The Siemens Interactive MR Localizer is indicated for use as a navigation system. The Interactive THE Localizer performs interactive slice positioning with a pointing instrument for planning and control of interventional and interoperative procedures. The system comprises of a stereoscopic camera, a sterilizable pointing device, a calibration phantom, and an Interactive MR (IMR) software.

Device Description

The Interactive MR Localizer is a navigation system for the MAGNETOM Open and Open viva System.

AI/ML Overview

The provided text is a 510(k) summary for the "Interactive MR Localizer" device, intended for use with MAGNETOM Open and Open viva Systems. It focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific acceptance criteria and performance studies in the way one might find for a novel diagnostic algorithm.

Therefore, many of the requested details about acceptance criteria, specific performance metrics, sample sizes, expert involvement, and ground truth establishment are not explicitly mentioned in this document. The document primarily addresses the safety and effectiveness from the perspective of substantial equivalence to existing MR systems, stating that the modifications described do not raise new questions.

Here's an analysis of what information can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Explicitly Stated in Document)	Reported Device Performance (as per document)
Max Static Field Action Level	Unaffected by modifications
Rate of Change of Magnetic Field Action Level	Unaffected by modifications
RF Power Deposition Action Level	Unaffected by modifications
Acoustic Noise Levels Action Level	Unaffected by modifications
Specification Volume Performance Level	Unaffected by modifications
Signal to Noise Performance Level	Unaffected by modifications
Image Uniformity Performance Level	Unaffected by modifications
Geometric Distortion Performance Level	Unaffected by modifications
Slice Profile, Thickness, and Gap Performance Level	Unaffected by modifications
High Contrast Spatial Resolution Performance Level	Unaffected by modifications
Overall Goal: Substantial Equivalence	Achieved through laboratory testing

Note: The document states these parameters are "unaffected by the modifications described within this notification," implying they meet the established performance levels for the base MAGNETOM Open and Open viva System.

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

Not specified. The document mentions "laboratory testing" but does not provide any details about the size or characteristics of any test set used.
Data Provenance: Not specified.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

Not applicable/Not specified. The nature of "laboratory testing" for substantial equivalence of an MR localizer does not typically involve expert review in the same way an AI diagnostic algorithm would. The testing likely focused on physical and technical performance specifications rather than clinical diagnostic accuracy against a ground truth established by experts.

4. Adjudication Method for the Test Set:

Not applicable/Not specified. Given the type of device and the nature of the stated "laboratory testing," expert adjudication for a test set is not explicitly mentioned or implied.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No. The document does not mention any MRMC study comparing human readers with and without AI assistance. This device is a navigation system, not a diagnostic AI algorithm intended to assist human interpretation of images.

6. Standalone Performance Study (Algorithm only):

Partially applicable, but for hardware/software integration, not a diagnostic algorithm. The "laboratory testing" mentioned supports the claim that the "technological differences do not raise any new questions pertaining to safety and effectiveness" for the integrated system. This implies a form of standalone testing for the Interactive MR Localizer's functionality within the MAGNETOM system, but it's not a standalone diagnostic algorithm performance as might be expected for an AI device. No specific metrics for "algorithm only" performance are provided beyond the statement of "unaffected" performance metrics for the overall MR system.

7. Type of Ground Truth Used:

Not explicitly specified in the context of diagnostic accuracy. For the performance levels mentioned (e.g., Signal to Noise, Geometric Distortion), the ground truth would likely be established through physical measurements using phantoms, calibrated instruments, and established engineering standards, rather than expert consensus, pathology, or outcomes data.

8. Sample Size for the Training Set:

Not applicable/Not specified. This device is described as a "navigation system" and not a machine learning or AI algorithm that requires a training set in the conventional sense.

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

Not applicable/Not specified. As there is no mention of a training set, the establishment of its ground truth is not discussed.

In summary: This 510(k) submission focuses on demonstrating that the "Interactive MR Localizer" is substantially equivalent to existing MR systems and that its integration does not negatively impact the established safety and performance parameters of the core MR device. It does not contain the detailed study results, acceptance criteria for diagnostic accuracy, or AI-specific validation metrics that would be expected for an AI-powered diagnostic device. The "acceptance criteria" presented are essentially that the modified MR system maintains the performance and safety characteristics of the predicate device across various physical and imaging parameters.

Summary

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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
Contact Person: Mr. Jamie Yieh Technical Specialist, Regulatory Submissions (732) 321-4625 (732) 321-4841
03/11/99 Date of Summary Preparation:

Device Name:

Interactive MR Localizer / MAGNETOM Open and • Trade Name: Open viva System
· 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:

The Interactive MR Localizer is a navigation system for the MAGNETOM Open and Open viva System.

• Intended Use

Interactive slice positioning with a pointing instrument and stereoscopic camera system for planing and control of interventional and interoperative procedures.

· Technological Characteristics

The magnet, RF system, and gradient system, of the MAGNETOM Open and Open viva System configured with the Interactive MR Localizer is substantially equivalent to the standard the MAGNETOM Open and Open viva System.

· General Safetv and Effectiveness Concerns:

Operation of the MAGNETOM Open and Open viva System configured with the Interactive MR Localizer is substantially equivalent to standard operation of the MAGNETOM Open and Open viva System. The following safety parameter 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 are unaffected by the modifications described within this notification.

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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

3/11/99
Date

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - I 1993

Jamie Yieh Siemens Medical Systems, Inc. 186 Wood Avenue South Iselin, NJ 08830

Re:

K990826 MR Localizer for Magnetom Open and Open Viva Systems Dated: August 9, 1999 Received: August 10, 1999 Regulatory class: II 21 CFR 892.1000/Procode: 90 LNH

Dear Mr. 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). 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 requlatory 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) _____________________________________________________________________________________________________________________________________________________

Device Name: Interactive MR Localizer

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
Division of Reproductive, Abdominal, ENT,
and Radiological Devices)

510(k) Number	K990826
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Regulation Number and Section

N/A