The uMR 780 system is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces sagittal, transverse, coronal, and oblique cross sectional images, and that display internal anatomical structure and/or function of the head, body and extremities.

These images and the physical parameters derived from the interpreted by a trained physician yield information that may assist the diagnosis. Contrast agents may be used depending on the region of interest of the scan.

Device Description

The uMR 780 is a 3.0T superconducting magnetic resonance diagnostic device with a 65cm size patient bore. It consists of components such as magnet, RF power amplifier, RF coils, gradient power amplifier, gradient coils, patient table, spectrometer, computer, equipment cabinets, power distribution system, internal communication system, and vital signal module etc. The uMR 780 Magnetic Resonance Diagnostic Device is designed to conform to NEMA and DICOM standards.

AI/ML Overview

The provided text does not contain detailed acceptance criteria for a medical device's performance, nor does it describe a study specifically designed to "prove the device meets the acceptance criteria" in terms of clinical efficacy or diagnostic accuracy. Instead, it focuses on demonstrating substantial equivalence to a predicate device for regulatory clearance.

Here's an analysis of the provided information based on your requested points:

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

The document lists several NEMA MS standards that the uMR 780 conforms to, which implicitly define performance criteria. However, it does not explicitly state acceptance criteria in a quantitative form (e.g., "SNR must be > X dB") nor does it present the specific numerical results obtained for each of these performance metrics. It only states: "The test results demonstrated that the device performs as expected and thus, it is substantially equivalent to the predicate devices to which it has been compared."

Therefore, a table cannot be constructed with the provided information.

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

The document mentions:

"A volunteer study was used to determine the safety limits associated with gradient-induced nerve stimulation."
"Sample clinical images were provided to support the ability of uMR 780 to A generate diagnostic quality images in accordance with the MR guidance on premarket notification submissions."
Sample size for gradient-induced nerve stimulation study: Not specified.
Sample size for diagnostic image quality study: Not specified (referred to as "Sample clinical images").
Data provenance: Not specified (e.g., country of origin, retrospective or prospective nature).

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)

This information is not provided. The diagnostic images were "interpreted by a trained physician," but the number of physicians, their qualifications, or the process for establishing ground truth from these images is not detailed.

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

This information is not provided.

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

No MRMC comparative effectiveness study is mentioned.
The device is a Magnetic Resonance Diagnostic Device (uMR 780), which is an imaging scanner, not an AI-assisted diagnostic tool for interpretation. Therefore, the question about human reader improvement with AI assistance is not applicable in this context.

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

A "standalone" study in the context of an algorithm's performance is not applicable to a physical imaging device like the uMR 780.
The document implies that the device itself (uMR 780) was tested for its performance metrics (NEMA standards, SNR, uniformity, geometric distortion, etc.) and for its ability to produce diagnostic quality images, which can be seen as standalone performance for the device's image acquisition capabilities.

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

For the "sample clinical images" used to support diagnostic quality, the ground truth is implicitly understood to be the interpretation by "a trained physician." However, the method for establishing a definitive "ground truth" (e.g., expert consensus, comparison to another gold standard like pathology, or follow-up outcomes) is not explicitly described.
For the NEMA standards testing, the "ground truth" is the established reference values or methods defined by those standards.

8. The sample size for the training set

The document does not describe any "training set" as it pertains to AI/machine learning algorithms. The uMR 780 is a hardware device for acquiring images.

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

Not applicable, as there is no mention of a training set for an AI/machine learning algorithm.

In summary:

This document is a 510(k) summary focused on demonstrating substantial equivalence for a new MRI scanner (uMR 780) to a predicate device (SIEMENS MAGNETOM SKYRA). It primarily relies on engineering and performance testing against industry standards (NEMA, IEC, ISO) and a volunteer safety study, along with providing "sample clinical images" to show diagnostic quality. It does not provide the detailed diagnostic performance studies (like sensitivity, specificity, accuracy against a clinical ground truth, or reader studies) that would typically be described for a diagnostic AI algorithm.

Summary

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

Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

Shanghai United Imaging Healthcare Co., Ltd. Xin GAO Regulatory Affairs Specialist No. 2258 Chengbei Rd., Jiading Industrial District SHANGHAI, CHINA 201807

Re: K181370

Trade/Device Name: uMR 780 Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: Class II Product Code: LNH Dated: May 21, 2018 Received: May 23, 2018

Dear Xin GAO:

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

October 3, 2018

{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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice

(https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Michael D. O'Hara

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

Enclosure

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

Indications for Use

510(k) Number (if known) K181370

Device Name uMR 780

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}------------------------------------------------

Image /page/3/Picture/1 description: The image contains the logo for United Imaging. The text "UNITED" is stacked on top of the text "IMAGING". To the right of the text is a stylized letter "U" that is dark teal in color. The logo is simple and modern.

510 (k) SUMMARY

K181370

1. Date Prepared [21 CFR 807.92(a)(1)] May 21, 2018

2. General Information [21 CFR 807.92(a)(1)]

Manufacturer:	Shanghai United Imaging Healthcare Co., Ltd2258 Chengbei Rd., Jiading District, Shanghai, 201807
Contact Person:	Xin GAO
	Regulatory Affairs Specialist
	Tel: +86 (21) 67076888-5386
	Fax: +86-021-67076889
	Email: xin.gao@united-imaging.com

3. Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)]

Trade Name:	uMR 780
Common Name:	Magnetic Resonance Diagnostic Device
Model:	uMR 780
Product Code:	LNH
Regulation Number:	892.1000
Device Class:	II

4. Identification of Predicate Devices(s) [21 CFR 807.92(a)(3)[

The identification of predicates device within this submission is as follow:

Predicate Device Manufacturer: SIEMENS AG Device Name: MAGNETOM SKYRA Product Code: LNH Device Class: II Regulation Number: 21 CFR 892.1000 FDA 510 (k) #: K123510

5. Device Description [21 CFR 807.92(a)(4)]

SECTION 7 - 2 of 4

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

Image /page/4/Picture/1 description: The image contains the logo for United Imaging. The logo consists of the words "UNITED IMAGING" in a bold, sans-serif font, stacked on top of each other. To the right of the text is a stylized "U" symbol, which is made up of two vertical lines connected by a curved base. The logo is simple and modern, and the use of a bold font and a strong symbol gives it a sense of authority and trustworthiness.

6. Intended Use [21 CFR 807.92(a)(5)]

The uMR 780 system is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces sagittal, transverse, coronal, and oblique cross sectional images, and spectroscopic images, and that display internal anatomical structure and/or function of the head, body and extremities.

These images and the physical parameters derived from the images when interpreted by a trained physician yield information that may assist the diagnosis. Contrast agents may be used depending on the region of interest of the scan.

7. Technological Characteristic [21 CFR 807.92(a)(6)]

The uMR 780 has the same major technological characteristics as the predicate device. The differences from the predicate device including high order shimming configuration, interventional usage, RFPA power and external triggering function are discussed in the comparison table in this submission. The same scientific technology theory, similar physical design, same coil applications and functionalities are applied to both the uMR 780 and predicate device. The technical characteristic differences do not affect the safety and effectiveness of the uMR 780 for intended use.

8. Substantial Equivalence [21 CFR 807.92(b)(1) and 807.92(b)(2)]

Summary of Non-Clinical Tests:

The following testing was conducted on the uMR 780 Magnetic Resonance Diagnostic Device as the predicate device:

A ES60601-1:2005/(R)2012, Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance
A IEC 60601-1-2 Edition 3.0 2007-03, Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Disturbances - Requirements And Tests
A 60601-2-33 Ed. 3.1:2013, Medical Electrical Equipment - Part 2-33: Particular Requirements For The Basic Safety And Essential Performance Of Magnetic Resonance Equipment For Medical Diagnostic
A IEC 60825-1 Edition 2.0 2007-03, Safety Of Laser Products - Part 1: Equipment Classification, And Requirements [Including: Technical Corrigendum 1 (2008),

SECTION 7 - 3 of 4

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

Image /page/5/Picture/1 description: The image contains the logo for United Imaging. The words "UNITED IMAGING" are stacked on top of each other in a bold, sans-serif font. To the right of the text is a stylized symbol that resembles a shield or a stylized letter U with a vertical line running through it. The logo has a modern and corporate feel.

Interpretation Sheet 1 (2007), Interpretation Sheet 2 (2007)]

ISO 10993-5 Third Edition 2009-06-01, Biological Evaluation Of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity
ISO 10993-10 Third Edition 2010-08-01, Biological Evaluation Of Medical A Devices - Part 10: Tests For Irritation And Skin Sensitization
MS 1-2008(R2014), Determination of Signal-to-Noise Ratio (SNR) in Diagnostic Magnetic Resonance Images
A MS 2-2008(R2014), Determination of Two-Dimensional Geometric Distortion in Diagnostic Magnetic Resonance Images
MS 3-2008(R2014), Determination of Image Uniformity in Diagnostic Magnetic Resonance Images
MS 4-2010, Acoustic Noise Measurement Procedure for Diagnosing Magnetic Resonance Imaging Devices
A MS 5-2010, Determination of Slice Thickness in Diagnostic Magnetic Resonance Imaging
A MS 6-2008(R2014), Determination of Signal-to-Noise Ratio and Image Uniformity for Single-Channel Non-Volume Coils in Diagnostic MR Imaging
MS 8-2008, Characterization Of The Specific Absorption Rate For Magnetic Resonance Imaging Systems
A MS 9-2008(R2014), Standards Publication Characterization of Phased Array Coils for Diagnostic Magnetic Resonance Images

The test results demonstrated that the device performs as expected and thus, it is substantially equivalent to the predicate devices to which it has been compared.

Summary of Clinical Tests:

A A volunteer study was used to determine the safety limits associated with gradient-induced nerve stimulation.
Sample clinical images were provided to support the ability of uMR 780 to A generate diagnostic quality images in accordance with the MR guidance on premarket notification submissions.

9. Conclusion [21 CFR 807.92(b)(3)]

In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification, we concludes that uMR 780 Magnetic Resonance Diagnostic Device is substantially equivalent to the predicate device. It does not introduce new indications for use, and has the same technological characteristics and does not introduce new potential hazards or safety risks.

SECTION 7 - 4 of 4

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.