The RICOH MEG non-invasively measures the magnetoencephalographic (MEG) produced by electrically active tissue of the brain. These signals are recorded by a computerized data acquisition system, displayed, and may then be interpreted by trained physicians to help localize these active areas. The locations may then be correlated with anatomical information of the brain. MEG is routinely used to identify the locations of visual, auditory, and somatosensory activity in the brain when used in conjunction with evoked response averaging devices. MEG is also used to non-invasively locate regions of epilentic activity within the brain. The localization information provided by the device may be used, in conjunction with other diagnostic data, as an aid in neurosurgical planning.

Device Description

The RICOH MEG Analysis is an analysis software package used for processing and analyzing MEG data. It displays digitized MEG signals, EEG signals, topographic maps, and registered MRI images. Universal functions such as data retrieval, storage, management, querying and listing, and output are handled by the basic MEGvision Software of Eagle Technology, Inc. (K040051).

The RICOH MEG Analysis is designed to aid clinicians in the assessment of patient anatomy, physiology, electrophysiology and pathology and to visualize source localization of MEG signals.

AI/ML Overview

The provided document describes the RICOH MEG, a magnetoencephalograph (MEG) device, and its acceptance criteria and the study performed to demonstrate conformance.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Test Name	Acceptance Criteria (Purpose of Testing)	Reported Device Performance (Summary of results)
[1] Matching Module design test	Verify that the Matching Module meets the design specifications by a black box test, including image correction and alignment techniques of co-registration to MRI/3D digitizer data.	Satisfied the pass/fail criteria. Pass. (Planned test cases: 39; Tested cases: 39; Failures occurred: 0; Failures corrected: 0)
[2] Analysis System design test	Verify that the Analysis System meets the design specifications by a black box test. Verify that the updated function does not affect the continued performance of the rest of the device.	Satisfied the pass/fail criteria. Pass. (Planned test cases: 20; Tested cases: 20; Failures occurred: 0; Failures corrected: 0)
[3] Analysis System Validation	Perform validation by a person who can substitute the intended user (operates without training, has knowledge to instruct users). Validate product validity, usability validity, and software validity based on the Intended Use.	Pass/Fail: Pass.

2. Sample size used for the test set and the data provenance:

Sample Size: The document does not specify a "test set" in terms of patient data or number of cases for the performance evaluation. Instead, it refers to "test cases" for software verification and validation.
- Matching Module design test: 39 test cases.
- Analysis System design test: 20 test cases.
- Analysis System Validation: No specific number of cases is provided, but it states "performance the validation by a person who can substitute the intended user."
Data Provenance: Not specified for any biological or clinical data. The tests described are bench tests and software verification/validation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

The document primarily describes engineering/software verification and validation tests rather than clinical performance evaluation requiring expert ground truth.
For the "Analysis System Validation," it states that the validation was performed by "a person who can substitute the intended user," characterized as someone who can "operate the product without training" and has "the knowledge to be able to instruct the user on the operation of the product." This individual acts as a proxy for an expert user, but their specific qualifications (e.g., years of experience, medical specialty) are not detailed.

4. Adjudication method for the test set:

Not applicable. The tests described are focused on functional and design specification verification through pass/fail criteria for engineered systems, not on clinical interpretation requiring expert adjudication.

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:

No, a multi-reader, multi-case comparative effectiveness study with or without AI assistance was not done. The device is a MEG system for measuring brain activity and aiding in localization, not an AI-assisted diagnostic tool in the typical sense of needing reader performance comparisons.

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

The RICOH MEG is a device that records and processes MEG signals. The "RICOH MEG Analysis" is an analysis software package used for processing and analyzing MEG data. It displays signals and visualizes source localization. The document states that signals "may then be interpreted by trained physicians." This indicates that human interpretation is an integral part of its intended use. Therefore, a standalone algorithm-only performance study without human-in-the-loop is not described as relevant or performed given the nature of the device.

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

For the described tests, the "ground truth" is primarily based on design specifications and functional requirements for the software modules. For example, verifying that the Matching Module performs image correction and alignment according to its design.
For "Analysis System Validation," the ground truth for "product validity, usability validity, and software validity" is established by a qualified individual (a "substitute for the intended user") assessing whether the system meets its intended purpose. No external clinical "ground truth" (e.g., pathology, outcomes data) is referenced for these specific performance tests.

8. The sample size for the training set:

Not applicable. The document describes a medical device and its associated software for MEG data analysis. It does not mention any machine learning or AI components that would require a "training set" in the context of developing a diagnostic algorithm.

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

Not applicable, as no training set for an AI/ML algorithm is mentioned.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The FDA text logo is in blue and includes the acronym "FDA" in a square, followed by "U.S. FOOD & DRUG ADMINISTRATION" in two lines.

July 2, 2021

RICOH COMPANY, Ltd.

Satoshi Yuuki Specialist 2-3, Hokuyodai Kanazawa-shi, Ishikawa 920-0177 Japan

Re: K210199

Trade/Device Name: RICOH MEG Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: OLX, OLY Dated: May 17, 2021 Received: May 26, 2021

Dear Satoshi Yuuki:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

for Jay Gupta Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known) K210199

Device Name RICOH MEG

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

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This 510(k) summary is prepared in accordance with 21 CFR 807.92.

I. Submitter Information

Name:	RICOH COMPANY, Ltd.
Address:	2-3, Hokuyodai, Kanazawa-shi, Ishikawa 920-0177 Japan
Phone:	+81-76-258-7012
Facsimile:	+81-76-258-7026
Contact Person:	Satoshi Yuuki
E-Mail:	satoshi.yuuki@jp.ricoh.com
Date:	Jan 12 2021

II. Device

Trade Name:	RICOH MEG
Common Name:	Magnetoencephalograph (MEG)
Classification Name(s):	Electroencephalograph
Regulation numbers:	21 CFR 882.1400
Primary product code:	OLX
Secondary product code:	OLY
Device class:	II

III. Predicate Device(s)

Device Name	510(k) No.	Manufacturer
MEGvision,EQ1000C Series	K040051	Eagle Technology, Inc.
Elekta Neuromag	K041264	Elekta Neuromag Oy

Device Description IV.

The RICOH MEG Analysis is designed to aid clinicians in the assessment of patient anatomy, physiology, electrophysiology and pathology and to visualize source localization of MEG signals.

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v. Indications For Use

The RICOH MEG non-invasively measures the magnetoencephalographic (MEG) by electrically active tissue of the brain. These signals are recorded by a computerized data acquisition system, displayed, and may then be interpreted by trained physicians to help localize these active areas. The locations may then be correlated with anatomical information of the brain. MEG is routinely used to identify the locations of visual, auditory, and somatosensory activity in the brain when used in conjunction with evoked response averaging devices. MEG is also used to non-invasively locate regions of epileptic activity within the brain. The localization information provided by the device may be used, in conjunction with other diagnostic data, as an aid in neurosurgical planning.

VI. Comparison of Technological Characteristics with the Predicate Devices

At a high level, the following technological differences exist between the subject and predicate devices:

Use of a third party digitizer to provide additional method of co-registering MRI and MEG data;
Number of auxiliary channels for other types of data (i.e., addition of cables and ● interface allowing subject device to receive and send digital EEG signals);
. Removal of evoked mode recording with post averaging:
. Updated display to show EEG time series at corresponding latency (if EEG data simultaneously acquired);
. Addition of DICOM data output with information regarding magnetic field anlaysis

Feature	RICOH COMPANY, LTD.RICOH MEG	EAGLE TECHNOLOGY, INC.MEGvision EQ1000C Series(K040051)	SE DeviceElekta Neuromag OyElekta Neuromag(K041264)
IntendedUse	The RICOH MEG is intendedfor use as amagnetoencephalographic(MEG) device which non-invasively detects and displaysbiomagnetic signals producedby electrically active nervetissue in the brain. Wheninterpreted by a trainedclinician, the data enhances thediagnostic capability byproviding useful informationabout the location relative tobrain anatomy of active nervetissue responsible for criticalbrain functions.	The MEGvision non-invasively measures themagnetoencephalographic(MEG) signals produced by theelectrical activities by the tissueactivities of the brain. Thesesignals, position, direction, andsensitivity of the sensors areacquired and displayed, andmay be interpreted by trainedclinicians to help localize theseactive areas. The locations maybe correlated to anatomicalstructure of the brain.	The Elekta Neuromag TM isintended for use as amagnetoencephalographic(MEG) device which non-invasively detects anddisplays biomagnetic signalsproduced by electricallyactive nerve tissue in thebrain. When interpreted by atrained clinician, the dataenhances the diagnosticcapability by providing usefulinformation about the locationrelative to brain anatomy ofactive nerve tissueresponsible for critical brainfunctions.

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Feature	RICOH COMPANY, LTD.RICOH MEG	EAGLE TECHNOLOGY, INC.MEGvision EQ1000C Series(K040051)	SE DeviceElekta Neuromag OyElekta Neuromag(K041264)
Indicationsfor use	The RICOH MEG non-invasively measures themagnetoencephalographic(MEG) produced by electricallyactive tissue of the brain. Thesesignals are recorded by acomputerized data acquisitionsystem, displayed, and maythen be interpreted by trainedphysicians to help localize theseactive areas. The locations maythen be correlated withanatomical information of thebrain. MEG is routinely used toidentify the locations of visual,auditory, and somatosensoryactivity in the brain when usedin conjunction with evokedresponse averaging devices.MEG is also used to non-invasively locate regions ofepileptic activity within thebrain. The localizationinformation provided by thedevice may be used, inconjunction with otherdiagnostic data, as an aid inneurosurgical planning.	The MEGvision is intended foruse as amagnetoencephalographic(MEG) device which non-invasively detects and displaysbiomagnetic signals producedby electrically active nervetissue in the brain. Wheninterpreted by a trainedtechnician, the data enhancesthe diagnostic capability byproviding useful informationabout the location relative tobrain anatomy of active nervetissue responsible for criticalbrain functions.	The Elekta NeuromagTM non-invasively measures themagnetoencephalographic(MEG) signals (and,optionally,electroencephalographic(EEG) signals) produced byelectrically active tissue of thebrain. These signals arerecorded by a computerizeddata acquisition system,displayed, and may then beinterpreted by trainedphysicians to help localizethese active areas. Thelocations may then becorrelated with anatomicalinformation of the brain.MEG is routinely used toidentify the locations ofvisual, auditory,somatosensory, and motorcortex in the brain when usedin conjunction with evokedresponse averaging devices.MEG is also used to non-invasively locate regions ofepileptic activity within thebrain. The localizationinformation provided byMEG may be used, inconjunction with otherdiagnostic data, inneurosurgical planning.
Feature	RICOH COMPANY, LTD.RICOH MEG	EAGLE TECHNOLOGY, INC.MEGvision EQ1000C Series(K040051)	SE DeviceElekta Neuromag OyElekta Neuromag(K041264)
Number ofSQUIDdetectors/channels forMEG data	64 to 320	64 to 320	306
OperatingPrinciple	dc SQUID	dc SQUID	dc SQUID
Number ofauxiliarychannels forother typesof data	-16 ADC channels-Up to 128 EEG channels (EEGsystem is independent of theMEG system).	Up to 166 ADC channels	Up to 124 unipolar and 4bipolar EEG channels.Up to 8 ADC channels.
Pickup CoilDesign	1 axial first order gradiometerper location	1 axial first order gradiometerper location	Mix of planar gradiometersand magnetometers
Intersensorspacing	20mm to 25mm(160 sensor configuration)	20mm to 25mm(160 sensor configuration)	34 mm average distancebetween centers of eachsensing location.
Gradiometerplacement	64 to 320	64 to 320	102
Cryogenused:	Liquid helium	Liquid helium	Liquid helium
Coverage	Whole cortex	Whole cortex	Whole cortex
Gantry	Floor mounted fixed gantry	Floor mounted fixed gantry	Floor mounted, standardgantry. The gantry has twofixed, predefined, tilt anglescorresponding to supine andupright measurementpositions.
PatientPosition	Supine	Supine	Supine and upright
HeadPositionIndicator(HPI)	Included	Included	Included
Computer	Personal computer withWindows OS	Personal computer withWindows OS	HP workstation with UNIXOS
NetworkingCapabilities	Ethernet connections to othernetwork system available	Ethernet connections to othernetwork system available	Ethernet connections to othernetwork system available
Magnetically ShieldedRoomAccessories	Interior DC lights, video cameraand two-way intercom forpatients	Interior DC lights, video cameraand two-way intercom forpatients	Interior DC lights, videocamera and two-way intercomfor patients
Coregistration of MEGdata to MRIdata	A method based on the methodof picking up the position of theHPI coils from the MRI images.A method based on the methodusing the position of the HPIcoils and the anatomicallandmarks on the head, whichmeasured by a 3D digitizer.	A method based on the methodof picking up the position of theHPI coils from the MRI images.	A method based on themethod using the position ofthe HPI coils and theanatomical landmarks on thehead, which measured by a3D digitizer.
Site ofpatient	Head and Scalp	Head and Scalp	Head and Scalp
OverallSensitivity	10fT/ $\sqrt{\text{Hz}}$	10fT/ $\sqrt{\text{Hz}}$	10fT/ $\sqrt{\text{Hz}}$
Feature	RICOH COMPANY, LTD.RICOH MEG	EAGLE TECHNOLOGY, INC.MEGvision EQ1000C Series(K040051)	SE DeviceElekta Neuromag OyElekta Neuromag(K041264)
SQUIDReadout	Flux locked loop	Flux locked loop	Flux locked loop
OfflineAverageFunction toProcessRaw Data	Yes	Yes	Yes
Method ofCalculation/ Forwardhead model(i.eidealized v.individualhead model)	Spherical conductor model foridealized head shapes.	Spherical conductor model foridealized head shapes.	Spherical conductor modelfor idealized head shapes.Individual realistic headmodels using the BoundaryElement Method (BEM).
SourceEstimateMethods /Inversehead model	Equivalent Current Dipole(ECD) for clinical analysis.Single- and multi-dipole timevarying source estimates.	Equivalent Current Dipole(ECD) for clinical analysis.Single- and multi-dipole timevarying source estimates.	Equivalent Current Dipole(ECD) for clinical analysis.Single- and multi-dipole timevarying source estimates.
PatientPopulation	Adult	Adult	Adult
PowerSource	Mains power	Mains power	same
DataAcquisition	Inbuilt	Inbuilt	Inbuilt

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VII. Performance Data

The following performance data were provided in support of the substantial equivalence determination.

Software verification and validation in accordance with IEC62304; •
. Bench testing (see below)

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Bench test	Purpose of Testing	Remark	Summary of results
[1]MatchingModuledesign test	Verify that the MatchingModule meets the designspecifications by a black boxtest.	Test using MEG systemVerify that the MatchingModule meets moduledesign specificationsregardinge image correction andalignment techniques of co-registration to MRI/3Ddigitizer data.	Satisfied the pass / failcriteria. Pass.Planned testcases :39 Testedcases :39Failures occurred :0Failures corrected :0
[2] AnalysisSystemdesign test	Verify that the Analysis Systemmeets the design specificationsby a black box test.	Test using MEG systemVerify that the updatedfunction does not affect thecontinued performance of therest of our device.	Satisfied the pass / failcriteria. Pass.Planned testcases :20 Testedcases :20Failures occurred :0Failures corrected :0
[3] AnalysisSystemValidation	Perform the validation by aperson who can substitute theintended user.Substitutes: Person in chargeof validation. *A person whocan operate the product withouttraining. A person who has theknowledge to be able to instructthe user on the operation of theproduct.Provision of training: notraining is required prior to theevaluation and therefore willnot be conducted.Method of collection ofvalidation records: the personin charge of validation validatesand records according to theimplementation.	Test using MEG systemValidate product validity,usability validity, andsoftware validity based on theIntended Use.	Pass/FailDescription: Pass

VIII. Conclusions

Given the modifications made to the device, bench testing was performed to support substantial equivalence. The non-clinical data provided demonstrate that the device should perform as intended in the specified use conditions, and that the device performs comparably to the predicate devices that are currently marketed for the same intended use. In addition, potential hazards have been addressed by the Risk Management process to ensure risk mitigation during use of the device.

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).