FastStroke is a CT image analysis software package that assists in the analysis and visualization of CT data derived from DICOM 3.0 compliant CT scans. FastStroke is intended for the purpose of displaying vasculature of the head and neck at different time points of enhancement.
The software will assist the user by providing optimized display settings to enable fast review of the images in synchronized formats, aligning the display of the images to the order of the scans and linking together multiple groups of scans. In addition, the software fuses the vascular information from different time points into a single colorized view. This multiphase information can aid the physician in visualizing the presence or absence of collateral vessels in the brain. Collateral vessel information may aid the physician in the evaluation of stroke patients.
FastStroke device has been tested with DICOM images from Discovery CT750 HD and Revolution CT using multi-phase CT Angiography. FastStroke is based on DICOM image based processing and would apply to any CT device that is able to acquire data in an equivalent multi-phase CT angiography (pursuant to the timing protocols in the user quide) manner.
FastStroke is also made available as a standalone post processing application on the AW VolumeShare workstation (K110834) and AW Server platform (K081985) that host advanced image processing applications.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study details for the FastStroke device based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state quantitative acceptance criteria or direct performance metrics for the FastStroke device in a table format. Instead, it describes the purpose of the study as assessing increased diagnostic capability using Likert scales and concludes that "FastStroke aids the physician in visualizing the presence or absence of collateral vessels in the brain and is a useful tool for neuroradiologists in providing a comprehensive stroke work-up."

Acceptance Criteria (Implied)	Reported Device Performance
Aid physicians in visualizing presence/absence of collateral vessels in the brain.	The study results show that FastStroke aids the physician in visualizing the presence or absence of collateral vessels in the brain.
Be a useful tool for neuroradiologists in comprehensive stroke work-up.	The study results show that FastStroke is a useful tool for neuroradiologists in providing a comprehensive stroke work-up.
Compliance with NEMA PS 3.1 - 3.20 (2016) DICOM Set (Radiology) standard.	The FastStroke software complies with NEMA PS 3.1 - 3.20 (2016) Digital Imaging and Communications in Medicine (DICOM) Set (Radiology) standard.
Employ the same fundamental scientific technology as the predicate device.	The FastStroke software employs the same fundamental scientific technology as its predicate device.
Uses equivalent CT DICOM image data input requirements as the predicate device.	FastStroke software uses the equivalent CT DICOM image data input requirements.
Has equivalent display, formatting, archiving, and visualization technologies compared to the predicate device.	It has equivalent display, formatting, archiving and visualization technologies compared to the predicate device.
Utilizes thresholding and fusion similar to the predicate device.	FastStroke utilizes the thresholding and fusion (implied similar to predicate).
Performance to be substantially equivalent to the predicate device.	GE Healthcare considers the FastStroke software application to be as safe, as effective, and performance is substantially equivalent to the predicate device.

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

Sample Size for Test Set: The sample size for the clinical evaluation (test set) is not explicitly stated in the provided document. It only mentions "a retrospective clinical evaluation was conducted."
Data Provenance: The study was a retrospective clinical evaluation. The country of origin of the data is not specified.

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

Number of Experts: Three experts were used.
Qualifications of Experts: They were described as "board certified neuroradiologists who were considered experts."

4. Adjudication Method for the Test Set

The document does not explicitly state the adjudication method used for the clinical evaluation. It only mentions that the primary endpoint was assessed by three experts using multiple 5-point Likert Scales.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly stated to be performed to measure improvement with AI vs. without AI assistance. The study described was a clinical evaluation by neuroradiologists assessing the device's aid in visualization. While it involved multiple readers, it wasn't framed as a direct comparison of human readers with and without AI assistance to quantify an "effect size" in reader performance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

A standalone performance evaluation of the algorithm without human-in-the-loop was not explicitly described or quantified in the provided text as part of the clinical study. The device is described as "assisting the user" and "aiding the physician," indicating a human-in-the-loop design.

7. Type of Ground Truth Used

The ground truth for the clinical evaluation study was established through expert consensus/interpretation by the three board-certified neuroradiologists. The study assessed the device's ability to "aid the physician in visualizing the presence or absence of collateral vessels," implying that the experts' assessment of visualization aided by the device served as the "truth" for the study's purpose.

8. Sample Size for the Training Set

The document does not provide any information about the sample size used for the training set of the FastStroke software.

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

The document does not provide any information on how the ground truth for the training set (if any) was established. It primarily focuses on the clinical evaluation used for substantial equivalence.

Summary

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

January 26, 2017

GE Medical Systems SCS % Ms. Kristine Schraufnagel Regulatory Affairs Manager 283 rue de la Miniere Buc. Yvelines 78530 FRANCE

Re: K163281

Trade/Device Name: FastStroke Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: January 23, 2017 Received: January 24, 2017

Dear Ms. Schraufnagel:

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.

Michael D. O'Hara

For

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) K163281

Device Name FastStroke

Indications for Use (Describe)

The software will assist the user by providing optimized display settings to enable fast review of the images in synchronized formats, aligning the display of the images to the order of the scans and linking together multiple groups of scans. In addition, the software fuses the vascular information from different time points into a single colorized view. This multiphase information can aid the physician in visualizing the presence of collateral vessels in the brain. Collateral vessel information may aid the physician in the evaluation of stroke patients.

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary

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

Date:	January 23, 2017
Submitter:	GE Medical Systems SCS283, rue de la Minière78530 Buc, France
Primary Contact Person:	Kristine SchraufnagelRegulatory Affairs ManagerTel: (262) 312 7344Fax: (262) 548 2317
Secondary Contact Person:	Jeme ErtlRegulatory Affairs DirectorGE HealthcareTel: (847) 277 4468Fax: (847) 277 5240
Device Trade Name:	FastStroke
Common/Usual Name:	FastStroke
Regulation Number:	21CFR 892.1750
Regulation Name:	Computed Tomography X-ray System
Classification Panel:	Radiology
Regulatory Class:	Class II
Product Code:	JAK
Predicate Device:	K041521 - Volume Viewer Plus
Regulation Number:	21CFR 892.1750
Regulation Name:	Computed Tomography X-ray System
Regulation Number:	21CFR 892.1000
Regulation Name:	Magnetic Resonance Diagnostic Device
Regulatory Class:	Class II
Product Code:	JAK and LNH
Device Description /Intended Use:	FastStroke is a CT image analysis software package thatassists in the analysis and visualization of CT data derived fromDICOM 3.0 compliant CT scans. FastStroke is intended for the
purpose of displaying vasculature of the head and neck atdifferent time points of enhancement.The software will assist the user by providing optimized displaysettings to enable fast review of the images in synchronizedformats, aligning the display of the images to the order of thescans and linking together multiple groups of scans. In addition,the software fuses the vascular information from different timepoints into a single colorized view. This multiphase informationcan aid the physician in visualizing the presence or absence ofcollateral vessels in the brain. Collateral vessel information mayaid the physician in the evaluation of stroke patients.
FastStroke device has been tested with DICOM images fromDiscovery CT750 HD and Revolution CT using multi-phase CTAngiography. FastStroke is based on DICOM image basedprocessing and would apply to any CT device that is able toacquire data in an equivalent multi-phase CT angiography(pursuant to the timing protocols in the user quide) manner.
FastStroke is also made available as a standalone postprocessing application on the AW VolumeShare workstation(K110834) and AW Server platform (K081985) that hostadvanced image processing applications.
Indications for Use:	FastStroke is a CT image analysis software package thatassists in the analysis and visualization of CT data derived fromDICOM 3.0 compliant CT scans. FastStroke is intended for thepurpose of displaying vasculature of the head and neck atdifferent time points of enhancement.The software will assist the user by providing optimized displaysettings to enable fast review of the images in synchronizedformats, aligning the display of the images to the order of thescans and linking together multiple groups of scans. In addition,the software fuses the vascular information from different timepoints into a single colorized view. This multiphase informationcan aid the physician in visualizing the presence or absence ofcollateral vessels in the brain. Collateral vessel information mayaid the physician in the evaluation of stroke patients.
Technology:	The FastStroke software employs the same fundamentalscientific technology as its predicate device.
Determination ofSubstantial Equivalence:	Summary of Non-Clinical Tests:The FastStroke software complies with NEMA PS 3.1 - 3.20(2016) Digital Imaging and Communications in Medicine (DICOM)Set (Radiology) standard.The FastStroke software employs the same fundamentalscientific technology as its predicate device (Volume Viewer).FastStroke software uses the equivalent CT DICOM image datainput requirements. It has equivalent display, formatting,archiving and visualization technologies compared to thepredicate device. FastStroke utilizes the thresholding and fusion
	Summary of Clinical tests:
	A retrospective clinical evaluation was conducted by threeboard certified neuroradiologists who were considered experts.The primary endpoint of the study was meant to assess thefollowing using multiple 5-point Likert Scales:
	Demonstrate increased diagnostic capability ofFastStroke in a clinical setting of acute stroke.
	The study results show that FastStroke aids the physician invisualizing the presence or absence of collateral vessels in thebrain and is a useful tool for neuroradiologists in providing acomprehensive stroke work-up.
	The substantial equivalence determination is based on thesoftware documentation for a MODERATE level of concerndevice.
Conclusion:	GE Healthcare considers the FastStroke software application tobe as safe, as effective, and performance is substantiallyequivalent to the predicate device.

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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.