Stroke VCAR is a CT image analysis software package that provides information to physicians to assist them in the analysis and visualization of Brain CT data derived from DICOM 3.0 compliant CT scans. Stroke VCAR is designed for the purpose of segmenting and assessing intracerebral and intracranial hemorrhages in the brain using semi-automated tools on non-contrast CT exams. Additionally Stroke VCAR provides a set of workflow tools for the segmentation and visualization of aneurysms in the brain from contrast enhanced CT exams. It is intended for use by clinicians to process, review, archive, print and distribute CT studies.

This software will assist the user by providing initial 3D segmentation, measurements and visualization of hemorrhages and aneurysm in the brain. The user has the ability to adjust, review and has to confirm the final segmentation.

Device Description

Stroke VCAR is intended to provide 2D and 3D processing, review and analysis of CT images originally acquired to evaluate the cerebral vascular system and/or intracranial bleeding. The combination of the acquired images, reconstructed images, and measurements performed by the clinician using Stroke VCAR are intended to provide the referring physician clinically relevant information for the purpose of diagnosis, treatment planning and follow-up.

AI/ML Overview

Here's an analysis of the provided text regarding the Stroke VCAR device, focusing on acceptance criteria and the supporting study:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state numerical acceptance criteria in terms of performance metrics (e.g., accuracy, sensitivity, specificity, Dice score, etc.) for the Stroke VCAR device. Instead, the "Summary of Clinical tests" section details observed benefits and qualitative feedback. The closest "performance" reported relates to workflow time improvement.

Feature/Metric	Acceptance Criteria (Explicitly Stated)	Reported Device Performance
Hematoma Segmentation Workflow Time	(Not explicitly stated as a numerical criterion, but implicitly tied to "productivity benefits")	The workflow time to perform automated hematoma segmentation utilizing the Stroke VCAR hematoma edition tool was significantly less than the workflow time to perform hematoma segmentation manually. (Specific time savings or statistical significance not quantified in this summary, but strongly implied as positive).
Diagnostic Value	(Not explicitly stated as a numerical criterion)	Study results clearly show that Stroke VCAR adds diagnostic value to the current hematoma and aneurysm clinical workflow and is a useful tool for neuroradiologists, providing comprehensive stroke work-up including automated hematoma and aneurysm processing and analysis, quantification, and monitoring. (Qualitative assessment).
User Feedback	(Not explicitly stated as a numerical criterion)	General user qualitative feedbacks of the Stroke VCAR edition tools (Part 2a and Part 2b) – no specific feedback details are provided in this summary, but it's implied to be positive in conjunction with the diagnostic value statement.

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

The text states: "A clinical evaluation study using consented clinical images was conducted..."

Sample Size for Test Set: The specific number of cases (clinical images) used in the study is not explicitly stated. It mentions "consented clinical images," but gives no numerical quantity.
Data Provenance (e.g., country of origin, retrospective or prospective): "Consented clinical images" suggests real-world data, likely retrospective, but the country of origin is not specified.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Number of Experts: Three board-certified neuroradiologists were used in Part 2a and Part 2b of the study.
Qualifications of Experts: They were identified as "board certified neuroradiologists" and "considered experts."

4. Adjudication Method for the Test Set

The document does not explicitly state an adjudication method (such as 2+1 or 3+1 consensus) for establishing the ground truth or evaluating the device's output. It mentions "three board certified neuroradiologists" but not how their assessments were combined or reconciled.

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

The study described does not appear to be a traditional MRMC comparative effectiveness study in the sense of comparing reader performance with and without AI assistance on diagnostic accuracy metrics.

Instead, the study's stated goals were:

"Productivity benefits of automated vs. manual hematoma segmentation (Part 1)"
"General user Qualitative feedbacks of the Stroke VCAR edition tools (Part 2a and Part 2b)"

While it compares automated vs. manual workflow time, it doesn't quantify diagnostic accuracy improvement for human readers using the AI. Therefore, an effect size of human reader improvement with vs. without AI assistance is not reported.

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

The provided text does not explicitly describe a standalone performance study of the algorithm without human-in-the-loop. The description states: "This software will assist the user by providing initial 3D segmentation, measurements and visualization of hemorrhages and aneurysm in the brain. The user has the ability to adjust, review and has to confirm the final segmentation." This indicates that the device is intended for semi-automated use where the human user confirms the results, implying that standalone performance may not be the primary evaluation focus here.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

Given the involvement of "three board certified neuroradiologists" who "were considered experts" in the clinical evaluation, the ground truth for evaluating the device's output (specifically for "diagnostic value" and potentially the accuracy of the automated segmentations) was likely based on expert consensus or expert interpretation of the clinical images. There's no mention of pathology or outcomes data as ground truth.

8. The Sample Size for the Training Set

The provided text does not specify the sample size for the training set used to develop the Stroke VCAR software. The "Summary of Non-Clinical Tests" mentions that "Stroke VCAR optimizes the segmentation algorithms for Hematoma segmentation and Aneurysm segmentation," implying training, but no details on the training data are given.

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

The provided text does not describe how the ground truth for the training set was established.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of two main elements: a circular text element and a symbol. The text element reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion. The symbol is a stylized representation of three human profiles facing to the right, with flowing lines beneath them.

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

January 20, 2016

Ge Medical Systems SCS % Jeme Wallace Regulatory Affairs Director GE Healthcare 540 W Northwest Highway BARRINGTON IL 60010

Re: K152584

Trade/Device Name: Stroke VCAR Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: December 17, 2015 Received: September 18, 2015

Dear Jeme Wallace:

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, 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 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Robert Oolo

Robert Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K152584

Device Name Stroke VCAR

Indications for Use (Describe)

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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Image /page/3/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'g' and 'e' intertwined in a stylized script, enclosed within a blue circle. The circle is surrounded by a decorative, swirling pattern, also in blue, giving the logo a classic and recognizable appearance.

510(k) Summary

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

Date:	September 9, 2015
Submitter:	GE Medical Systems SCS
	283, rue de la Minière
	78530 Buc, France
Primary Contact Person:	Peter Uhlir
	Regulatory Affairs Leader
	Tel: 00 36 1 4793318
	Fax: (847) 277 5240
Secondary ContactPerson:	Jeme Wallace
	Regulatory Affairs Director
	GE Healthcare
	Tel: (847) 277 4468
	Fax: (847) 277 5240
Device Trade Name:	Stroke VCAR
Common/Usual Name:	Stroke VCAR
Classification Names:	21CFR 892.1750, Radiology
Product Code:	JAK
Predicate Device(s):	K041521 - Volume Viewer Plus
Device Description /Intended Use:	Stroke VCAR is intended to provide 2D and 3D processing,review and analysis of CT images originally acquired to evaluatethe cerebral vascular system and/or intracranial bleeding. Thecombination of the acquired images, reconstructed images,and measurements performed by the clinician using StrokeVCAR are intended to provide the referring physician clinicallyrelevant information for the purpose of diagnosis, treatmentplanning and follow-up.
Indications for Use:	Stroke VCAR is a CT image analysis software package thatprovides information to physicians to assist them in the analysisand visualization of Brain CT data derived from DICOM 3.0compliant CT scans. Stroke VCAR is designed for the purpose ofsegmenting and assessing intracerebral and intracranialhemorrhages in the brain using semi-automated tools on non-contrast CT exams. Additionally Stroke VCAR provides a set ofworkflow tools for the segmentation and visualization ofaneurysms in the brain from contrast enhanced CT exams. It isintended for use by clinicians to process, review, archive, printand distribute CT studies.This software will assist the user by providing initial 3D segmentation, measurements and visualization of hemorrhages and aneurysm in the brain. The user has the ability to adjust, review and has to confirm the final segmentation.
Technology:	The Stroke VCAR software employs the same fundamentalscientific technology as its predicate device.
Determination ofSubstantial Equivalence:	Summary of Non-Clinical Tests:The Stroke VCAR software complies with NEMA PS 3.1 - 3.20(2011) Digital Imaging and Communications in Medicine (DICOM)Set (Radiology) standard.The Stroke VCAR software employs the same fundamentalscientific technology as its predicate device (Volume Viewer).Stroke VCAR SW uses the equivalent CT DICOM image datainput requirements. It has equivalent display, formatting,archiving and visualization technologies compared to thepredicate device. Stroke VCAR utilizes the enhancedsegmentation tools (threshold, auto-select) already found inVolume Viewer and optimizes the segmentation algorithms for Hematoma segmentation and Aneurysm segmentation.Thorough testing of these capabilities has not raised any safety or effectiveness issues.The following quality assurance measures were applied to the development of the system:Risk Analysis Requirements Reviews Design Reviews Integration testing (System verification) Performance testing (Bench testing, validation) Safety testing (Verification)
	Summary of Clinical tests:
	A clinical evaluation study using consented clinical images wasconducted by three CT technologists in Part 1 and three boardcertified neuroradiologists in Part 2a and Part 2b who wereconsidered experts. The study was meant to assess thefollowing:
	■ Productivity benefits of automated vs. manual hematomasegmentation (Part 1)■ General user Qualitative feedbacks of the Stroke VCARedition tools (Part 2a and Part 2b)
	The study results demonstrated that the workflow time toperform automated hematoma segmentation utilizing theStroke VCAR hematoma edition tool was significantly less thanthe workflow time to perform hematoma segmentationmanually.
	Additionally study results clearly show that Stroke VCAR addsdiagnostic value to the current hematoma and aneurysmclinical workflow and is a useful tool for neuroradiologists toproviding comprehensive stroke work-up including automatedhematoma and aneurysm processing and analysis,quantification and monitoring.
	The substantial equivalence determination is based on thesoftware documentation for a MODERATE level of concerndevice.
Conclusion:	GE Healthcare considers the Stroke VCAR software applicationto be as safe, as effective, and performance is substantiallyequivalent to the predicate device.

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Image /page/4/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 swirling lines around the letters, giving the impression of movement or energy. The logo is simple and recognizable, and it is often used to represent the company's brand.

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Image /page/5/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' in a stylized script, enclosed within a blue circle. The circle has a swirling pattern around the letters, giving it a dynamic and recognizable appearance.

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.