewing and processing Magnetic Resonance images.

READY View is an image analysis software that allows the user to Intended Use: process dynamic or functional volumetric data and to generate maps that display changes in image intensity over time, echo time. b-value (Diffusion imaging) and frequency (Spectroscopy). The combination of acquired images, reconstructed images, calculated parametric images, tissue segmentation, annotations and measurement performed by the clinician allows multi-parametric analysis and may provide clinically relevant information for diagnosis.

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

Image /page/2/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined within a circular frame. The letters and the frame are black, contrasting with the white background. The logo is a well-known symbol associated with the multinational conglomerate corporation.

GE Healthcare

510(k) Premarket Notification Submission

Technology:

READY View is a post-processing application processing MR functional data of the human body acquired from a MR Scanner. Taraeted anatomy includes but is not limited to Brain, Breast, Prostate, and Liver.

Functional data sets contain a series of sequentially ordered images for each scan location, where the interval between images can represent time, b-value, echo time, gradient orientation or ppm value (frequency) depending on the data set.

The pixel value in an area of interest at a given scan location may have a different value for each image. To analyze these changes in pixel values, READY View provides two tools:

Graphs: the pixel values at a given pixel location are plotted . as a graph. The graphs can then be represented by the pixel value over the image number or the pixel value over time, bvalue, echo time, gradient orientation or ppm value.
. Functional images: for each pixel location, the pixel values from the images are used to compute a characteristic parameter by means of a function. A functional map is then constructed by displaying the value of the parameter for each pixel location.

The READY View software employs the same algorithm technology as its predicate device FuncTool (K960265), Like FuncTool, READY View provides protocols that enable a fast, easy and quantified analysis of the multiple data sets.

Determination of Substantial Equivalence:

Summary of Non-Clinical Tests:

The following quality assurance measures were applied to the development of READY View:

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

Summary of Clinical Tests:

The subject of this premarket submission, READY View, did not require clinical studies to support substantial equivalence.

GE Healthcare considers READY View to be as safe, as effective, and Conclusion: performance is substantially equivalent to the predicate devices.

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

Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.

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

GE Healthcare (GE Medical Systems SCS) % Ms. Elizabeth Mathew Regulatory Affairs Leader GE Healthcare (GE Medial Systems, LLC) 3200 N. Grandview Blvd., Mail Stop: W-827 WAUKESHA WI 53188

MAY - 3 2011

Re: K110573

Trade/Device Name: READY View Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: February 25, 2011 Received: March 1, 2011

Dear Ms. Mathew:

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 intestate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendmonts, 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, inte not 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 (reporting of

{4}------------------------------------------------

medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) 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 to a legally market 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 (30) 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/Reportals.go to
of Surveillance.and Riometrias/Safety/Reportalers/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 on Consumer Assistance at its toll the (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely Yours,

Mary S Patel

Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

Image /page/5/Picture/0 description: The image shows a sequence of alphanumeric characters, specifically "K110573". The characters are rendered in a bold, sans-serif font, and they appear to be digitally scanned or printed. The contrast between the characters and the background is high, with the characters being black and the background being white.

Image /page/5/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined inside a circle. There are three decorative swirls around the circle, one at the top and two at the bottom.

GE Healthcare 510(k) Premarket Notification Submission

510(k) Number (if known): [INSERT 510(k) NUMBER IF KNOWN] READY View Device Name:

Indications for Use

READY View is an image analysis software that allows the user to process dynamic or functional volumetric data and to generate maps that display changes in image intensity over time, echo time, b-value (Diffusion imaging) and frequency (Spectroscopy). The combination of acquired images, reconstructed images, calculated parametric images, tissue seqmentation, annotations and measurement performed by the clinician allows multiparametric analysis and may provide clinically relevant information for diagnosis.

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

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

ﻴﺔ

(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 Office of In Vitro Diagnostic Device Evaluation and Safety 510(k)

Page 1 of

Mary Spotte
(Division Sign-Off)

Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety

510K K110573

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).