The SIEMENS MAGNETOM Project 024 is a 1Tesla whole body magnetic resonance imaging (MRI) system intended for general diagnostic use. This MRI system will present images which reflect the spatial distribution and/or magnetic resonance spectra which are a function of the 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.

Device Description

The SIEMENS MAGNETOM Project 024 is a 1.0T vhole body magnetic The SIEMILING MITONETON tern. The MAGNETOM Project 024 is the first resonalice innaging (MRL) byotic resonance imaging (MRI) systems. The meatber of a family of mag-e Project 024 is being introduced as a new system and as an upgrade to the commercially available MAGNETOM Impact system.

AI/ML Overview

The provided document, K970852, is a 510(k) premarket notification for the SIEMENS MAGNETOM Project 024, a 1.0T whole-body magnetic resonance imaging (MRI) system, submitted in 1997. The document aims to demonstrate substantial equivalence to previously cleared devices (MAGNETOM Vision and MAGNETOM Impact systems) rather than explicitly detailing acceptance criteria and performance data from a specific study for this new device.

Therefore, based on the provided text, the document primarily focuses on establishing "substantial equivalence" and does not contain detailed information regarding:

Specific acceptance criteria (numerical thresholds for sensitivity, specificity, accuracy, etc.)
A standalone study proving the device meets those specific criteria.
Sample sizes for test sets, data provenance, ground truth establishment methods for a specific study on this device.
Expert involvement for ground truth, adjudication methods, or MRMC comparative effectiveness studies.
Standalone algorithm performance or training set details.

The document states that the "safety and performance characteristics for this system are within the scope of parameters cleared for market for the MAGNETOM Vision and MAGNETOM Impact systems. No additional safety concerns have been raised." This implies that the new device is expected to perform similarly to its predicates, and a direct comparative effectiveness study with human readers or standalone performance metrics are not presented for the MAGNETOM Project 024 itself.

Consequently, I cannot generate the requested table and detailed study information as it is not present in the provided 510(k) submission.

What can be inferred from the document regarding the "study" or justification for acceptance:

Acceptance Criteria/Performance: Not explicitly defined with quantitative metrics for the MAGNETOM Project 024. The implicit acceptance criterion is "substantial equivalence" to previously cleared MRI systems (MAGNETOM Vision and MAGNETOM Impact). This means its performance is assumed to be comparable to those devices, which would have had their own validation data at the time of their clearance.
Study: There isn't a specific study detailed in this document that proves the MAGNETOM Project 024 meets explicit acceptance criteria. Instead, the submission relies on the assertion that its "safety and performance characteristics...are within the scope of parameters cleared for market for the MAGNETOM Vision and MAGNETOM Impact systems."
Ground Truth: The general diagnostic use of an MRI system inherently relies on medical consensus and clinical outcomes as the ultimate ground truth for its images and derived parameters. However, how this was specifically evaluated for the MAGNETOM Project 024 (or its predicates in this specific submission) is not detailed.

In summary, the provided 510(k) is a declaration of substantial equivalence, not a detailed report of a new clinical study with specific acceptance criteria and performance data for the MAGNETOM Project 024.

Summary

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K970852

SIEMENS

JUN - 5 1997

This summary of 510(k) safety and effectiveness information is being submitted in
t and and and 1 CLC 4 CLCL CLCL 1808 and 21 CER 807 92 This summary of 510(K) Safety and east of SMDA 1990 and 21 CFR 807.92.
accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

	I. General Information.
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Establishment:• Address:	Siemens Medical Systems, Inc.186 Wood Avenue SouthIselin, N.J. 08830
Registration Number:	2240869
Contact Person:	Ms. Kathleen RutherfordManager, Regulatory Submissions(908) 321-4779(908) 321-4841
Date of Summary Preparation:	3/06/97
Device Name:• Trade Name:	MAGNETOM Project 024
• Classification Name:	Magnetic Resonance Diagnostic DeviceCFR § 892.1000
• Classification:	Class II
• Performance Standards:	None established under Section 514 ofthe Food, Drug, and Cosmetic Act.

II. Safety and Effectiveness Information Supporting Substantial Equivalence. Device Description:

The SIEMENS MAGNETOM Project 024 is a 1.0T vhole body magnetic The SIEMILING MITONETON tern. The MAGNETOM Project 024 is the first resonalice innaging (MRL) byotic resonance imaging (MRI) systems. The meatber of a family of mag-e
Project 024 is being introduced as a new system and as an upgrade to the commercially available MAGNETOM Impact system.

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SIEMENS

Intended Use: Whole body magnetic resonance imaging.

Technological Characteristics:

The MAGNETOM Project 024 system is a high field strength system. The new MAGNETOM system has a new compact design and a redesigned patient table and rf coil system.

General Safety and Effectiveness Concerns:

The safety and performance characteristics for this system are within the scope of parameters cleared for market for the MAGNETOM Vision and MAGNETOM Impact systems. No additional safety concerns have been raised.

The device labeling for the Project 024 system will contain instructions for use, indications for use, precautions, cautions, contraindications, and warnings to the user.

Substantial Equivalence:

The MAGNETOM Project 024 system is substantially equivalent to the SIEMENS MAGNETOM Vision and MAGNETOM Impact magnetic resonance imaging systems.

Khtleen Rutherford / CAP

Kathleen M. Rutherford Manager, Regulatory Submissions Imaging Systems Group Siemens Medical Systems, Inc.

3/6/97
Date

Date

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle with three lines representing its wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard --Rockville MD 20850

JUN - 5 1997

Kathleen Rutherford Manager, Regulatory Submissions Siemens Medical Systems, Inc. 186 Wood Avenue South Iselin, NJ 08830

Re: K970852

MAGNETOM Project 024 (Numeris 3.5 Software) Dated: March 6, 1997 Received: March 7, 1997 .. Regulatory class: II 21 CFR 892.1000/Procode: 90 LNH

Dear Ms. Rutherford: 11

We have reviewed your Section 510(k) notification of intent to market the device and we have determined the device is substantially equivalent (for the indications for use stated in interstate commerce pror to May 28, 1976, the enactment date of the Medical 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 general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions egainst misbranding and adulteration.

If your device is classified (see above) into either class II (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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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 does not affect any obligation you might have under sections 51 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(t) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predication 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 (2) CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4591 for Radiology devices, or 594-4613 for Ear, Nose and Throat devices. 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/cdrl/dsmamain.html".

Sincerely yours.

William

Lillian Yin, Ph.D. 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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SIEMENS

510(k) Number (if known)

Device Name: MAGNETOM Project 024

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_

Over-The-Counter

510(k) Number

Shmil C. Seymore
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological I

Siemens Medical Systems, Inc.

Page 1 of 1 -

Imaging Systems Group

186 Wood Avenue South Iselin, NJ 08830

Tel: (908) 321-4500 (908) 494-2250

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.