The MAGNETOM SYMPHONY with the High End Gradients is a whole body scanner with higher gradient amplitudes. The MAGNETOM SYMPHONY with the High End Gradients is indicated for use as diagnostic imaging device to produce transversal, sagittal, coronal and oblique images of the internal structures of the head or body. The images produced by the MAGNETOM SYMPHONY with the High End Gradients reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin lattice relaxation time (T1), spin-spin relaxation time (T") and flow. When interpreted by a trained by a trained physician, these images provide information that can be useful in determining a diagnosis.

Device Description

The MAGNETOM SYMPHONY with the High End Gradients is a whole body scanner with higher gradient amplitudes.

AI/ML Overview

The provided text describes a 510(k) submission for "High End Gradients" for the MAGNETOM SYMPHONY system, which is a Magnetic Resonance Diagnostic Device. This submission primarily focuses on demonstrating substantial equivalence to a predicate device and ensuring safety and effectiveness, rather than reporting on a study designed to meet specific diagnostic accuracy acceptance criteria.

The acceptance criteria mentioned are related to safety and performance parameters of the MR system itself, not the diagnostic accuracy of a specific AI algorithm. The study described is a laboratory testing to support the claim of substantial equivalence and ensure the technological differences do not raise new safety or effectiveness concerns.

Therefore, many of the requested elements (like sample size for test set, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set details) are not applicable or
available from this document because it's not an AI/algorithm performance study.

Here's an attempt to answer the questions based on the provided text, indicating where information is not available or not applicable:

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

The document lists "safety parameters with action levels" and "performance levels" as evaluation criteria for the device (High End Gradients for MAGNETOM SYMPHONY). It explicitly states that "the new levels are not significantly changed and, in the case of safety, parameters remain below the level of concern as outlined by the FDA Guidance." However, the exact numerical acceptance criteria and reported performance values for each are not detailed in the provided text.

Acceptance Criteria Category	Specific Parameter	Acceptance Criteria (Not explicitly stated numerically, but implied as "below level of concern" or "not significantly changed")	Reported Device Performance (Not explicitly stated numerically, but implied as meeting criteria)
Safety Parameters	Maximum Static Field	Below level of concern as outlined by FDA Guidance	Met
	Rate of Change of Magnetic Field	Below level of concern as outlined by FDA Guidance	Met
	RF Power Deposition	Below level of concern as outlined by FDA Guidance	Met
	Acoustic Noise Levels	Below level of concern as outlined by FDA Guidance	Met
Performance Levels	Specification Volume	Not significantly changed from predicate	Met
	Signal to Noise	Not significantly changed from predicate	Met
	Image Uniformity	Not significantly changed from predicate	Met
	Geometric Distortion	Not significantly changed from predicate	Met
	Slice Profile, Thickness and Gap	Not significantly changed from predicate	Met
	High Contrast Spatial Resolution	Not significantly changed from predicate	Met

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

The document states "Laboratory testing were performed." It does not specify the sample size of any test sets (e.g., number of phantom scans, number of human subject scans) or the data provenance (e.g., country of origin, retrospective/prospective). This is a device modification submission, not a clinical study on diagnostic accuracy.

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)

Not applicable. The ground truth for this type of submission would relate to engineering measurements and adherence to technical specifications, not diagnostic interpretations by human experts in a clinical context.

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

Not applicable. This is not a study requiring adjudication of diagnostic findings. Adjudication would likely be part of the internal engineering and testing processes by qualified personnel.

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. This document does not detail an MRMC study. It describes a change to the hardware of an MRI system (High End Gradients) and assesses its impact on the system's safety and performance, demonstrating substantial equivalence to a predicate device. It does not involve AI assistance or human reader performance.

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

Not applicable. This submission is for MRI hardware (gradients), not a standalone algorithm.

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

The "ground truth" for this submission would be defined by established engineering and physics principles, such as standardized phantom measurements, calibrated sensors for field strength, RF power, acoustic levels, and image quality metrics. It is not related to clinical diagnostic ground truths like pathology or expert consensus.

8. The sample size for the training set

Not applicable. This is not a submission for an AI/ML algorithm that requires a training set.

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

Not applicable. There is no training set for an AI/ML algorithm in this submission.

Summary

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AUG = 3 1090

9/652

510 (k) Summary

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

I. General Information.

Establishment:

Siemens Medical Systems, Inc. . Address: 186 Wood Avenue South Iselin, N.J. 08830
Registration Number: 2240869
Mr. Jamie Yieh Contact Person: Technical Specialist, Regulatory Submissions (732) 321-4625 (732) 321-4841

5/12/99 Date of Summary Preparation:

Device Name:

High End Gradients • Trade Name:
Classification Name: Magnetic Resonance Diagnostic Device, CFR & 892.1000
Classification: Class II
· Performance Standards:

None established under Section 514 the Food, Drug, and Cosmetic Act.

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II. Safety and Effectiveness Information Supporting Substantial Equivalence.

• Device Description:

· Intended Use

· Technological Characteristics

The MAGNETOM Symphony with the new High End Gradients is substantially equivalent to the MAGNETOM Symphony System.

· General Safety and Effectiveness Concerns:

Operation of the MAGNETOM Symphony with the new High End Gradients is substantially equivalent to the commercially available MAGNETOM Symphony System. The following safety parameters with action levels:

Maximum Static Field
. Rate of Change of Magnetic Field
. RF Power Deposition
. Acoustic Noise Levels

and performance levels

●

Specification Volume .
. Signal to Noise
. Image Uniformity
. Geometric Distortion
Slice Profile, Thickness and Gap •
. High Contrast Spatial Resolution

specified by the FDA guidance document for MR Diagnostic Devices were evaluated within this notification. The reduction in the minimum rise time of the system will affect both the acoustic noise levels and the rate of change of magnetic field strength (dB/dt), as well as certain performance levels with the system. However, the new levels are not significantly changed and, in the case of safety, parameters remain below the level of concern as outlined by the FDA Guidance.

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• Substantial Equivalence:

Laboratory testing were performed to support this claim of substantial equivalence and to show that the technological differences do not raise any new questions pertaining to safety and effectiveness.

Kathleen Rutherford
Kathleen M. Rutherford

Manager, Regulatory Submissions

5/12/99
Date

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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 & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is an abstract image of an eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG - 3 1999

Jamie Yieh Technical Specialist, Regulatory Submissions Siemens Medical Systems, Inc. 186 Wood Avenue South Iselin, New Jersey 08830

RE:

K991652 High End Gradients for Magnetom Symphony Dated: May 12, 1999 Received: May 13, 1999 Regulatory Class: II 21 CFR 892.1000/Procode: 90 LNH

Dear Ms. Yieh:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known)

High End Gradients for the MAGNETOM SYMPHONY Device Name: System

Indications for Use:

(please do not write below this line- continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation
Prescription Use	OR	Over-The-Counter Use
	(Division Sign-Off)and Radiological Deyices510(k) Number	Division of Reproductive, Abdominal, ENT,

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.