MAVRIC SL is a combination of an acquisition technique and post-processing software intended for use on GE 1.5T and 3.0T MR systems. MAVRIC SL is suitable for use on all patients with passive MR Conditional orthopedics implants that are scanned according to the conditions of safe use for the specific MR Conditional implant being scanned. In addition, MAVRIC SL is suitable for use on patients without implants that are cleared for MR exams.

When interpreted by a trained physician, images generated by MAVRIC SL provide information that can be useful in determining a diagnosis.

Device Description

MAVRIC SL is a software application offered as an option for GE MR scanners. MAVRIC SL is based upon conventional 2D-FSE and then adds view-angle-tilting and additional phase-encoding in the slice-selective dimension. As a result, MAVRIC SL has reduced image artifacts and provides adequate spectral coverage in the presence of metal implants.

MAVRIC SL is a combination of an acquisition technique and post-processing software intended for use on GE 1.5T and 3.0T MR systems. MAVRIC SL is suitable for use on all patients cleared for MR exams.

When interpreted by a trained physician, images generated by MAVRIC SL provide information that can be useful in determining a diagnosis.

MAVRIC SL is an FSE-based, 3D Multi-Spectral Imaging technique. Individually encoded spectral images in the MAVRIC SL technique overlap in the frequency domain and together span a wide spectrum of spins located near metal implants. MAVRIC SL generates a final image by combining the individually encoded spectral images in a post-processing step. MAVRIC SL software option employs the same fundamental scientific technology as its predicate device.

AI/ML Overview

The provided text is a 510(k) Premarket Notification Submission for GE Healthcare's MAVRIC SL. It details the device, its intended use, and a summary of non-clinical and clinical tests. However, it does not contain the specific acceptance criteria or the detailed study results that directly prove the device meets these criteria. The document states that "The following clinical testing has been performed to validate the MAVRIC SL technique: Application validation, Clinical imaging," and concludes that "GE Healthcare considers the MAVRIC SL software option to be as safe, as effective, and performance is substantially equivalent to the predicate device." This suggests that a study was conducted, but the specifics of that study (like metrics, sample sizes, ground truth establishment, or expert details) are not included in the provided excerpt.

Therefore, many of the requested details cannot be extracted from this document.

Here's an attempt to answer the questions based on the available information, noting where information is missing:

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

Acceptance Criteria	Reported Device Performance
Not specified in the provided text.	MAVRIC SL helps reduce artifacts caused by presence of metal in both in-plane and through-plane dimensions compared to conventional MR imaging techniques. Thus MAVRIC SL allows visualizing more tissue in the vicinity of MR Conditional implanted metal instrumentation. When interpreted by a trained physician, images generated by MAVRIC SL provide information that can be useful in determining a diagnosis.

Acceptance Criteria

Reported Device Performance

Not specified in the provided text.

MAVRIC SL helps reduce artifacts caused by presence of metal in both in-plane and through-plane dimensions compared to conventional MR imaging techniques. Thus MAVRIC SL allows visualizing more tissue in the vicinity of MR Conditional implanted metal instrumentation. When interpreted by a trained physician, images generated by MAVRIC SL provide information that can be useful in determining a diagnosis.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not specified in the provided text.
Data Provenance: Not specified in the provided text.
Retrospective/Prospective: Not specified in the provided text.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Number of Experts: Not specified. The document mentions "interpreted by a trained physician," but does not detail the experts involved in establishing ground truth for testing.
Qualifications of Experts: Not specified.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Adjudication Method: Not specified in the provided text.

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 document implies clinical imaging was done for validation, but it does not explicitly state that an MRMC comparative effectiveness study was performed, nor does it provide any effect size related to human readers improving with or without AI assistance. The device is a "software option for Magnetic Resonance Imaging System" and is described as "an acquisition technique and post-processing software," not an AI-assisted diagnostic tool in the sense of providing specific interpretations or aiding human readers in decision-making beyond image quality improvement.

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

The MAVRIC SL is described as an imaging technique and post-processing software that generates images for interpretation by a physician. It is not presented as a standalone diagnostic algorithm. Its performance is intrinsically linked to the image generation and subsequent human interpretation. The text states: "When interpreted by a trained physician, images generated by MAVRIC SL provide information that can be useful in determining a diagnosis."

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Type of Ground Truth: Not specified in the provided text.

8. The sample size for the training set

Sample Size for Training Set: The document does not mention a distinct "training set" in the context of an algorithm or machine learning model. MAVRIC SL is described as an "acquisition technique and post-processing software," implying physics-based image reconstruction rather than a trainable AI model in the modern sense. Therefore, this question is likely not applicable to the description provided.

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

How Ground Truth for Training Set was Established: Not applicable, as no training set for a machine learning model is mentioned.

Summary

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K113394

GE Healthcare

510(k) Premarket Notification Submission

510(k) Summary

DEC 1 1 2012

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

November 09, 2011 .. Date:

Submitter:

GE Healthcare (GE Medical Systems, LLC 3200 N. Grandview Blvd. Waukesha, WI 53188 USA

Primary Contact Person:

Yuan Ma Regulatory Affairs Leader GE Healthcare (GE Medical Systems, LLC (262) 521-6223 (414) 908-9390fax

Secondary Contact Person:

Glen Sabin Regulatory Affairs Director GE Healthcare (GE Medical Systems, LLC (262) 521-6848 (262) 521-6439 fax

MAVRIC SL Trade Name: Device: Common/Usual Name:

. . .

Software Option for Magnetic Resonance Imaging System

Classification Names: 21 C.F.R. 892.1000 Magnetic Resonance Diagnostic Device

LNH Product Code:

Predicate Device(s):

PROPELLER Imaging Option for MRI, K031230

Device Description:

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Image /page/1/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 letters and the border are in black, creating a strong contrast against the white background.

GE Healthcare

510(k) Premarket Notification Submission

When interpreted by a trained physician, images generated by MAVRIC SL provide information that can be useful in determining a diagnosis.

Imaging technique. Individually encoded spectral images in the MAVRIC SL technique overlap in the frequency

MAVRIC SL is an FSE-based, 3D Multi-Spectral

Technology:

Intended Use:

final image by
spectral image
MAVRIC SL :
fundamental se

Determination of Substantial Equivalence:

domain and together span a wide spectrum of spins located near metal implants. MAVRIC SL generates a final image by combining the individually encoded spectral images in a post-processing step. MAVRIC SL software option employs the same

fundamental scientific technology as its predicate device.

Summary of Non-Clinical Tests:

The MAVRIC SL software option complies with voluntary standards as detailed in Section 9, 11, 16 and 18 of this premarket submission. The following quality assurance measures were applied to the development of the system:

Risk Analysis
Requirements Reviews
Design Reviews .
Design Verification
Safety Testing

The following safety parameters were measured:

Acoustic Noise
dB/dt >
SAR

The non-clinical tests outlined above have been executed with acceptable results. Refer to Sections 9, 16, and 18 of this submission for testing results.

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GE Healthcare

: : :

:: : : :

:: 1.:

: : :

. . . .

:: : :

4 of 4

510(k) Premarket Notification Submission

Summary of Clinical Tests:

The following clinical testing has been performed to validate the MAVRIC SL technique:

: : : .

Application validation く
Clinical imaging .

Conclusion:

GE Healthcare considers the MAVRIC SL software option to be as safe, as effective, and performance is substantially equivalent to the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized graphic of an abstract human figure with outstretched arms, accompanied by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the graphic. The text is in all caps and is evenly spaced around the circle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

December 11, 2012

GE Medical System, LLC C/O Mr. Yuan Ma Regualtory Affairs Leader, MR 3200 N. Grandview Blvd. W-828 WAUKESHA. WI 53188

Re: K113394

Trade/Device Name: MAVRIC SL Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: November 8, 2012 Received: November 9, 2012

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. 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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Page 2-Mr. Ma

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 -S

Janine M. Morris 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): K113394

Device Name: MAVRIC SL

Indications for Use:

When interpreted by a trained physician, images generated by MAVRIC SL provide information that can be useful in determining a diagnosis.

Prescription Use X

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

Janine M. Morris -5 2012.12.12 08:02:20 -05'00' (Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health

K113394 510(k)

Page 1 of

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.