The Neuromag-122 system is intended for use as a magneto encephalographic (MEG) device which non-invasively detects and displays biomagnetic signals produced by electrically active nerve tissue in the brain. When interpreted by a trained clinician, the data enhances the diagnostic capability by providing useful information about the location relative to brain anatomy of active nerve tissue responsible for critical brain functions.

Device Description

This device integrates 122 SQUID planar gradiometers with medical super-computers and data intracelly long in order to measure the differences in the magnetic signals generated by the intracellular dendritic currents. These detectors are positioned in a helmet shaped array which gives the user the ability to record the electrical activity of the entire surface of the brain simultaneously without having to move the position of the probe.

AI/ML Overview

The provided document is a 510(k) summary for the Neuromag-122 device, establishing its substantial equivalence to a predicate device (Biomagnetic Technologies Magnes Single, K901215A), rather than demonstrating direct evidence of meeting specific acceptance criteria through a clinical study. Therefore, a direct response to some of the questions, such as detailed acceptance criteria and a study proving they are met, cannot be fully provided from the given text.

However, based on the information provided, here's what can be extracted and inferred:

1. Table of acceptance criteria and the reported device performance

The document does not define explicit "acceptance criteria" in the format of specific thresholds for performance metrics. Instead, it argues for "substantial equivalence" based on comparative parameters between the Neuromag-122 and the predicate device. The implicit acceptance criterion is that the Neuromag-122 performs at least as well as, or is sufficiently similar in its technical characteristics and intended use to, the predicate device to be considered safe and effective.

Parameter	Neuromag-122 Performance	Predicate Device (Magnes Single) Performance
No. of SQUID detectors / channels for MEG data	122	37
No. of auxiliary channels for other types of data (e.g EEG)	166 (typically use 32 for EEG)	51
Gradiometer	Two orthogonal planar-first-order gradiometers per location	First order axial gradiometer
Intersensor spacing	43-44 mm	20 mm
Gradiometer placement	Sixty-one locations distributed across helmet-shaped lower tip of dewar. Radius of curvature of helmet is 83 mm (front-portion) and 91 mm (back-portion).	Positioned in a circular array (diameter 14.4 cm) over a concave spherical surface with a 12.2 cm radius of curvature.
Cryogen Used	Liquid Helium	Liquid Helium
Coverage	One acquisition to cover entire head	Six to ten acquisitions to cover entire head.
Gantry	Floor mounted, standard gantry tilts up to 30°. Optional gantry tilts to 45°.	Suspended from ceiling, gantry can tilt up to 45°.
Patient Position	Seated or Supine. Optional chair insert for children.	Seated or Lying on back or side.
Head Position Indicator	Available	Available
Computer	Hewlett Packard workstation with UNIX environment.	SUN workstation with the UNIX environment
Networking Capabilities	Ethernet connections to other workstations available	Ethernet connections to other workstations available
Magnetic Shielded Room Accessories	Video monitor and two-way intercom for monitoring patients.	Interior DC lights, video cameras, and two-way intercom for monitoring patients
Intended Use	Non-invasively detects and displays biomagnetic signals produced by electrically active nerve tissue in the brain. Data enhances diagnostic capability by providing useful information about the location relative to brain anatomy of active nerve tissue responsible for critical brain functions.	Non-invasively detects small biomagnetic signals produced by the brain and provides information about the location of electrically active nerve tissue responsible for producing these signals. Data presented to physicians in an MEG image from which they may draw information about the location of critical brain functions relevant to brain anatomy.

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 does not describe a test set or clinical study with a specific sample size. The substantial equivalence argument relies on comparing the technical specifications and intended use of the Neuromag-122 to a legally marketed predicate device. No patient data, therefore, is mentioned for any "test set".

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)

Not applicable. As noted above, no clinical "test set" and corresponding ground truth establishment are described in this document. The "ground truth" for the device's function is the established performance and safety of the predicate device.

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

Not applicable. No clinical test set or adjudication method is described.

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

Not applicable. This document is for a medical device (MEG system) and not an AI or imaging diagnostic software that would typically undergo an MRMC study.

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

Not applicable. The Neuromag-122 is a hardware system for detecting biomagnetic signals, not a standalone algorithm. Its intended use explicitly states that the data needs to be "interpreted by a trained clinician."

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

The document implicitly uses the established safety and effectiveness of the predicate device (Biomagnetic Technologies Magnes Single, K901215A) as its "ground truth" or standard for comparison. The regulatory review for substantial equivalence primarily relies on a comparison of technological characteristics, intended use, and existing performance data of the predicate device.

8. The sample size for the training set

Not applicable. This document does not describe a machine learning algorithm that would require a training set.

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

Not applicable. As above, no training set or its ground truth establishment is mentioned.

Summary

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OCT 31 1986

Image /page/0/Picture/1 description: The image shows a sequence of handwritten characters and numbers. The sequence appears to be 'K962764'. The characters are written in a bold, dark font, which makes them easily readable against the white background. The style of writing suggests a casual or informal context.

SUMMARY OF SAFETY AND EFFECTIVENESS (As required by 21 CFR 807.92)

General Information 1.

Classification:	Class IIMagnetoencephalograph
Common/Usual Name:	Magnetoencephalographic (MEG) Device
Proprietary Name:	Neuromag-122
Establishment Registration:	Manufacturer:Neuromag Ltd.P.O. Box 35700511 Helsinki, FinlandPhone: +358-0-394 101Fax: +358-0-3941 203FDA Facility Registration: # 9680891United States Representative:Picker International, Inc.595 Miner RoadHighland Heights, OH 44143FDA Owner Number: #1580240
Performance Standards	No applicable performance standards have beenissued under section 514 of the Food, Drug andCosmetic Act.

2. Intended Uses

3. Device Description

PICKER INTERNATIONAL, INC.	(MSD)	7/15/96
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gives the user the ability to record the electrical activity of the entire surface of the brain simultaneously without having to move the position of the probe.

Safety and Effectiveness 4.

The Neuromag-122 is substantially equivalent to the Biomagnetic Technologies Magnes Single (K901215A) in safety and effectiveness. The following chart has been compiled to demonstrate Neuromag-122's substantial equivalence to this device.

Parameter	Neuromag-122	Biomagnetic TechnologiesMagnes Single (K901215A)
No. of SQUID detectors /channels for MEG data	122	37
No. of auxiliary channels forother types of data (e.g EEG)	166(typically use 32 for EEG)	51
Gradiometer	Two orthogonal planar-first-order gradiometers perlocation	First order axial gradiometer
Intersensor spacing	43-44 mm	20 mm
Gradiometer placement	Sixty-one locationsdistributed across helmet-shaped lower tip of dewar.Radius of curvature of helmetis 83 mm (front-portion) and91 mm (back-portion).	Positioned in a circular array(diameter 14.4 cm) over aconcave spherical surfacewith a 12.2 cm radius ofcurvature.
Cryogen Used	Liquid Helium	Liquid Helium
Coverage	One acquisition to coverentire head	Six to ten acquisitions tocover entire head.
Gantry	Floor mounted, standardgantry tilts up to 30°.Optional gantry tilts to 45°.	Suspended from ceiling,gantry can tilt up to 45°.
Patient Position	Seated or Supine. Optionalchair insert for children.	Seated or Lying on back orside.
Head Position Indicator	Available	Available

SUBSTANTIAL EQUIVALENCE CHART

PICKER INTERNATIONAL, INC.

(MSI)

ﮯ

7/15/96

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Computer	Hewlett Packard workstationwith UNIX environment.	SUN workstation with theUNIX environment
Networking Capabilities	Ethernet connections to otherworkstations available	Ethernet connections to otherworkstations available
Magnetic Shielded RoomAccessories	Video monitor and two-wayintercom for monitoringpatients.	Interior DC lights, videocameras, and two-wayintercom for monitoringpatients
Intended Use	Based on the product literature: The Magnes Single non-invasively detects small biomagnetic signals produced by thebrain and provides information about the location ofelectrically active nerve tissue responsible for producing thesesignals. The data is presented to the physicians in an MEGimage, from which they may draw information about thelocation of critical brain functions relative to brain anatomy.	The Neuromag-122 system is intended for use as a magnetoencephalographic (MEG) device which non-invasively detectsand displays biomagnetic signals produced by electricallyactive nerve tissue in the brain. When interpreted by a trainedclinician, the data enhances the diagnostic capability byproviding useful information about the location relative tobrain anatomy of active nerve tissue responsible for criticalbrain functions.

7/15/96

I-3

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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circle around the eagle. The eagle is facing to the right, and its wings are curved upwards. The logo is simple and clean, and it is easily recognizable.

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

Elaine K. Keeler, Ph.D. Picker International, Inc. 5500 Avion Park Drive Highland Heights, Ohio 44143

Re: K962764 Trade/Device Name: Neuromag-122 Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: II Product Code: OLY, OLT Dated (Date on orig SE ltr): October 11, 1996 Received (Date on orig SE ltr): October 15, 1996 APR - 9 2012

Dear Ms. Keeler:

This letter corrects our substantially equivalent letter of October 31, 1996.

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, listing 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.

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Page 2 - Ms. Elaine K. Keeler

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/ReportalProblem/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/Industry/default.htm.

Sincerely yours.

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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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Page 1 of 1

510(k) Number (if known): K9112764

Device Name: Neuromag-122

Indications for Use:

The Neuromag-122 system is intended for use as a magneto encephalographic (MEG) device which non-invasively detects and displays biomagnetic signals produced by electrically active nerve tissue in the brain. When interpreted by a trained clinician, the data chhances the diagnostic capability by providing useful information about the location relative to brain anatomy of active nerve tissue responsible for critical brain functions.

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

Concurrence of CDRH/Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number	K962764

Prescription Use (Per 21 CFR 801.109)	OR	Over-The-Counter Use (Optional Format 1-2-96)
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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).