The MAGNETOM Trio system is a whole body scanner designed to support higher resolution imaging and shorter scan times. The Trio system is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images of the internal structures of the head and whole body. The images produced by the Trio system 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 echo time (T2) and flow. When interpreted by a trained physician, these images provide information that can be useful in determining diagnosis.

Device Description

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information for the Siemens MAGNETOM Trio System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document lists "safety parameters with action levels" and "performance levels" that were evaluated. It states that the "new levels are not significantly changed and, in the case of safety, parameters remain below the level of concern." However, specific numerical acceptance criteria (e.g., minimum SNR value, maximum geometric distortion percentage) and the exact reported device performance values are not provided in the given text.

Acceptance Criteria Category	Specific Parameter	Acceptance Criteria (Not explicitly stated with numerical values)	Reported Device Performance (Not explicitly stated with numerical values)
Safety Parameters	Maximum Static Field	Below the level of concern (implied)	Not significantly changed from predicate, below level of concern
	Rate of Change of Magnetic Field	Below the level of concern (implied)	Not significantly changed from predicate, below level of concern
	RF Power Deposition	Below the level of concern (implied)	Not significantly changed from predicate, below level of concern
	Acoustic Noise Levels	Below the level of concern (implied)	Not significantly changed from predicate, below level of concern
Performance Levels	Specification Volume	Derived from FDA guidance (implied)	Not significantly changed from predicate
	Signal to Noise	Derived from FDA guidance (implied)	Not significantly changed from predicate
	Image Uniformity	Derived from FDA guidance (implied)	Not significantly changed from predicate
	Geometric Distortion	Derived from FDA guidance (implied)	Not significantly changed from predicate
	Slice Profile, Thickness and Gap	Derived from FDA guidance (implied)	Not significantly changed from predicate
	High Contrast Spatial Resolution	Derived from FDA guidance (implied)	Not significantly changed from predicate

2. Sample Size Used for the Test Set and Data Provenance

The document states "Laboratory testing were performed to support this claim of substantial equivalence," but it does not specify the sample size used for the test set.

Sample Size (Test Set): Not specified.
Data Provenance: The study was conducted as "Laboratory testing." The country of origin of the data is not specified, but the applicant is based in the US (Siemens Medical Systems, Inc., Iselin, N.J.). The study type is prospective laboratory testing, as it was performed to support the 510(k) submission.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not provided in the document. The testing described appears to be technical performance testing against established FDA guidance parameters for MR diagnostic devices, rather than a clinical study requiring expert interpretation for ground truth.

4. Adjudication Method for the Test Set

This information is not applicable/provided. The study described focuses on technical performance parameters of an MRI system, not on diagnostic accuracy based on expert adjudication of images.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not described in the provided text. The submission focuses on demonstrating substantial equivalence through technical performance evaluation against established guidance documents, not comparing human reader performance with and without AI assistance. The device is an MRI system, not an AI-powered diagnostic device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, in spirit, a standalone technical performance evaluation was done. The document states that "Laboratory testing were performed" to evaluate parameters like Signal to Noise, Image Uniformity, Geometric Distortion, etc. This testing assesses the inherent performance characteristics of the device itself, without necessarily involving human interpretation for diagnostic purposes, in the context of demonstrating substantial equivalence to predicate devices. The device described is a whole-body MRI scanner, and the "standalone" performance relates to its physical and technical capabilities as an imaging device.

7. The Type of Ground Truth Used

The "ground truth" for the technical performance parameters was established by FDA guidance documents for MR Diagnostic Devices. The document states that the safety and performance parameters "specified by the FDA guidance document for MR Diagnostic Devices were evaluated within this notification." This implies a comparison to acceptable ranges or thresholds defined by regulatory standards.

8. The Sample Size for the Training Set

This information is not applicable/provided. The device is an MRI system (hardware), not an AI algorithm that requires a training set of data.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable/provided for the same reason as point 8.

Summary

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1101 3586

11 Appendix: 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:
	• Address:	Siemens Medical Systems, Inc.186 Wood Avenue SouthIselin, N.J. 08830
	Registration Number:	2240869
	Contact Person:	Mr. Jamie YiehTechnical Specialist, Regulatory AffairsPhone: (732) 321-4625Fax: (732) 321-4841Email: jamie.yieh@siemens.com
	Date of Summary Preparation:	10/29/01
	Device Name:
	•Trade Name:	MAGNETOM Trio System
	•Classification Name:	Magnetic Resonance Diagnostic Device, CFR §
	•Classification:	Class II
	•Performance Standards:	None established under Section 514 the Food, Drug, and Act.

892.1000

Cosmetic

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II. Safety and Effectiveness Information Supporting Substantial Equivalence.

· Device Description:

• Intended Use

· Technological Characteristics

The MAGNETOM Trio System is substantially equivalent to both the MAGNETOM 3.0 T Allegra Dedicated Head only System and GE's Body Imaging Coil for 3.0T Signa VH/I system.

· General Safety and Effectiveness Concerns:

Operation of the MAGNETOM Trio System is substantially equivalent to the commercially available MAGNETOM 1.5 T Sonata System and 3.0 T Dedicated Head Only Allegra System. The following are the safety parameter 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 increase in static magnetic field of the system will affect the maximum static field and acoustic noise level, 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.

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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.

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Image /page/3/Picture/1 description: The image is a black and white seal for the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three overlapping human profiles facing to the right. The profiles are arranged in a way that suggests unity and collaboration.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 8 2001

Mr. Jamie Yieh Technical Specialist, Regulatory Affairs Siemens Medical Systems, Inc. 186 Wood Avenue South ISELIN NJ 08830

Re: K013586

Trade/Device Name: Magnetom Trio System Magnetic resonance imaging system Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: 90 LNH Dated: October 29, 2001 Received: October 30, 2001

Dear Mr. Yieh:

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); good manufacturing practice requirements as set forth in the quality systems (OS) 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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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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

8xx.1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known) 人のノ 35 86

MAGNETOM Trio System Device Name:

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

cun broadon

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices Ko13586
510(k) Number.

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.