MAXINSIGHT by EEMAGINE MEDICAL IMAGING SOLUTIONS GMBH

The software is intended for use by a trained/qualified MEG technologist or physician on both adult and pediatric subjects for the visualization of human brain function by fusing a variety of magnetoencephalographic (MEG) and electroencephalographic (EEG) information with rendered images of either an idealized head model and an idealized magnetic resonance (MR) image or a subject's MR image based head model and the subject's MR images

Device Description

The MaxInsight ™ software is a software-only product. It runs on a personal computer and requires no specialized hardware. It displays digitized MEG signals, topographic maps, etc. It displays electrical brain activity correlated to anatomical brain information, which is provided by means of either an idealized head model and an idealized MRI image or a subject's MRI image based head model and the subject's MRI images. These functions are all controlled and interpreted by the user. The MaxInsight software imports digital MEG and co-registered EEG data (in the Neuromag Functional Image File Format) and permits its visualization. The digitized MEG/EEG input is read from a file on the personal computer (or available across the network). The software also provides a report generator to transfer relevant information, such as patient and recording information, event information, topographic images and images of brain activity, to a printable document.

AI/ML Overview

The provided text does not contain detailed information about the acceptance criteria and a specific study proving the device meets these criteria in the format requested. The document is a 510(k) summary for the MaxInsight™ Electroencephalograph Software, focusing primarily on demonstrating substantial equivalence to a predicate device.

Here's a breakdown of what is available and what is missing:

The document states:

"Predetermined software development processes were employed in the design and testing of this software product, and validation testing was performed to ensure compliance with the product specifications."
"The tests demonstrated that the device is as safe, as effective, and performs in a substantially equivalent manner to the predicate device."
"After analyzing both bench and clinical testing data, it is the precedes as not relies and Jang Solutions GmbH that the MaxInsight™ software is as safe and effective as the predicate devices, has few technological differences, and has no new indication for use, thus rendering it substantially equivalent to the data analysis package of the predicate devices."

However, these statements are general affirmations and do not provide the specific details requested in your prompt.

Missing Information:

Specific Acceptance Criteria and Reported Device Performance Table: The document does not provide a table outlining specific performance metrics (e.g., accuracy, sensitivity, specificity, computational speed) that the device was tested against, nor does it report the device's performance results quantitatively.
Sample Size for Test Set and Data Provenance: No information is given about the number of cases or patients used in any "clinical testing data" or "validation testing," nor their origin (country, retrospective/prospective).
Number and Qualifications of Experts for Ground Truth: There is no mention of experts used to establish ground truth for a test set.
Adjudication Method: No adjudication method is described.
Multi-reader Multi-case (MRMC) Comparative Effectiveness Study: There is no indication that an MRMC study was performed, nor any effect size regarding human reader improvement with AI assistance.
Standalone Performance Study: While the device is software-only, "standalone performance" in the context of diagnostic accuracy metrics is not reported. The focus is on its function as a visualization tool; its "performance" is implicitly tied to its ability to display signals and images accurately as intended.
Type of Ground Truth: The document does not specify the type of ground truth used for any testing (e.g., expert consensus, pathology, outcomes data).
Sample Size for Training Set: Since this is not an AI/ML device in the modern sense (it's visualization software), there isn't a "training set" as conceptualized for machine learning algorithms.
How Ground Truth for Training Set was Established: Not applicable given the nature of the device.

In summary, the provided 510(k) summary for K070358 focuses on demonstrating substantial equivalence of a medical imaging visualization software to a predicate device through general statements about software development processes and "bench and clinical testing data." It does not provide the detailed performance metrics, study designs, or ground truth methodologies typically found in submissions for devices that make diagnostic claims based on algorithmic analysis or where quantitative performance against a specific standard is required to prove effectiveness.

Summary

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K070358

JUL 3 0 2007

510(K) Summary Page 1 of 2 eemagine Medical Imaging Solutions GmbH Gubener Str. 47 D-10243 Berlin Germany Phone +49 (0)30 29048404 +49 (0)30 29048405 Fax e-mail info@eemagine.com Contact: Frank Zanow, President Date prepared: June 23, 2007

Trade Name: MaxInsight™ 1. Common Name: Electroencephalograph Software Classification Name: Electroencephalograph, product code OLK Regulation: 882.1400 Class of device: Class II.
The legally marketed device to which we are claiming equivalence [807.92(a)(3)] : 2. K041264, Elekta Neuromag, manufactured by Elekta Neuromag Oy
Description of device: The MaxInsight ™ software is a software-only product. It runs 3. on a personal computer and requires no specialized hardware. It displays digitized MEG signals, topographic maps, etc. It displays electrical brain activity correlated to anatomical brain information, which is provided by means of either an idealized head model and an idealized MRI image or a subject's MRI image based head model and the subject's MRI images. These functions are all controlled and interpreted by the user. The MaxInsight software imports digital MEG and co-registered EEG data (in the Neuromag Functional Image File Format) and permits its visualization. The digitized MEG/EEG input is read from a file on the personal computer (or available across the network). The software also provides a report generator to transfer relevant information, such as patient and recording information, event information, topographic images and images of brain activity, to a printable document.
Intended use: The software is intended for use by a trained/qualified MEG 4. technologist or physician on both adult and pediatric subjects for the visualization of human brain function by fusing a variety of magnetoencephalographic (MEG) and electroencephalographic (EEG) information with rendered images of either an idealized head model and an idealized magnetic resonance (MR) image or a subject's MR image based head model and the subject's MR images
Technological characteristics: Both MaxInsight™ and the data analysis software of ર. Elekta Neuromag support the following digital MEG/EEG review, topographic magnetic fields, topographic voltage. Both require that the signal be digitized by a separate MEG/EEG acquisition system. MaxInsight is a software only product, whereas the analysis software package of Elekta Neuromag is part of a system to measure and analyze MEG and optionally EEG signals ..

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510(K) Summary Page 2 of 2 eemagine Medical Imaging Solutions GmbH

Predetermined software development processes were employed in the હ. Performance: design and testing of this software product, and validation testing was performed to ensure compliance with the product specifications. The tests demonstrated that the device is as safe, as effective, and performs in a substantially equivalent manner to the predicate device. After analyzing both bench and clinical testing data, it is the precedes as not relies and Jang Solutions GmbH that the MaxInsight™ software is as safe and effective as the predicate devices, has few technological differences, and has no new indication for use, thus rendering it substantially equivalent to the data analysis package of the predicate devices.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol. The logo is in black and white.

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

Eemagine Medical Imaging Solutions GMBH c/o Mr. Daniel Kamm Kamm & Associates P.O. Box 7007 Deerfield, IL 60015

APR - 9 2012

Re: K070358 Trade/Device Name: Maxinsight™ Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: II Product Code: OLX Dated (Date on orig SE ltr): June 23, 2007 Received (Date on orig SE ltr): June 25, 2007

Dear Mr. Kamm:

This letter corrects our substantially equivalent letter of July 30, 2007.

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 (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.

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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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Malvina B. Eydelman, M.D. Director Division of Ophthalmic. Neurological. and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name:__________________________________________________________________________________________________________________________________________________________________

Indications For Use:

The software is intended for use by a trained/qualified MEG technologist or physician on both adult and pediatric subjects for the visualization of human brain function by fusing a variety of magnetocncephalographic (MEG) and electroencephalographic (EEG) information with rendered images of either an idealized head model and an idealized magnetic resonance (MR) image or a subject's MR image based head model and the subject's MR images

Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Erallustion (ODE)

(Division S

Division of Gene storative. and Normingical

Number Page 6 of 65

Regulation Number and Section

§ 882.1400 Electroencephalograph.

(a)
Identification. An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.(b)
Classification. Class II (performance standards).