The software is intended for use by a trained/qualified EEG technologist or physician on both adult and pediatric subjects at least 16 years of age for the visualization of human brain function by fusing a variety of EEG information with rendered images of an idealized head model and an idealized MRI image.

Device Description

Sourcerer is an EEG source localization software that uses EEG and MRI-derived information to estimate and visualize cortex projections of human brain activity. Sourcerer is designed in a client-server model wherein the server components integrate directly with FLOW - BEL's software. Inverse source projections are computed on the server using EEG and MRI data from FLOW using the Electro-magnetic Inverse Module (EMIM API). The inverse results are interactively visualized in the Chrome browser running on the client computer using the Electro-magnetic Functional Anatomy Viewer (EMFAV).

AI/ML Overview

Here's an analysis of the provided text to extract the acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Algorithmic Testing (HexaFEM)
Consistency with analytical solutions for three-layer spherical model	HexaFEM solutions are consistent with the analytical solutions for the three-layer spherical model.
Consistency with FDM solutions for a realistic head model using the same conductivity values	HexaFEM and FDM solutions are the same for one realistic head model using the same conductivity values.
Algorithmic Testing (Inverse Model - EMIM Module)
LORETA: Localization error distance similar to reported values by its creator.	Average localization error is about 7 mm, similar to what is reported for LORETA from its creator.
sLORETA: Exact source estimation results for simulated signal sources, replicating creator's reported results.	Source estimation results are exact for the simulated signal sources, fully replicating simulated results reported by sLORETA's creator.
MSP: Zero localization error for simulated signal sources.	Shows 100% (zero localization error), as expected.
Clinical Performance Testing
Performance of Sourcerer to be equivalent to GeoSource (Predicate Device).	Performance of Sourcerer was shown to be equivalent to GeoSource (comparison based on Euclidian distance between maximal amplitude location and resected boundary in epileptic patients).
Software Verification and Validation Testing
Accuracy of Sourcerer validated through algorithm testing.	Algorithm testing validated the accuracy of Sourcerer. Product deemed fit for clinical use.
Developed according to FDA's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Device".	Sourcerer was designed and developed as recommended by the FDA guidance.
Safety classification set to Class B according to AAMI/ANSI/IEC 62304 Standard.	Sourcerer safety classification set to Class B.
"Basic Documentation Level" applied.	"Basic Documentation Level" applied to this device.

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

The text explicitly mentions:

Clinical Performance Testing: "The clinical data used in the evaluation is obtained from epileptic patients during standard presurgical evaluation." The sample size for the clinical test set is not explicitly stated as a number, but rather as "each patient's pre-operative hdEEG recording." It's implied there were multiple patients, but the exact count is missing.
Data Provenance: The clinical data is retrospective ("obtained from epileptic patients during standard presurgical evaluation") and appears to be from a clinical setting, presumably within the country of origin of the device manufacturer (USA, as indicated by the FDA submission).

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

Clinical Performance Testing Ground Truth: The ground truth for the clinical test set was established by:
- Resected region (from MRI): This implies surgical and pathological confirmation of the epileptic zone, which would typically involve neurosurgeons and neuropathologists.
- Clinical outcome: This refers to the patient's post-surgical seizure control, indicating the success of the resection.
  No specific number of experts or their qualifications (e.g., number of years of experience) are provided in the document.

4. Adjudication method for the test set

The document does not explicitly describe an adjudication method for establishing ground truth, such as 2+1 or 3+1. The ground truth for the clinical performance testing relied on the "resected region (from MRI)" and "clinical outcome," which are objective clinical findings rather than subjective expert interpretations requiring 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

There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study. The clinical performance testing compared the device's output (Electrical Source Imaging - ESI) to the predicate device (GeoSource) and the ground truth (resected region, clinical outcome), not improved human reader performance with AI assistance.

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

Yes, extensive standalone (algorithm only) performance testing was done:

Algorithmic Testing of HexaFEM: Compared HexaFEM solutions to analytical solutions and FDM solutions.
Algorithmic Testing of Inverse Model (EMIM Module): Tested LORETA, sLORETA, and MSP solvers using "test files with known signal sources." This involved comparing the algorithm's estimated source generator to the known (simulated) source.

7. The type of ground truth used

Algorithmic Testing (HexaFEM):
- Mathematical/Analytical Ground Truth: Comparison with "analytical solutions for the three-layer spherical model."
- Comparative Ground Truth: Comparison with "FDM solutions for one realistic head model."
Algorithmic Testing (Inverse Model - EMIM Module):
- Simulated/Known Ground Truth: "known signal sources" from forward projections were used as ground truth for "recovering the source generator (known)."
Clinical Performance Testing:
- Outcomes Data/Pathology/Clinical Consensus: "resected region (from MRI)" and "clinical outcome" were used to establish the ground truth for epileptic focus localization.

8. The sample size for the training set

The document does not specify the sample size for the training set. It focuses on verification and validation, but not the training of the underlying algorithms.

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

Since the document does not specify the training set, it does not describe how its ground truth was established. The ground truth description is primarily for the test/validation sets.

Summary

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September 27, 2024

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Brain Electrophysiology Laboratory Company, LLC Phan Luu Chief Scientist 1776 Millrace Drive Suite 304 Eugene, Oregon 97403

Re: K241513

Trade/Device Name: Sourcerer Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: OLX Dated: August 28, 2024 Received: August 28, 2024

Dear Dr. Luu:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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).

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Sincerely,

Jay R. Gupta -S

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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Indications for Use

510(k) Number (if known) K241513

Device Name Sourcerer

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)
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510(K) Summary

1. SUBMITTER
Submitter Name:Address:Phone Number:Contact Person:Date Prepared:	Brain Electrophysiology Laboratory Company, LLC1776 Millrace Drive, Eugene, OR 97403541-653-9797Dr. Phan LuuJune 10 2024
2. DEVICE
Device Trade Name:Common Name:Classification Name,Number &Product Code:Class:Classification Panel:	SourcererElectroencephalograph SoftwareElectroencephalograph21 CFR 882.1400OLXIINeurology
3. PREDICATE DEVICES
Primary Predicate Device:Intended use:	K092844GeoSource is intended for use by atrained/qualified EEG technologist or physician onboth adult and pediatric subjects at least 3 years ofage for the visualization of human brain function byfusing a variety of EEG information with renderedimages of an idealized head model and anidealized MRI image.

4. DEVICE DESCRIPTION

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FLOW's web server, from which the client computer can make requests when opening an MFF file using Sourcerer.

Image /page/5/Figure/3 description: The image shows a diagram of a system with three main components: EMFAV, FLOW, and EMIM API. EMFAV, located on the Client Computer, handles display methods such as Scalp, Cortical, Dipoles, Flat Map, and Butterfly Plot. FLOW, situated on the Server, manages User Authentication, MFF Files, Experiments, and Atlas Head Models, while EMIM API, also on the Server, provides Inverse Algorithms like sLORETA, LORETA, MSP, and Spectral, illustrating the data flow and interactions between these components.

Figure 1. Architecture Overview of Sourcerer. Sourcerer is divided into three software components shown in green: EMFAV, EMIM API, and Atlas Head Models.

5. INDICATIONS FOR USE

6. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH PREDICATE DEVICE

	New Device	Primary Predicate Device
Device name	Sourcerer	GeoSource
510(k) number		K092844
Manufacturer	Brain ElectrophysiologyLaboratory Company LLC	EGI
Regulation	882.1400	882.1400
Product Code	OLX	OLX
DeviceClassificationName	Class II	Class II
Software onlyproduct	Yes	Yes

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Computer OS	MS-windows 7, Mac OS, Linux. Iscloud based and relies on webbrowser for user interface.	Mac OS
MRI visualization	Idealized MRI (average)	Idealized MRI (average)
Source estimationmethods:		sLORETA,LORETA,LAURA
Linear inversemethods
Forward headmodeling	Finite Element Method(FEM).Tissues and respectiveconductivities (S/m)include:air = 0.0CSF = 1.6eyes = 1.55skull = 0.006scalp = 0.3,gray matter = 0.45white matter = 0.2	Sphere, Finite DifferenceModel (FDM). Tissuesand respectiveconductivities (S/m)include:air = 0.0CSF = 1.79eyes = 1.55skull = 0.01scalp = 0.33gray matter = 0.25white matter = 0.35

Table 1: Comparison of the new device to the predicate device

Summary ofTechnologicalCharacteristics	Inputs: Sourcerer takes as inputs hdEEG data.Electrical Head Models: Sourcerer uses idealized (i.e., atlas) headmodels to describe current flow from cortex to scalp, where the EEGis recorded.Conductivity values: Sourcerer use different conductivity values foreach of the different head tissues.Forward model: Sourcerer uses the Finite Element Method (FEM) toderive forward model.Inverse Methods: Sourcerer uses the LORETA, sLORETA and MultipleSparse Priors (MSP) inverse methods.Display: Sourcerer displays the results on idealized head models
SubstantialEquivalenceComparison	The identified equivalent device is GeoSource K092844. GeoSource isequivalent and different to Sourcerer in the following ways:● Like GeoSource, Sourcerer takes as inputs hdEEG data.● Electrical Head Models: Like Sourcerer, GeoSource usesidealized (i.e., atlas) head models to describe current flowfrom cortex to scalp, where the EEG is recorded. Atlas headmodels for both Sourcerer and Geosource characterize the

Summary ofTechnologicalCharacteristics

Inputs: Sourcerer takes as inputs hdEEG data.Electrical Head Models: Sourcerer uses idealized (i.e., atlas) headmodels to describe current flow from cortex to scalp, where the EEGis recorded.Conductivity values: Sourcerer use different conductivity values foreach of the different head tissues.Forward model: Sourcerer uses the Finite Element Method (FEM) toderive forward model.Inverse Methods: Sourcerer uses the LORETA, sLORETA and MultipleSparse Priors (MSP) inverse methods.Display: Sourcerer displays the results on idealized head models

SubstantialEquivalenceComparison

The identified equivalent device is GeoSource K092844. GeoSource isequivalent and different to Sourcerer in the following ways:● Like GeoSource, Sourcerer takes as inputs hdEEG data.● Electrical Head Models: Like Sourcerer, GeoSource usesidealized (i.e., atlas) head models to describe current flowfrom cortex to scalp, where the EEG is recorded. Atlas headmodels for both Sourcerer and Geosource characterize the

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same brain tissues: scalp, skull, eyeballs, air, cerebral spinal fluid, gray matter and white matter.

Sourcerer and GeoSource use different conductivity values for each of the different head tissues (detailed below).
Another difference between Sourcerer and GeoSource atlas head models is the way in which the forward model (i.e., how current flow is modeled) is computed. Sourcerer uses the Finite Element Method (FEM) whereas GeoSource uses the Finite Difference Method (FDM) and spherical model (which is not relevant for the present evaluation).
Inverse Methods: Like Sourcerer, GeoSource uses the LORETA and sLORETA inverse methods. However, Sourcerer includes an additional inverse method (Multiple Sparse Priors—MSP) not supported by GeoSource.
Display: Like Sourcerer, GeoSource displays the results on idealized head models.

7. PERFORMANCE DATA

Algorithmic testing of HexaFEM and Inverse methods

HexaFEM

HexaFEM is the computational modeling method used to compute current flow from a position on the cortex through the various head tissues in the Sourcerer device.

Comparison of a three-layer sphere between HexaFEM and Spherical Analytics showed that the HexaFEM solutions are consistent with the analytical solutions for the three-layer spherical model.

HexaFEM and FDM Results

Similar to the three-layer sphere analytics, we compared the HexaFEM and FDM solutions for one realistic head model using the same conductivity values. Results showed that the HexaFEM and the FDM solutions are the same.

Inverse Model (EMIM Module)

The inverse solvers were tested using test files with known signal sources. The known signals are from the forward projection, using an atlas head model, of current from each dipole to the scalp. The scalp data from the forward projections signals, with no noise added per standard procedure from scientific literature, were then used to recover the source generator (known) with the various inverse solvers.

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	Results are quantified as localization error distance (i.e., distance of the source estimate from the original source generating the scalp signal).
	LORETA: The average localization error is about 7 mm. The localization error distance is similar to what is reported for LORETA from the creator of LORETA.
	sLORETA Source estimation results are exact for the simulated signal sources. This fully replicates the simulated results reported by the creator of sLORETA.
	MSP The results show 100% (zero localization error), as expected.
ClinicalPerformanceTesting	The clinical data used in the evaluation is obtained from epileptic patients during standard presurgical evaluation. The data from the clinical assessment used in the current clinical evaluation are hdEEG (256 channels) data, resected region (from MRI) and clinical outcome. The hdEEG data allow for Electrical Source Imaging (ESI) to be performed, the resected region provides an anatomic location to compare the ESI results, and the clinical outcome provides assurance that the resected location can be trusted as a ground-truth location.ESI was performed on an average inter-ictal spike derived from each patient's pre-operative hdEEG recording in both Sourcerer and Geosource. For each patient, the Euclidian distance between the location of maximal amplitude and the nearest voxel of the resected boundary was calculated for both devices.Performance of Sourcerer was shown to be equivalent to GeoSource.
SoftwareVerification andValidation Testing	Validation testing involved algorithm testing which validated the accuracy of Sourcerer. The product was deemed fit for clinical use. Sourcerer was designed and developed as recommended by FDA's Guidance, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Device". According to AAMI/ANSI/IEC 62304 Standard, Sourcerer safety classification has been set to Class B. "Basic Documentation Level" applied to this device.

8. CONCLUSION

The information discussed above and provided in the 510(k) submission demonstrate that the Sourcerer device is substantially equivalent to the predicate.

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).