The MAGNETOM systems are indicated for use as magnetic resonance diagnostic devices (MRDD) that produce transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and or spectra, and that display the internal structure and/or function of the head, body or extremities.

Other physical parameters derived from the images and/or spectra may also be produced. Depending on the region of interest, contrast agents may be used. These images and the physical parameters derived from the inages and/or spectra when interpreted by a trained physician, yield information that may assist in diagnosis.

The MAGNETOM systems described above may also be used for imaging during interventional procedures when performed with MR compatible devices such as in-room display and MR-Safe biopsy needles.

Device Description

The subject device, synqo MR E11B system software, is being made available for the following MAGNETOM MR Systems:

MAGNETOM Aera (24-channel configuration), .
MAGNETOM Avanto™ ●
MAGNETOM Skyra™, ●
. MAGNETOM Prisma and
. MAGNETOM Prisma™

Two new coils, Body 30/60 and Body 6 long, will be available for the subject device systems. The feature FREEZEit will be extended to other body regions. In addition to the abdomen region, FREEZEit will be extended to other regions such as the head, head and neck, pelvis, and chest region. . The syngo MR E11B SW also includes new sequences as well as minor modifications of already existing features. A high level summary of the new sequences can be viewed below:

DSI
With software version syngo MR E11B Siemens offers DSI for MAGNETOM Prisma, Prismall and Skyra" systems. The DSI option allows diffusion-weighted images to be acquired according to a DSI-compatible q-space sampling scheme.

QISS evaluation
QISS (Quiescent-Interval Single-Shot) MR Angiography is a technique for non-contrastenhanced MR Angiography (non-CEMRA) that is particularly suited for examinations of patients with PAD. Since patients with PAD may also suffer from additional impairments such as renal dysfunction, the administration of contrast agent may often be unadvisable in this patient group. Siemens provides a manageable and optimized QISS workflow for imaging peripheral arteries, which can be easily adapted by the customer based on the patient's needs.

A new "Dot Engine" is provided to ease MRI acquisitions in Radiation Therapy.

RT Dot Engine
RT Dot Engine is a new Dot Engine for aiding in Radiation Therapy planning. The RT Dot Engine does not provide new functionality, but collects and displays existing system information for the user. The RT Dot Engine comprises existing protocols, enhanced with the RT Planning Dot Add-in and the "MPR Planning" interaction step. The RT (Radiation Therapy) Dot Engine is used to ease MRI acquisitions of the head and the head/neck region with stereotactic frames or mask-based fixation techniques. RT Dot Engine is a workflow solution for acquiring MR images intended to aid in Radiation Therapy Planning. RT Dot engine helps streamline acquisition of MR images to be used along with any RT planning software that uses MR images in addition to CT images.

AI/ML Overview

The provided text is a 510(k) summary for a medical device and does not contain the level of detail typically found in a clinical study report regarding acceptance criteria and performance studies for an AI-powered device.

This document describes a Magnetic Resonance Diagnostic Device (MRDD) software upgrade (syngo MR E11B) for existing Siemens MAGNETOM MR systems. The submission is a 510(k) premarket notification, which seeks to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving performance against specific acceptance criteria for a novel AI algorithm.

Therefore, many of the requested details about acceptance criteria, clinical study design, sample sizes, ground truth establishment, and expert adjudication are not present in this type of regulatory document.

However, I can extract the information that is available and clarify what is missing based on the context of a 510(k) submission for an MRI system software upgrade:

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

Acceptance Criteria	Reported Device Performance (Summary)
Safety and Effectiveness	The device performs as intended and is substantially equivalent to predicate devices. Risk management followed ISO 14971:2007. Adherence to IEC 60601-1 series to minimize electrical and mechanical risk. Conforms to applicable FDA recognized and international IEC, ISO, and NEMA standards.
Technological Characteristics	Same technological characteristics as predicate device systems (K141977). Substantially equivalent in acquiring MR images steps/features, operational environment, programming language, operating system, and performance. Conforms to IEC 62304:2006 for software medical devices and IEC/NEMA standards.
New Coils (Body 30/60, Body 6 long)	Coils tested for SNR, image uniformity, and heating. Clinical images provided to support new coils.
New/Modified Sequences & Algorithms	Dedicated phantom testing conducted for particular new sequences (e.g., DSI, QISS, RT Dot Engine). Acoustic noise measurements performed for quiet sequences. Image quality assessments completed; comparisons made to predicate features where applicable. Clinical images provided to support new software features.

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 explicitly stated as a formal "test set" in the context of an algorithm evaluation. The document mentions "clinical images were provided to support the new coils as well as the new software features," but the number of images or patients is not specified.
Data Provenance: Not specified. Given the nature of a 510(k) for a software upgrade to an MRI machine, the "clinical images" likely came from internal testing or routine clinical acquisitions.

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)

The document states "These images and the physical parameters derived from the images and/or spectra when interpreted by a trained physician, yield information that may assist in diagnosis." However, it does not specify the number or qualifications of experts used to establish a formal ground truth for testing the software's performance, as this is an MRI system software upgrade, not a diagnostic AI algorithm.

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

No adjudication method is mentioned.

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 study was conducted or reported. This device is a software upgrade for an MRI system, not an AI diagnostic assistant tool.

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

Not applicable in the context of this device. The software "produces transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and or spectra," which are then "interpreted by a trained physician." It is not a standalone diagnostic algorithm.

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

For the nonclinical tests (SNR, uniformity, heating, acoustic noise), the "ground truth" would be established by technical specifications and phantom measurements.
For image quality assessments, a "ground truth" (e.g., against specific diagnostic findings) is not detailed. The assessment likely involved expert review of image quality (e.g., resolution, artifact reduction, diagnostic clarity) rather than a comparison to a definitive clinical ground truth established by pathology or long-term outcomes. The primary focus is on demonstrating that the images produced are diagnostically acceptable and equivalent to the predicate.

8. The sample size for the training set

Not applicable. This document describes a software upgrade for an MRI system, which includes new sequences and features (e.g., DSI, QISS, RT Dot Engine). It is not an AI algorithm that would typically have a "training set" in the machine learning sense. The software development follows traditional engineering and quality assurance practices.

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

Not applicable, as no training set (in the AI/ML context) is mentioned for this device.

Summary

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

September 29, 2015

Siemens Medical Solutions USA, Inc. % Cordell Fields, Esq. Regulatory Affairs Specialist 51 Valley Stream Parkway MALVERN PA 19355

Re: K151579

Trade/Device Name: MAGNETOM Aera (24-channel). MAGNETOM Ayantofit. MAGNETOM Skyrafit, MAGNETOM Prisma/ Prismafit Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH, LNI, MOS Dated: August 28, 2015 Received: August 31, 2015

Dear Mr. Fields:

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K151579

Device Name

MAGNETOM Aera (24-channel), MAGNETOM Avantofit, MAGNETOM Skyrafit, MAGNETOM Prisma Prismafit

Indications for Use (Describe)

The MAGNETOM systems described above may also be used for imaging during interventional procedures when performed with MR compatible devices such as in-room display and MR-Safe biopsy needles.

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."

FORM FDA 3881 (8/14)

Page 1 of 1

PSC Publishing Services (301) 443-6740 EEF

Siemens 510(k) Premarket Notification

June 9, 2015

Syngo MR E11B for MAGNETOM Aera (24) (1.5T), MAGNETOM Avanto fit (1.5T), MAGNETOM Skyra fit (3T) and MAGNETOM Prisma/Prisma fit (3T)

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Section 5 510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of Safe Medical Device Act 1990 and 21 CFR § 807.92.

I. General Information

Establishment	Siemens Medical Solutions USA. Inc.65 Valley Stream ParkwayMail Code 65-1AMalvern, PA 19355, USA
Registration Number	2240869
Date Prepared	June 9, 2015
Manufacturer	Siemens AGHenkestrasse 127D-91052 Erlangen, GermanyRegistration Number: 002808157
	SIEMENS SHENZHEN MAGNETIC RESONANCE LTD.Siemens MRI CenterHi-Tech Industrial park (middle)Gaoxin C. Ave., 2ndShenzhen 518057, P.R. CHINARegistration Number: 3004754211

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Section 5: 510(k) Summary

Contact Person Mr. Cordell L. Fields, Esq. Regulatory Affairs Specialist Siemens Healthcare Siemens Medical Solutions USA, Inc. Customer Solutions Group 51 Valley Stream Parkway Malvern, PA 19355, USA Phone: (610) 448-8518 Fax: (610) 448-1787
Syngo MR E11 for MAGNETOM Aera (24) (1.5T), MAGNETOM Device Name Avantoff (1.5T), MAGNETOM Skyra™ (3T) and MAGNETOM Prisma/Prismatit (3T)
Trade Names:

MAGNETOM Aera MAGNETOM Skyra™ MAGNETOM Avanto™ MAGNETOM Prisma MAGNETOM Prisma™

Classification Name:	Magnetic Resonance Diagnostic Device (MRDD
Classification Panel:	Radiology
CFR Code:	21 CFR § 892.1000
Classification:	Class II
Product Code:	Primary: LNH, Secondary: LNI, MOS

Siemens 510(k) Premarket Notification

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II. Safety and Effectiveness Information Supporting Substantial Equivalence

Intended Use

The MAGNETOM systems [MAGNETOM Aera, MAGNETOM Skyra", MAGNETOM Avanto", MAGNETOM Prisma and MAGNETOM Prisma""] are indicated for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and/or spectra, and that displays the internal structure and/or function of the head, body, or extremities.

Other physical parameters derived from the images and/or spectra may also be produced. Depending on the region of interest, contrast agents may be used. These images and/or spectra and the physical parameters derived from the images and/or spectra, when interpreted by a trained physician, yield information that may assist in diagnosis.

The MAGNETOM systems may also be used for imaging during interventional procedures when performed with MR compatible devices such as in-room display and MR-Safe biopsy needles.

Device Description

The subject device, synqo MR E11B system software, is being made available for the following MAGNETOM MR Systems:

MAGNETOM Aera (24-channel configuration), .
MAGNETOM Avanto™ ●
MAGNETOM Skyra™, ●
. MAGNETOM Prisma and
. MAGNETOM Prisma™

DSI

With software version syngo MR E11B Siemens offers DSI for MAGNETOM Prisma, Prismall and Skyra" systems. The DSI option allows diffusion-weighted images to be acquired according to a DSI-compatible q-space sampling scheme.

Siemens 510(k) Premarket Notification

Syngo MR E11B for MAGNETOM Aera (24) (1.5T), MAGNETOM Avanto fit (1.5T), MAGNETOM Skyra fit (3T) and MAGNETOM Prisma/Prisma fit (3T)

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DSI is based on sampling the "q-space", where "q-space" is defined in analogy to the "kspace" by the moment of the diffusion encoding gradients G: g = y/2π J G(t) dt.

While the Fourier transform of k-space data generates the image content, a Fourier transform of q-space data allows calculating a probability density function. This data provides information about the probability of a particle moving to a certain position in space within a certain time interval by diffusive motion.

The DSI Application is only available for MAGNETOM Prisma/Prisma™ and Skyraf" Systems.

QISS evaluation

QISS (Quiescent-Interval Single-Shot) MR Angiography is a technique for non-contrastenhanced MR Angiography (non-CEMRA) that is particularly suited for examinations of patients with PAD. Since patients with PAD may also suffer from additional impairments such as renal dysfunction, the administration of contrast agent may often be unadvisable in this patient group. Siemens provides a manageable and optimized QISS workflow for imaging peripheral arteries, which can be easily adapted by the customer based on the patient's needs.

A new "Dot Engine" is provided to ease MRI acquisitions in Radiation Therapy.

RT Dot Engine

RT Dot Engine is a new Dot Engine for aiding in Radiation Therapy planning. The RT Dot Engine does not provide new functionality, but collects and displays existing system information for the user. The RT Dot Engine comprises existing protocols, enhanced with the RT Planning Dot Add-in and the "MPR Planning" interaction step. The RT (Radiation Therapy) Dot Engine is used to ease MRI acquisitions of the head and the head/neck region with stereotactic frames or mask-based fixation techniques. RT Dot Engine is a workflow solution for acquiring MR images intended to aid in Radiation Therapy Planning. RT Dot engine helps streamline acquisition of MR images to be used along with any RT planning software that uses MR images in addition to CT images.

Technological Characteristics

SW syngo MR E11B for MAGNETOM Aera (24-channel configuration), MAGNETOM Avanto®, MAGNETOM Skyra™, MAGNETOM Prisma and MAGNETOM Prisma™ has the same technological characteristics as the predicate device systems (K141977; cleared November 19, 2014).

Siemens 510(k) Premarket Notification

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SW syngo MR E11B for MAGNETOM Aera (24-channel configuration), MAGNETOM Avanto®, MAGNETOM Skyra™, MAGNETOM Prisma and MAGNETOM Prisma™ is substantially equivalent with regard to acquiring MR images steps/features.

The syngo MR E11B for MAGNETOM Aera (24-channel configuration), MAGNETOM Avantoff, MAGNETOM Skyra™, MAGNETOM Prisma and MAGNETOM Prismat" is substantially equivalent with regard to operational environment, programming language, operating system and performance.

synqo MR E11 for MAGNETOM Aera (24-channel configuration), MAGNETOM Avanto™, MAGNETOM Skyra™, MAGNETOM Prisma and MAGNETOM Prisma"", conform to the standard for software medical devices (IEC 62304:2006) and IEC as well as NEMA standards.

While syngo MR E11B offers additional capabilities with respect to the predicate device systems, the syngo MR E11B software on the subject device MR Systems has the same technological characteristics as the predicate device systems (K141977; cleared November 19, 2014).

Nonclinical Tests

The following performance testing was conducted on syngo MR E11B SW subject device:

The coils were tested for SNR, image uniformity, and heating.
Dedicated phantom testing was conducted on particular new sequences. ●
Acoustic noise measurements were performed for quiet sequences
. lmage quality assessments of all new/modified sequences and algorithms, were completed. In some cases a comparison of the image quality was made between the new/modified features and the predicate features.

The results from each set of tests demonstrate that the device performs as intended and is thus substantially equivalent to the predicate devices to which it has been compared.

Clinical Tests

No clinical tests were conducted to support the subject device and the substantial equivalence argument; however, clinical images were provided to support the new coils as well as the new software features of the subject device.

Safety and Effectiveness

Siemens 510(k) Premarket Notification

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SIEMENS

The device labeling contains instructions for use and any necessary cautions and warnings, to provide for safe and effective use of the device.

Risk management is ensured via a risk analysis in compliance with ISO 14971:2007 to identify and provide mitigation to potential hazards in a risk analysis beginning early in the design phase and continuing throughout the development of the product. These risks are controlled via measures realized in software development. SW testing and product labeling. To minimize risks, Siemens adheres to recognized and established industry practices and standards, such as the IEC 60601-1 series, to minimize electrical and mechanical risk. Furthermore, the operators are healthcare professionals familiar with and responsible for the acquisition and post processing of magnetic resonance images.

The syngo MR E11B for MAGNETOM Aera (24-channel configuration), MAGNETOM Avanto", MAGNETOM Skyra", MAGNETOM Prisma and MAGNETOM Prisma" conform to the applicable FDA recognized and international IEC, ISO and NEMA standards with regards to performance and safety as recommended by the respective MR FDA Guidance Document.

Substantial Equivalence

synqo MR E11B for MAGNETOM Aera (24-channel configuration), MAGNETOM Avanto", MAGNETOM Skyra", MAGNETOM Prisma and MAGNETOM Prisma" includes all of the features of the predicate device, systems MAGNETOM Aera and MAGNETOM Skyra with syngo MR E11A.

Predicate Device Information

Predicate Device Name	FDA ClearanceNumber and Date	Productcode	Manufacturer
syngo MR E11A for theMAGNETOM systemsAera/Skyra	K141977, clearedNovember 19, 2014	LNHLNI,MOS	SiemensHealthcareGmbH

Reference Device Information

Reference Device Name	FDA ClearanceNumber andDate	Productcode	Manufacturer
MAGNETOM Aera with syngoMR D13E	K132951 cleared at15 November,2013	PrimaryLNH	SiemensHealthcareGmbH

Siemens 510(k) Premarket Notification

June 9, 2015

Syngo MR E11B for MAGNETOM Aera (24) (1.5T), MAGNETOM Avanto fit (1.5T), MAGNETOM Skyra fit (3T) and MAGNETOM Prisma/Prisma fit (3T)

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Reference Device Name	FDA ClearanceNumber andDate	Productcode	Manufacturer
MAGNETOM Avantofit andMAGNETOM Skyrafit	K130885 cleared at17 May, 2013	PrimaryLNH	SiemensHealthcareGmbH
MAGNETOM Prisma andMAGNETOM Prismafit	K132119 cleared at22 November,2013	PrimaryLNH	SiemensHealthcareGmbH

Conclusion as to Substantial Equivalence

synqo MR E11B for MAGNETOM Aera (24-channel configuration), MAGNETOM Avanto®", MAGNETOM Skyra®, MAGNETOM Prisma and MAGNETOM Prisma™ has the same intended use and the same basic technological characteristics as the predicate device, systems MAGNETOM Aera and MAGNETOM Skyra with syngo MR E11A, with respect to the magnetic resonance features and functionalities.

MAGNETOM Aera (24-channel configuration), MAGNETOM Avanto", MAGNETOM Skyra™, MAGNETOM Prisma and MAGNETOM Prisma™ with software syngo MR E11B will be used for acquiring MR images (transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and/or spectra.)

The differences between the MR systems with the subject device software and the predicate device SW, including the aforementioned new software and hardware options, give the subject device the same capabilities as the predicate device systems. While there are some minor technical features that vary with respect to the predicate device MR Systems, the conclusions from the non-clinical data suggest that the features with different technological characteristics from the predicate device bear an equivalent safety and performance profile as that of the predicate and reference devices.

syngo MR E11B for MAGNETOM Aera (24-channel configuration), MAGNETOM Avanto fit, MAGNETOM Skyra fit, MAGNETOM Prisma and MAGNETOM Prisma" is similar to the functionalities of the predicate device, and does not introduce any new issues of safety or effectiveness.

Therefore, Siemens is of the opinion that syngo MR E11 for MAGNETOM Aera (24channel configuration), MAGNETOM Avanto(4, MAGNETOM Skyra(*, MAGNETOM Prisma and MAGNETOM Prisma™ does not raise new questions of safety or effectiveness and is substantially equivalent to the currently marketed device

Siemens 510(k) Premarket Notification

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MAGNETOM Aera/ Skyra with software syngo MR E11A (K141977 cleared on November 19, 2014).

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.