The MAGNETOM Prisms and MAGNETOM Prismalit systems are indicated for use as a magnetic resomance diagnostic device (MRDD) that produces transverse, sagital, coronal and oblique cross sectional 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 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 Prisma and MAGNETOM Prismalit systems may also be imaging during interventional procedures when performed with MR compatible devices such as in-room display and MR Safe biopsy needles.

Device Description

MAGNETOM Prisma (3 T) and MAGNETOM Prisma" (3 T) are similar to the previously cleared MAGNETOM Skyra (3 T) and MAGNETOM Trio a Tim System (TaTS) (3 T) systems utilizing a superconducting magnet design. The open bore, whole body scanners are designed for increased patient comfort. They focus on ergonomics and usability to reduce complexity of the MR workflow.

The MAGNETOM Prisma will be offered as ex-factory (new production) and the MAGNETOM Prismall will be offered as an upgrade to the currently installed MAGNETOM Trio a Tim System (TaTS) systems.

AI/ML Overview

The provided text is a 510(k) summary for the Siemens MAGNETOM Prisma and MAGNETOM Prisma™ MR systems. It asserts substantial equivalence to predicate devices and describes safety and performance testing. However, it does not contain specific acceptance criteria values, reported device performance metrics against those criteria, or the detailed study design (like sample sizes for test sets, data provenance, expert qualifications, or ground truth establishment) typically associated with such criteria for a medical device's performance.

The document states that the new devices conform to "measurements of safety parameters to the international IEC, ISO and NEMA standards for safety issues with Magnetic Resonance Imaging Diagnostic Devices" and that "performance testing has been completed to show that the performance... is equivalent with respect to the predicate devices." It lists areas of safety and performance evaluated but does not provide quantitative results or explicit acceptance thresholds.

Summary of Missing Information:

The input document does not contain the level of detail required to complete the requested table and study information. Specifically, it lacks:

Quantitative acceptance criteria values.
Reported device performance metrics.
Sample sizes for test sets.
Data provenance for test sets.
Number and qualifications of experts for ground truth.
Adjudication method for test sets.
Information on MRMC comparative effectiveness studies (effect size of AI improvement).
Information on standalone algorithm performance.
Type of ground truth used (beyond implying "equivalence" to predicate devices).
Sample size and ground truth establishment for the training set.

Based on the provided text, here is what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Metric (as mentioned or implied)	Acceptance Criteria	Reported Device Performance
Safety	Maximum Static Field	Conforms to IEC, ISO, NEMA standards	Shown to conform to standards and be equivalent to predicate devices
	Rate of Change of Magnetic Field	Conforms to IEC, ISO, NEMA standards	Shown to conform to standards and be equivalent to predicate devices
	RF Power Deposition	Conforms to IEC, ISO, NEMA standards	Shown to conform to standards and be equivalent to predicate devices
	Acoustic Noise Levels	Conforms to IEC, ISO, NEMA standards	Shown to conform to standards and be equivalent to predicate devices
Performance	Specification Volume	Equivalent to predicate devices	Shown to be equivalent to predicate devices
	Signal to Noise	Equivalent to predicate devices	Shown to be equivalent to predicate devices
	Image Uniformity	Equivalent to predicate devices	Shown to be equivalent to predicate devices
	Geometric Distortion	Equivalent to predicate devices	Shown to be equivalent to predicate devices
	Slice Profile, Thickness and Gap	Equivalent to predicate devices	Shown to be equivalent to predicate devices
	High Contrast Spatial Resolution	Equivalent to predicate devices	Shown to be equivalent to predicate devices

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 states that "performance testing has been completed," but it does not specify the sample size, data provenance, or whether the study was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

The document does not provide any information regarding the number or qualifications of experts used to establish ground truth for test sets.

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

The document does not specify any adjudication method for test sets.

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 describes the device as a Magnetic Resonance Diagnostic Device (MRDD), implying it's an imaging system, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC comparative effectiveness study regarding "human readers improve with AI vs without AI assistance" is not applicable or mentioned in this context. The focus is on the equivalence of the MR system's performance itself.

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

This refers to the performance of the MR system itself. The document confirms that performance testing was completed to show equivalence to predicate devices, which implies standalone performance evaluation of the imaging system. However, specific metrics and methodologies for a "standalone algorithm" performance in the sense of AI are not described, as this device is a hardware imaging system.

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

The document states that performance testing was done "following NEMA or equivalent IEC and ISO standards." This suggests that physical phantoms and standardized measurement techniques, which serve as the "ground truth" for technical imaging specifications, were likely used. However, it does not explicitly state "expert consensus, pathology, or outcomes data" as ground truth for clinical cases. The ground truth for proving substantial equivalence appears to be established by demonstrating that the new system's technical specifications and image quality measurements are comparable to the predicate devices and conform to industry standards.

8. The sample size for the training set

This document describes a medical imaging device (hardware and core software), not an AI algorithm that undergoes "training." Therefore, the concept of a "training set sample size" is not applicable in this context.

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

As per point 8, the concept of a "training set" for AI is not applicable to this device description.

Summary

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K132119

NOV 22222013 SIEMENS

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.

l. General Information

Establishment	Siemens Medical Solutions USA. Inc.51 Valley Stream ParkwayMail Code D02Malvern, PA 19355, USA
Registration Number	2240869
Date Prepared	July 8, 2013
Manufacturer	Siemens AGHenkestrasse 127D-91052 Erlangen, Germany
Registration Number	3002808157
Contact Person	Ms. Nadia SookdeoRegulatory Affairs Technical SpecialistSiemens HealthcareSiemens Medical Solutions USA, Inc.Customer Solutions Group51 Valley Stream ParkwayMail Code G01Malvern, PA 19355, USAPhone: (610) 448-4918Fax: (610) 448-1787
Device Name	Trade Names: MAGNETOM PrismaMAGNETOM Prismafi
Classification Name:CFR Code:Classification:	Magnetic Resonance Diagnostic Device21 CFR § 892.1000Class II
Performance Standards	None established under Section 514 Subpart

the Food, Drug and Cosmetic Act.

J of

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SIEMENS

Image /page/1/Picture/1 description: The image shows a black and white abstract design. The design features a scattering of small, irregular black shapes against a white background. The shapes are concentrated towards the bottom left corner of the image, with a few isolated shapes dispersed towards the top.

II. Safety and Effectiveness Information Supporting Substantial Equivalence

Intended Use

The MAGNETOM Prisma and the MAGNETOM Prisma™ systems 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 vield information that may assist in diagnosis.

The MAGNETOM Prisma and the MAGNETOM Prisma" MR 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 MAGNETOM Prisma will be offered as ex-factory (new production) and the MAGNETOM Prismall will be offered as an upgrade to the currently installed MAGNETOM Trio a Tim System (TaTS) systems.

Substantial Equivalence

It is Siemens opinion that the MAGNETOM Prisma systems and the upgraded MAGNETOM Prismad systems with syngo® MR VD13D software i are substantially equivalent to the following predicate devices:

Predicate Device Name	FDA Clearance Number	FDA Clearance Date
Siemens MAGNETOM Skyra (3 T) MRsystem with syngo® MR D13D	K123510	May 17, 2013
Siemens MAGNETOM Trio a Tim System(TaTS) (3 T) MR System with syngo® MRB19	K123938	February 12, 2013

Safety and Effectiveness

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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 beginning early in the design cycle and continuing throughout the development of the product.. These potential hazards are controlled by software means, user instructions, verification of requirements and validation of the clinical workflow to ensure that the product meets its intended uses. To minimize electrical, mechanical and radiation hazards. SIEMENS adheres to recognized and established industry practice and relevant international standards, such as the IEC 60601-1 series.

Operation of the MAGNETOM Prisma (3T) and the MAGNETOM Prisma" (3T) systems with syngo® MR VD13D software is substantially equivalent to the commercially available MAGNETOM Skyra (3T) Systems with syngo® MR VD13C SW (K123510) and MAGNETOM Trio a Tim System (TaTS) (3T) with syngo® MR B19 SW (K123938)

Additionally, as specified in the FDA quidance document "Guidance for the Submission Of Premarket Notifications for Magnetic Resonance Devices" (released Nov. 1998) the following measurements of performance and safety data have been performed following NEMA or equivalent IEC and ISO standards:

Safety:

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

Performance:

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

The MAGNETOM Prisma and MAGNETOM Prisma™ syngo® MR VD13D software will conform to the measurements of safety parameters to the international IEC, ISO and NEMA standards for safety issues with Magnetic Resonance Imaging Diagnostic Devices.

Furthermore performance testing has been completed to show that the performance of the MAGNETOM Prisma and MAGNETOM Prisma™ with syngo® MR VD 13D Software is equivalent with respect to the predicate devices.

This assures that the performance of these devices can be considered as safe and effective with respect to the currently available MAGNETOM Skyra and MAGNETOM Trio a Tim System (TaTS) MR systems.

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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 consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized symbol that resembles an eagle or bird with outstretched wings.

Public Health Service

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

November 22, 2013

Siemens Medical Solutions USA, Inc. % Ms. Nadia Sookdeo Regulatory Affairs Technical Specialist 51 Valley Stream Parkway, D02 MALVERN PA 19355

Re: K132119

Trade/Device Name: MAGNETOM Prisma, MAGNETOM Prisma 11 Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: November 5, 2013 Received: November 8, 2013

Dear Ms. Sookdeo:

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. Ilsting 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-Ms. Sookdeo

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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" (2)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 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/Industrv/default.htm.

Sincerely yours.

Michael D. O'Hara

for

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

510(k) Number (if known) K132119

Device Name

. –

MAGNETOM Prisma and MAGNETOM Prisma fit

Indications for Use (Describe)

The MAGNETOM Prisma and MAGNETOM Prismalit systems may also be 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)

[X] Prescription Use (Part 21 CFR 801 Subpant D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)	Michael D. O'Hara
------------------------------------------------------------------------------	-------------------

FORM FDA 3881 (9/13)

PSC Publicition Services ( VII ) 441-4740 EF

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.