Liver Suite is an aiding tool for the clinician to review multi-phase liver CT images following LI-RADS® guidelines. Liver Suite is designed to help analyzing liver lesions in patients with known or suspected hepatocellular carcinoma (HCC). It provides optimized series display and a guided workflow to assess relevant clinical features for user-defined observations, to enable computation of a LI-RADS score. It is intended for use by healthcare professionals. The clinician remains ultimately responsible for the final assessment and diagnosis based on state-of-the-art practices, clinical judgment and interpretation of liver images or quantitative data.

Device Description

Liver Suite is a medical software that offers a guided workflow for the review and assessment of multi-phase CT liver exams per LI-RADS® v2018 guidelines. It is designed to help analyze liver lesions in patients with known or suspected hepatocellular carcinoma (HCC) by providing optimized image display and assessment of intensity metrics related to the 3 major imaging features for LI-RADS scoring. Liver Suite takes phased contrast CT series as input. It only processes one exam at a time (no longitudinal analysis). Liver Suite guided workflow includes: Automatic phase identification of the four hepatic imaging phases: unenhanced, arterial, portal venous and delayed; Semi-automatic lesion contouring based on an initial deposition from the user, user selects applicable appropriate score (LRNC, LR-TIV, LR-1, LR-2 or LR-M) based on image review; A user interface to guide the user in the application of LI-RADS scoring guidelines v2018; User sets the features - non-rim APHE (Yes/No), Enhancing Capsule (Yes/No), Non-peripheral washout (Yes/No), Threshold growth (Yes/No/Not Applicable), Ancillary Features; Automated computation of intensity metrics to help characterize Arterial Phase -Hyper Enhancement (APHE), Washout and Capsule; Automated calculation of LI-RADS score (per LI-RADS v2018 guidelines) from user assessment of major and ancillary features; Display of all measurements in a table for review and export. Identification of hepatic phases is based on a model-based algorithm or can be set manually by the user. Semi-automatic contouring of the lesion is based on the Auto Contour feature and user input. The Auto Contour feature is already part of Volume Viewer (K041521). User sets LI-RADS major and ancillary features and compute associated LI-RADS score. To assist with the assessment of Arterial Phase Hyper Enhancement (APHE), Washout and Capsule, intensity metrics based on enhancement characteristics around the lesion are automatically computed. LI-RADS score is computed based on LI-RADS features using LI-RADS diagnostic table. User can edit the major features, add ancillary features or manually choose a different score.

AI/ML Overview

The provided text does not contain detailed information about the acceptance criteria and the study that proves the device meets those criteria, specifically concerning the performance metrics of the Liver Suite software. It primarily outlines the regulatory approval process (510(k) pathway), the device's intended use, and a comparison to predicate devices.

However, based on the information provided, we can infer some aspects and highlight what is missing for a complete answer to your query:

Here's an attempt to structure the answer based on the available text, with
[Information Not Provided] for missing details:

Acceptance Criteria and Device Performance Study for Liver Suite (K211180)

The provided documentation, a 510(k) summary, focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance rather than a detailed clinical performance study with specific acceptance criteria and results. Therefore, many of the requested details about performance metrics, study design, and ground truth establishment are not explicitly stated.

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not specify quantitative acceptance criteria or a dedicated performance table for the Liver Suite's accuracy in LI-RADS scoring or lesion characterization. Instead, it mentions "Algorithm Qualification (Validation)" and verification activities.

Feature/Metric	Acceptance Criteria	Reported Device Performance
Automatic Phase Identification	Capability to identify phases	Demonstrated the capabilities to identify automatically the two, three, or four phases acquired on multi-phase CT images for LI-RADS scoring.
APHE, Washout, Capsule Intensity Metric Calculation Accuracy	[Quantitative Criteria Not Provided]	Verified through testing on synthetic images and validated by comparing intensity metric distribution on a set of expert-annotated lesions. (The specific results of this comparison, e.g., correlation, difference ranges, or statistical significance, are not provided).
Overall LI-RADS Score Computation Accuracy	[Quantitative Criteria Not Provided]	The device "enables computation of a LI-RADS score" and "Automated calculation of LI-RADS score (per LI-RADS v2018 guidelines) from user assessment of major and ancillary features." No specific accuracy/agreement metric against a ground truth for the computed score is stated. The clinician remains ultimately responsible.
Lesion Contouring Accuracy	[Quantitative Criteria Not Provided]	"Semi-automatic contouring of the lesion is based on the Auto Contour feature and user input." Auto Contour feature is part of Volume Viewer (K041521). It is implied that the user can review and edit the contour.

2. Sample Size and Data Provenance for the Test Set:

Test Set Sample Size: [Not Provided] The document refers to "a set of expert-annotated lesions" for validating intensity metric distribution, but the number of lesions or cases is not specified.
Data Provenance: [Not Provided] The country of origin and whether the data was retrospective or prospective are not mentioned.

3. Number of Experts and Qualifications for Ground Truth Establishment:

Number of Experts: [Not Provided] The document mentions "expert-annotated lesions" but does not specify the number of experts involved.
Qualifications of Experts: [Not Provided] No details on the qualifications (e.g., specific medical specialty, years of experience, board certification) of the experts are provided.

4. Adjudication Method for the Test Set:

Adjudication Method: [Not Provided] The method used to establish ground truth from multiple experts (e.g., 2+1, 3+1 consensus, majority vote) or if a single expert was used, is not described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

MRMC Study: [Not Provided] There is no mention of an MRMC study comparing human readers with AI assistance versus without AI assistance. The device is described as an "aiding tool" for the clinician, but no data on its impact on human reader performance is presented.
Effect Size of Improvement: [Not Applicable, as no MRMC study details are provided]

6. Standalone (Algorithm Only) Performance Study:

Standalone Study: The document implies some standalone algorithmic validation for specific components:
- "Engineering bench testing for the Liver Suite Phase Identification algorithm demonstrated the capabilities to identify automatically the two, three or four phases acquired on multi-phases CT images for LI-RADS scoring." No quantitative metrics (e.g., accuracy, sensitivity, specificity) for this standalone performance are given.
- "APHE. Washout and Capsule intensity metric calculation was verified through testing on synthetic images and validated by comparing intensity metric distribution on a set of expert-annotated lesions." This suggests an algorithm-only evaluation for these specific calculations, but again, no quantitative results are provided.
  However, a comprehensive standalone performance study for the entire LI-RADS scoring process (algorithm-computed score vs. ground truth) is not described.

7. Type of Ground Truth Used:

Type of Ground Truth: "Expert-annotated lesions" were used for validating intensity metric distribution. This indicates expert consensus/interpretation as the ground truth for those specific features. No mention of pathology or outcomes data is made. For the overall LI-RADS score, the system computes it based on user input of features, implying the ground truth for the features would be expert interpretation, and the algorithm's role is to correctly compute the score based on those user-provided features.

8. Sample Size for the Training Set:

Training Set Sample Size: [Not Provided] The document does not specify the size of any training dataset used for the underlying models (e.g., phase identification, auto-contouring, or intensity metric calculations).

9. How Ground Truth for the Training Set was Established:

Training Set Ground Truth Establishment: [Not Provided] The method for establishing ground truth for any training data (e.g., expert annotation, specific criteria, adjudication process) is not detailed.

Summary

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

May 2, 2022

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and "ADMINISTRATION" in a smaller font size below.

GE Medical Systems SCS % Peter Uhlir Regulatory Affairs Leader 283, rue de la Minière Buc. 78530 FRANCE

Re: K211180

Trade/Device Name: Liver Suite Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II Product Code: JAK, LLZ Dated: April 25, 2022 Received: April 26, 2022

Dear Peter Uhlir:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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

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

801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Laurel Burk Assistant Director Diagnostic X-ray Systems Team DHT 8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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

Indications for Use

510(k) Number (if known)

K211180

Device Name

Liver Suite

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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

K211180

Image /page/3/Picture/2 description: The image shows the logo for General Electric (GE). The logo consists of the letters "GE" in a stylized script, enclosed within a blue circle. The circle has a decorative, swirling design around the letters, giving it a distinctive and recognizable appearance. The logo is simple, yet elegant, and is widely recognized as the symbol of the General Electric company.

510(k) Summary

In accordance with 21 CFR 807.92 the following summary of information is provided:

Date:	May 2, 2022
Submitter:	GE Medical Systems SCSEstablishment Registration Number - 9611343283 rue de la Minière78530 Buc, France
Primary Contact:	Peter UhlirRegulatory Affairs LeaderGE Healthcare, (GE Medical Systems SCS)Phone: +36 70 436 9317Email: peter.uhlir@ge.com
Secondary Contact:	Camille VidalDirector, Regulatory StrategyPhone: (240) 280-5356Email: camille.vidal@ge.com
Proposed Device:
Device Name:	Liver Suite
Common/Usual Name:	Liver Suite
Regulation number/ Product Code:	21 CFR 892.1750 Computed tomography x-ray system / JAK21 CFR 892.2050 Medical image management and processing system / LLZ
Classification:	Class II
Predicate Device:
Device Name:	Hepatic VCAR
510(k) number:	K193281 cleared on March 20, 2020
Regulation number/ Product Code:	21 CFR 892.1750 Computed tomography x-ray system / JAK21 CFR 892.2050 Picture archiving and communication system / LLZ
Classification:	Class II
Manufacturer:	GE Medical Systems SCS
Device Name:	PROView
510(k) number:	K193306 cleared on November 17, 2020
Regulation number/ Product Code:	21 CFR 892.2050 Picture archiving and communication system / LLZ
Classification:	Class II
Manufacturer:	GE Medical Systems SCS

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

Image /page/4/Picture/1 description: The image shows the logo for General Electric (GE). The logo consists of the letters 'GE' written in a stylized script, enclosed within a blue circle. The letters are white, creating a contrast against the blue background. The logo is simple, recognizable, and represents the brand identity of General Electric.

Reference Device:

Liver Suite is a medical software that offers a guided workflow for the review and Device Description: assessment of multi-phase CT liver exams per LI-RADS® v2018 guidelines. It is designed to help analyze liver lesions in patients with known or suspected hepatocellular carcinoma (HCC) by providing optimized image display and assessment of intensity metrics related to the 3 major imaging features for LI-RADS scoring.

Liver Suite takes phased contrast CT series as input. It only processes one exam at a time (no longitudinal analysis).

Liver Suite guided workflow includes:

Automatic phase identification of the four hepatic imaging phases: unenhanced, arterial, portal venous and delayed
Semi-automatic lesion contouring based on an initial deposition from the user, user selects applicable appropriate score (LRNC, LR-TIV, LR-1, LR-2 or LR-M) based on image review
-A user interface to guide the user in the application of LI-RADS scoring guidelines v2018
-User sets the features - non-rim APHE (Yes/No), Enhancing Capsule (Yes/No), Non-peripheral washout (Yes/No), Threshold growth (Yes/No/Not Applicable), Ancillary Features
Automated computation of intensity metrics to help characterize Arterial Phase -Hyper Enhancement (APHE), Washout and Capsule
Automated calculation of LI-RADS score (per LI-RADS v2018 guidelines) from user assessment of major and ancillary features
Display of all measurements in a table for review and export

Identification of hepatic phases is based on a model-based algorithm or can be set manually by the user. Semi-automatic contouring of the lesion is based on the Auto Contour feature and user input. The Auto Contour feature is already part of Volume Viewer (K041521).

User sets LI-RADS major and ancillary features and compute associated LI-RADS score. To assist with the assessment of Arterial Phase Hyper Enhancement (APHE), Washout and Capsule, intensity metrics based on enhancement characteristics around the lesion are automatically computed.

LI-RADS score is computed based on LI-RADS features using LI-RADS diagnostic table. User can edit the major features, add ancillary features or manually choose a different score.

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

Image /page/5/Picture/1 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 border. There are three water droplet-like shapes evenly spaced around the outside of the circle. The logo is colored in a light blue hue.

Liver Suite is a medical diagnostic software that provides the clinician with tools to Intended Use: efficiently process, analyze, review and communicate to peers findings from liver CT image data. The combination of acquired images, reconstructed images, annotations and measurements performed by the clinician are intended to provide the referring physician with clinically relevant information that may aid in diagnosis and patient management.
Indication for Use: Liver Suite is an aiding tool for the clinician to review multi-phase liver CT images following LI-RADS® guidelines. Liver Suite is designed to help analyzing liver lesions in patients with known or suspected hepatocellular carcinoma (HCC). It provides optimized series display and a guided workflow to assess relevant clinical features for user-defined observations, to enable computation of a LI-RADS score. It is intended for use by healthcare professionals. The clinician remains ultimately responsible for the final assessment and diagnosis based on state-of-the-art practices, clinical judgment and interpretation of liver images or quantitative data.
- Technology: Liver Suite software provides a workflow to assess hepatocellular carcinoma following LI-RADS guidelines using multi-phase liver CT images which are routine acquisitions, systematically done by the clinician for liver cancer assessment in case of hepatocellular carcinoma, as it is part of LI-RADS guidelines.

Liver Suite is a post processing application option that is intended for the analysis of CT liver images. It is embedded in Volume Viewer (K041521). Volume Viewer is a platform of 3D applications that provides at the same time an autonomous set of layouts, protocols and tools for the user and common framework to build other specialty 3D applications on top of Volume Viewer, such as proposed application Liver Suite. Liver Suite and Volume Viewer run on AW VolumeShare Workstation (K110834) and AW Server (K081985) platforms, Cloud or PACS stations

The table below summarizes the feature/technological comparison between the predicate Comparison: device and the proposed device:

Specification	Predicate Device:Hepatic VCAR (K193281)	Proposed Device:Liver Suite
Targeted clinicalcondition,anatomy andimagingmodality	Clinical condition: patientwith suspected or knownliver lesions. Anatomy:Liver; Imaging modality:CT	Clinical condition: patient withsuspected or known HCCs,which are a type of liverlesions. Anatomy: Liver;Imaging modality: CT
Lesioncharacterization	Automatic characterizationof the lesion volume basedon maximum 2D diametergiven manually by the user.	Automatic characterization ofthe lesion volume based onmaximum 2D diameter givenmanually by the user.
	User can review and editthe contour. Once accepted,the following statistics areavailable:	User can review and edit thecontour. Once accepted, thefollowing statistics areavailable:
	- lesion volume	- lesion volume
	- lesion 2D max and shortaxis

{6}------------------------------------------------

Image /page/6/Picture/1 description: The image shows the logo for General Electric (GE). The logo is a blue circle with the letters "GE" in a stylized font in the center. There are three white swirls around the outside of the circle. The logo is simple and recognizable.

- lesion HU values (min,max, average, standarddeviation)	- lesion 2D max and short axis- lesion HU values (min, max,average, standard deviation)- 3 intensity metrics: ArterialPhase Hyper Enhancement(APHE), Washout and Capsulebased on analysis of intensityenhancement differencesbetween the lesion andadjacent parenchyma.User sets LI-RADS major andancillary features in workflowpanel to enable computation ofthe associated LI-RADS score.
Automatic phaseidentification	Automatic detection of portalphase based on imageinformation.User can modify seriesdisplay if needed.	Automatic detection ofuncontrasted, arterial, portal anddelayed phase based on astatistical model using imageand acquisition information.User can modify series display ifneeded.
Summary ReportContent	Organ type bookmarks:• Liver• Portal Vein• Hepatic Artery• SegmentLesion type bookmarks:• Lesion	For each lesion ObservationAnalysis finding:• Observation size• Observation majorfeatures• Observation ancillaryfeatures• Observation LI-RADSscore

Specification	Reference Device:PROView (K193306)	Proposed Device:Liver Suite
Computation ofPI/LI-RADS score	Based on user input onlocation and assessmentFollowing PI-RADS™ v2.1guidelines	Based on user input on majorand ancillary featuresFollowing LI-RADS® v2018guidelines

Determination of

Substantial Equivalence:

The proposed device, Liver Suite, has successfully completed the required design control testing per GE Healthcare Quality Management System. Liver Suite was designed and will be manufactured under the Quality System Regulations of 21CFR 820 and ISO

{7}------------------------------------------------

Image /page/7/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' written in a stylized script, enclosed within a blue circle. The circle has small, white, droplet-like shapes around its perimeter, giving it a dynamic and fluid appearance.

13485:2016. The proposed device complies with NEMA PS 3.1 - 3.20 (2016) Digital Imaging and Communications in Medicine (DICOM) Set (Radiology) standard.

The following quality assurance measures have been applied to the development of the system:

. Risk Analysis
. Required Reviews
. Design Reviews
. Software Development Lifecycle
Performance testing (Verification)
. Safety testing (Verification)
Algorithm Qualification (Validation)

Liver Suite has been verified on AW workstation (K110834) and AW Server (K081985) platforms. The substantial equivalence was also based on software documentation for a "Moderate" level of concern device.

Engineering bench testing for the Liver Suite Phase Identification algorithm demonstrated the capabilities to identify automatically the two, three or four phases acquired on multi-phases CT images for LI-RADS scoring.

APHE. Washout and Capsule intensity metric calculation was verified through testing on synthetic images and validated by comparing intensity metric distribution on a set of expert-annotated lesions.

Conclusion: GE Healthcare considers the Liver Suite software application to be as safe, as effective, and performance is substantially equivalent to the predicate device.

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.