The MAGNETOM C! is indicated for use as magnetic resonance diagnostic devices (MRDD) that produce transverse, sagittal, coronal and oblique cross sectional images, and that display the internal structure and/or function of the head, body, or extremities. Depending on the region of interest, contrast agents may be used. These images when interpreted by a trained physician yield information that may assist in diagnosis.

The MAGNETOM C! 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.

Disclaimer: Utility of contrast enhanced breast MRI for the detection of breast masses has not been documented and is thus not indicated.

Device Description

The MAGNETOM C! system is an open, whole body scanner designed to support improved higher resolution imaging and shorter scan times, which was described in premarket notification K043030 which received FDA clearance on December, 10, 2004. Siemens intends to modify the RF Infra Structure, RF Signal Unit, Filter Plate, Gradient Amplifier, Physiological Measurement Unit, Measurement and Reconstruction System, Magnet Temperature Unit, Patient Table Control, Power Distribution System, External Field Interference, Integrated Cooling System and software update for the existing MAGNETOM C! Magnetic Resonance System.

AI/ML Overview

The provided text is a 510(k) summary for a Magnetic Resonance Diagnostic Device (MRDD) named MAGNETOM C!. This document is a submission for a modification to an already cleared device, and as such, it focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against new, specific acceptance criteria through a clinical study.

Therefore, the text does not contain a detailed clinical study with acceptance criteria and reported device performance metrics in the way one might expect for a new, de novo device or a device claiming superiority. Instead, it relies on demonstrating that the modifications do not alter the fundamental safety and effectiveness, and that the device continues to conform to established standards for MRDDs.

Here's how to address the questions based on the provided text, highlighting where information is not available due to the nature of this 510(k) submission:

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

The document does not provide a table of acceptance criteria and reported device performance in the traditional sense of a clinical study. Instead, it lists performance levels that will be evaluated based on the modifications to ensure substantial equivalence:

Performance Level	Acceptance/Evaluation Method	Reported Performance
Signal to Noise	Conformance to FDA recognized NEMA Standards for MRDDs	Not quantitatively reported in this document. Assumed to meet NEMA standards.
Image Uniformity	Conformance to FDA recognized NEMA Standards for MRDDs	Not quantitatively reported in this document. Assumed to meet NEMA standards.
Geometric Distortion	Conformance to FDA recognized NEMA Standards for MRDDs	Not quantitatively reported in this document. Assumed to meet NEMA standards.
High Contrast Spatial Resolution	Conformance to FDA recognized NEMA Standards for MRDDs	Not quantitatively reported in this document. Assumed to meet NEMA standards.
Slice Thickness	Conformance to FDA recognized NEMA Standards for MRDDs	Not quantitatively reported in this document. Assumed to meet NEMA standards.

The document states that the MAGNETOM C! "will conform to the FDA recognized NEMA Standards for the measurement of performance and safety parameters and the international IEC standard for safety issues with Magnetic Resonance Imaging Devices." This implies that conformance to these standards serves as the acceptance criteria for the evaluated performance levels. However, it does not provide specific numerical performance results from a study within this text.

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

This information is not available in the provided text. The submission focuses on hardware and software modifications and their conformance to established standards for MR devices, rather than a clinical trial with a "test set" of patient data for diagnostic performance evaluation.

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)

This information is not available in the provided text. As there is no clinical study described with a "test set" requiring ground truth establishment, this detail is not relevant to this submission. The "trained physician" mentioned in the Indications for Use is a general statement about the interpretation of MR images, not specific to a study design.

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

This information is not available in the provided text as no clinical study with a test set is detailed.

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

There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study, nor any evaluation of AI assistance. This device is an MRI system, not an AI-powered diagnostic tool as described in this submission.

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

This information is not applicable/not available. The MAGNETOM C! is a Magnetic Resonance Diagnostic Device (an MRI machine), not a standalone algorithm. Its performance is inherent in its ability to produce images for human interpretation.

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

This information is not available in the provided text as no clinical study requiring ground truth is detailed.

8. The sample size for the training set

This information is not available in the provided text. This submission does not describe a machine learning algorithm requiring a "training set."

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

This information is not available in the provided text. This submission does not describe a machine learning algorithm requiring a "training set" or ground truth for it.

Summary of the Study Proving Device Meets Acceptance Criteria (as per the provided text):

The "study" described in the 510(k) summary is not a traditional clinical trial with patient subjects and diagnostic outcomes. Instead, it is a demonstration of substantial equivalence for a modified medical device.

Acceptance Criteria: The primary acceptance criterion for this submission is that the modified MAGNETOM C! system maintains its safety and effectiveness and continues to conform to existing recognized standards for Magnetic Resonance Diagnostic Devices (MRDDs) after the specified hardware and software modifications. Specifically, it must conform to:
- FDA recognized NEMA Standards for the measurement of performance parameters (Signal to Noise, Image Uniformity, Geometric Distortion, High Contrast Spatial Resolution, Slice Thickness).
- International IEC standard for safety issues with Magnetic Resonance Imaging Devices.
Study Proving Acceptance: The manufacturer, Siemens Medical Solutions, Inc., asserts that the operation of the modified MAGNETOM C! System is substantially equivalent to the previously cleared MAGNETOM C! (K043030) and 1.5 T ESSENZA System (K071925). The "study" involves evaluating the specified performance levels (Signal to Noise, Image Uniformity, Geometric Distortion, High Contrast Spatial Resolution, and Slice Thickness) to ensure they meet the established NEMA standards. The document, however, does not provide the specific results or methodology of this evaluation within the text. It states that "the MAGNETOM C! will conform" to these standards, implying that internal testing or engineering assessments were conducted to verify this conformance.

In essence, this 510(k) submission relies on a comparison to predicate devices and adherence to established technical standards for MR systems, rather than a de novo clinical performance study against specific diagnostic acceptance criteria.

Summary

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510(k) Summary 5

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. Inc.51 Valley Stream ParkwayMalvern. PA 19355
---------------	----------------------------------------------------------------------------------

Registration Number 2240869

Manufacturer Siemens Mindit Magnetic Resonance Ltd. Siemens MRI Center, Gaoxin C. Ave. 2nd Hi-Tech Industrial Park, ShenZhen 518057, PR. China
Registration Number 3004754211

Contact Person Ms. Judy Campbell Technical Specialist. Regulatory Submissions 51 Valley Stream Parkway Malvern. PA 19355 Phone: (610)448-4918 Fax: (610) 448-1787

Device Name
Trade Name:	MAGNETOM C! System
Classification Name:	Magnetic Resonance Diagnostic Device
CFR Code:	21 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.

Intended Use

The MAGNETOM C! 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.

Disclaimer: Utility of contrast enhanced breast MRI for the detection of breast masses has not been documented and is thus not indicated.

Device Description

Substantial Equivalence

Siemens believes that, within the meaning of the Safe Medical Device Act of 1990, the MAGNETOM C!, which is configured with modified hardware and software, is substantially equivalent to the following cleared medical devices, which offers the same applications and handling:

Predicate Device Name	FDA ClearanceNumber	FDA ClearanceDate
Siemens MAGNETOM 1.5TESSENZA	K071925	08/14/2007
Siemens MAGETOM 0.35 T C !	K043030	12/10/2004

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General Safety and Effectiveness Concerns

Operation of the MAGNETOM C! System is substantially equivalent to the commercially available MAGNETOM C! (K043030) System and 1.5 T ESSENZA System (071925). Below are the parameters specified by the FDA guidance document for MR Diagnostic Devices that will be evaluated based on the modifications:

Performance Levels

· Signal to Noise
· Image Uniformity
· Geometric Distortion
· High Contrast Spatial Resolution
· Slice Thickness

Safety Levels

None

The MAGNETOM C! will conform to the FDA recognized NEMA Standards for the measurement of performance and safety parameters and the international IEC standard for safety issues with Magnetic Resonance Imaging Devices This will assure that the performance of this device can be considered safe and effective with respect to the currently available MAGNETOM C!( K043030) and MAGNETOM ESSENZA (K071925).

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Image /page/3/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and care. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", indicating the department's name and national affiliation.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 01 2008

Ms. Judith Campbell Regulatory Technical Specialist Siemens Medical Solutions USA, Inc. 51 Valley Stream Parkway MALVERN PA 19355

Re: K082331

Trade/Device Name: MAGNETOM C! Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Codc: LNH and MOS Dated: August 11, 2008 Received: August 14, 2008

Dear Ms. Campbell:

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. Iisting 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 such 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.

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Page 2

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 (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.

This letter will allow you to begin marketing your device as described in your Section 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:

21 CFR 876.xxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 894.xxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

hoque An Whang

Joyce M. Whang, Ph.D. Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement 4

510(k) Number (if known)

Device Name: MAGNETOM C!

Indications for Use:

The MAGNETOM C! is indicated for use as maqnetic resonance diagnostic devices (MRDD) that produce transverse, sagittal, coronal and oblique cross sectional images, and that display the internal structure and/or function of the head, body, or extremities. Depending on the region of interest, contrast agents may be used. These images when interpreted by a trained physician yield information that may assist in diagnosis.

The MAGNETOM C! 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

Disclaimer: Utility of contrast enhanced breast MRI for the detection of breast masses has not been documented and is thus not indicated.

(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 Use

tion Use
OR

(Division Division of Reproductive, Abdominal and Radiological Devices 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.