3D ASL allows for generation of maps representing blood flow without the use of an exogenous contrast agent. 3D ASL utilizes water in arterial blood as an endogenous contrast media, to visualize tissue perfusion and evaluate cerebral blood flow (CBF).

When interpreted by a trained physician, images generated by 3D ASL provide information that can be useful in determining a diagnosis.

Device Description

Arterial Spin Labeling (ASL) is an MR technique using the water in arterial blood as an endogenous tracer to evaluate perfusion non-invasively. It provides a non-contrast way to visualize brain perfusion and functional physiology by allowing quantitative cerebral blood flow (CBF) measurements.

GE 3D ASL is an integration of a novel pulsed-continuous labeling technique and a 3D fast spin echo (FSE) acquisition.

The application involves performing inversion of the spins using multiple RF pulses (based on the theory of adiabatic inversion) to label the artery blood spins for the first labeling image. The second image acquisition (also known as control) is performed without inversion of the blood spins. The subtraction of the labeling and control images gives perfusion-weighted images. Additional acquisition of proton density weighted images is then used in combination with the difference images to compute quantitative cerebral blood flow.

The pulsed continuous labeling allows for high labeling efficiency leading to high SNR perfusion images while the 3D FSE readout allows for whole brain coverage and robustness to susceptibility artifacts. The high labeling efficiency is in part due to significantly reduced Magnetization Transfer (MT) effects. The short RF pulses also lead to a significant decrease in the duty cycle when compared to continuous labeling. In addition background suppression is used to reduce the sensitivity of 3D ASL to motion artifacts.

AI/ML Overview

The provided document is a 510(k) summary for GE Healthcare's 3D ASL device. It describes the device, its intended use, and the studies conducted to establish substantial equivalence to predicate devices. However, explicit acceptance criteria values and a detailed breakdown of the study results that directly prove the device meets those criteria are not provided in a concise, easily extractable format. The document focuses on regulatory compliance and general performance validation rather than specific quantitative acceptance criteria for clinical performance metrics.

Based on the provided text, here's what can be extracted and inferred regarding acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

The document lists performance parameters that were measured, but does not provide specific quantitative acceptance criteria or the numerical results of these measurements.

Acceptance Criteria Category	Specific Acceptance Criteria (Not explicitly stated with numerical values)	Reported Device Performance (Not explicitly stated with numerical values)
Performance Parameters	The device should demonstrate acceptable levels of:	"The following performance parameters have been measured: Reproducibility, Repeatability, Signal-to-noise ratio (SNR)"
Reproducibility	(Implied: High reproducibility)	(Measurement conducted, but specific metrics not provided)
Repeatability	(Implied: High repeatability)	(Measurement conducted, but specific metrics not provided)
Signal-to-Noise Ratio (SNR)	(Implied: Adequate SNR for clinical interpretation)	(Measurement conducted, but specific metrics not provided)
Safety Parameters	The device should demonstrate acceptable levels of:	"The following safety parameters have been measured: Acoustic noise, dB/dt, SAR"
Acoustic Noise	(Implied: Within acceptable limits)	(Measurement conducted, but specific metrics not provided)
dB/dt	(Implied: Within acceptable limits)	(Measurement conducted, but specific metrics not provided)
SAR (Specific Absorption Rate)	(Implied: Within acceptable limits)	(Measurement conducted, but specific metrics not provided)
Clinical Evaluation	(Implied: Images generated by 3D ASL are useful for determining a diagnosis when interpreted by a trained physician, and the technique is comparable to predicate devices.)	"The following clinical testing has been performed to validate the 3D ASL technique: Clinical evaluation, Volunteer imaging"

Study that proves the device meets acceptance criteria:

The document states: "The following clinical testing has been performed to validate the 3D ASL technique: Clinical evaluation, Volunteer imaging." It concludes that "GE Healthcare considers the 3D ASL to be as safe, as effective, and performance is substantially equivalent to the predicate device(s)." This implies that the clinical evaluation and volunteer imaging demonstrated performance comparable to the predicate devices and met the implicit (but not explicitly detailed) acceptance criteria for safety and effectiveness.

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

Sample size for the test set: Not explicitly stated in the provided document. The mention of "Volunteer imaging" suggests healthy volunteers were part of the study, and "Clinical evaluation" would involve patient data, but specific numbers are absent.
Data provenance: Not explicitly stated. The document does not mention the country of origin of the data or whether it was retrospective or prospective.

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

This information is not provided in the document. While it states that images are "interpreted by a trained physician," it does not specify how many physicians were involved in establishing ground truth for the study, nor their specific qualifications.

4. Adjudication method for the test set:

This information is not provided in the document.

5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:

MRMC study: The document does not describe a multi-reader, multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance. The 3D ASL is described as a software option for generating perfusion maps, which are then interpreted by a trained physician, suggesting it is an imaging technique rather than an AI-assisted diagnostic tool that directly impacts reader performance in the manner of an MRMC study setup.
Effect size: Not applicable, as an MRMC study of this nature is not described.

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

The device (3D ASL) itself is essentially a standalone algorithm for generating specific image types (blood flow maps). It operates without human-in-the-loop performance during the image generation process. The output (the maps) then requires interpretation by a human. The "Performance parameters" listed (Reproducibility, Repeatability, SNR) would have been measured on the output of this standalone algorithm.

7. The type of ground truth used:

The exact "type of ground truth" (e.g., pathology, outcomes data) for the clinical evaluation is not specified. However, for a perfusion imaging technique, ground truth might involve comparisons to other established perfusion measurement techniques or clinical outcomes related to cerebral blood flow. Given the context, general "clinical evaluation" and "volunteer imaging" likely referred to the ability of the 3D ASL images to consistently and accurately reflect expected physiological blood flow in volunteers and potentially known clinical conditions in patients.

8. The sample size for the training set:

The document does not mention a "training set" or its sample size. This suggests the 3D ASL is likely a physics-based image reconstruction and processing algorithm rather than a machine learning model that requires explicit training data in the modern sense. Its development would be based on underlying physical principles and signal processing, validated with various datasets during development and verification.

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

Not applicable, as a training set for a machine learning model is not mentioned.

Summary

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Image /page/0/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circular border. The design is simple and recognizable, representing the company's brand identity.

'JAN - 6 2010

510(k) Summary

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

Date: 09/18/2009 Submitter: GE Healthcare, (GE Medical Systems, LLC) 3200 N. Grandview Blvd. Waukesha, WI 53188 USA Yuan Ma Person: Regulatory Affairs Leader GE Healthcare 3200 N Grandview Blvd., Mail Code: W-828 Waukesha, WI-53188 USA Phone: 262 521 6223 Fax: 414 908 9390 Glen Sabin Regulatory Affairs Manager GE Healthcare (GE Medical Systems, LLC.) Establishment Registration Number: 2183553 3200 N Grandview Blvd., Mail Code - W-827 Waukesha, WI-53188 USA. Phone: 262-521-6848

Primary Contact

Secondary Contact Person:

Regulatory Affairs Manager
GE Healthcare (GE Medical Systems, LLC.)
Establishment Registration Number: 2183553
3200 N Grandview Blvd., Mail Code - W-827
Waukesha, WI - 53188
USA
Phone: 262-521-6848

Device: Trade Name:	3DASL
Common/Usual Name:	3D ASL
Classification Names:	21 CFR
Product Code:	90-LNH

K083147, Discovery MR450 (GE Medical Systems, LLC) Predicate Device(s):

892.1000

Device Description:

K072237, MAGNETOM Verio (Siemens AG)

GE 3D ASL is an integration of a novel pulsed-continuous labeling technique and a 3D fast spin echo (FSE) acquisition.

Section 5 - 510(k) Summary

3D ASL Traditional 510(k)

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3D ASL 510(k) Premarket Notification

Image /page/1/Picture/2 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 logo is black and white and appears to be a vintage or historical version of the GE logo. The image quality is somewhat grainy, suggesting it may be a scan or a reproduction of an older image.

Intended Use:

3D ASL is a software option intended for use on GE 1.5T and 3.0T MR systems. It is indicated for magnetic resonance imaging of the brain.

When interpreted by a trained physician, images generated by 3D ASL provide information that can be useful in determining a diagnosis.

Technology:

3D ASL uses pulsed continuous labeling method to achieve the effects of continuous labeling. A train of very short RF pulses is used to obtain inversion (label) of blood spins. The amplitude and phase of the RF pulses are adjusted to achieve the labeling. In addition multiple selective and non-selective inversion pulses are employed to obtain static tissue suppression (aka background suppression). This allows for limited motion insensitivity as well as higher dynamic range for the perfusion images. 3DFSE with spiral readout is used for acquisition, combining the robustness of 3DFSE method and inherent oversampling nature of spiral trajectory. 3D ASL employs the same fundamental scientific technology as its predicate devices.

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K092925
page 3/3

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GE Healthcare

3D ASL: 510(k) Premarket Notification

Determination of Substantial Equivalence:

Summary of Testing:

The 3D ASL application complies with voluntary standards as detailed in Section 9 of this premarket submission. The following quality assurance measures were applied to the development of the application:

Risk Analysis

Requirements Reviews

Design Reviews

Design Verification

Design Validation

The following safety parameters have been measured:

Acoustic noise

dB/dt

SAR

The following performance parameters have been measured:

Reproducibility

Repeatability

Signal-to-noise ratio (SNR)

The following clinical testing has been performed to validate the 3D ASL technique:

Clinical evaluation

Volunteer imaging

Conclusion:

GE Healthcare considers the 3D ASL to be as safe, as effective, and performance is substantially equivalent to the predicate device(s).

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Public Health Service

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

Mr. Yuan Ma Regulatory Affairs Leader, MR Modality GE Medical Systems LLC 3200 N. Grandview Blvd. WAUKESHA WI 53188

JAN - 3 2010

Re: K092925

Trade/Device Name: 3D ASL Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: December 11, 2009 Received: December 14, 2009

Dear Mr. Ma:

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.

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 of medical

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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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Janine M. Morris

Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K U42725

Image /page/5/Picture/1 description: The image shows a black and white logo of General Electric (GE). The logo consists of the letters 'GE' intertwined within a circular border. The image quality is somewhat degraded, giving the logo a slightly distressed or vintage appearance.

GE Healthcare 3D ASL 510(k) Premarket Notification

510(k) Number (if known): K092925

Device Name: 3D ASL

Indications for Use:

3D ASL is a software option intended for use on GE 1.5T and 3.0T MR systems. It is indicated for magnetic resonance imaging of the brain.

When interpreted by a trained physician, images generated by 3D ASL provide information that can be useful in determining a diagnosis.

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

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Helent Reen

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number

Section 4 - Indications for Use Statement

3D ASL Traditional 510(k)

4-2 of 2

Regulation Number and Section

§ 892.1000 Magnetic resonance diagnostic device.

(a)
Identification. A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).(b)
Classification. Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.