The NeuroOne Cortical Electrodes are intended for temporary (less than 30 days) use with recording, monitoring, and stimulation equipment for the recording, monitoring, and stimulation of electrical signals on the surface of the brain.

Device Description

The NeuroOne Cortical Electrode is a sterile, single use electrical conductor that is temporarily placed (< 30 days) on the surface of the brain. The electrodes are designed to record and/or monitor the brain's electrical activity as well as stimulate the brain. It consists of a series of contacts mounted in thin plastic strips, or in a square/rectangular grid to cover larger surface areas. The device is connected to recording, monitoring, or stimulation/response instrumentation currently commercially available for use with other cortical electrodes, including the predicate device.

AI/ML Overview

The provided text is a 510(k) summary for the NeuroOne Cortical Electrode. This document outlines the device's characteristics and compares it to a predicate device to establish substantial equivalence, which is a regulatory pathway for medical device clearance. It does not contain information about a study proving the device meets acceptance criteria in the context of a standalone or comparative effectiveness clinical study with performance metrics like sensitivity, specificity, or F1-score.

Instead, the "acceptance criteria" discussed here refer to the regulatory requirements for demonstrating equivalence to a legally marketed predicate device. The "study" proving acceptance criteria is a series of engineering and biocompatibility tests intended to show that the differences between the new device and the predicate do not raise new questions of safety or efficacy.

Therefore, I cannot provide a table of acceptance criteria and reported device performance in the format typically used for studies evaluating diagnostic or predictive AI systems, nor can I answer questions related to sample size for test sets, ground truth establishment by experts, adjudication methods, or MRMC studies. These elements are not applicable to the type of regulatory submission described.

Here's a breakdown of what can be extracted from the document regarding the criteria and the "study" (testing) that supports the device:

1. A table of acceptance criteria and the reported device performance:

The acceptance criteria are implicitly defined by the benchmarks set by the predicate device and relevant international standards. The "reported device performance" refers to the successful completion of various tests deemed sufficient to demonstrate equivalence.

Acceptance Criteria (Implicit from Predicate & Standards)	Reported Device Performance (Summary of Testing)
Premarket Requirements (Regulatory Substantial Equivalence):
Same Indications for Use	Achieved (stated explicitly)
Same Intended Use	Achieved (stated explicitly)
Used in the same anatomical site	Achieved (stated explicitly)
Uses similar technological characteristics	Achieved (bench testing)
Uses same principles of operation	Achieved (stated explicitly)
Uses same sterilization methodology	Achieved (stated explicitly)
Biocompatible for its intended use	Achieved (Biocompatibility Testing)
Device Performance (Engineering & Biocompatibility):
Dimensional conformance	Design Verification Testing (Dimensional Measurements)
Durability	Design Verification Testing (Durability)
Mapping/Stimulation capability	Design Verification Testing (Mapping/Stimulation)
Reliability	Design Verification Testing (Reliability)
Electrical safety & performance	Electrical testing to IEC 60601
Biocompatibility	Biocompatibility Testing to ISO 10993-1 and ASTM F756
Packaging integrity & shelf life	Packaging/Shelf Life testing to ASTM D4169-16, ASTM F1980-16, ASTM 2096-11, ASTM F88-15
Sterilization effectiveness	Sterilization Validation to ISO 11135
Labeling compliance	Labeling to ISO 15223-1

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

This information is not provided because the "testing" is primarily engineering and bench testing, not a clinical study on patient data. There isn't a "test set" of patient data in the typical sense.

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. Ground truth as defined for clinical studies (e.g., expert consensus for diagnostic accuracy) is not part of this 510(k) submission, which focuses on device safety and performance equivalence through engineering and biocompatibility testing.

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

Not applicable. There is no clinical test set requiring adjudication in this context.

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 is not an AI device, and no MRMC study was conducted or referenced. The device is a cortical electrode, a physical medical instrument.

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

Not applicable. This is not an algorithm or AI device. The testing described focuses on the physical and electrical characteristics of the electrode.

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

The "ground truth" for this device's evaluation is primarily based on:

Engineering specifications and standards: Conformance to pre-defined physical dimensions, electrical properties (IEC 60601), and material properties.
Biocompatibility standards: Conformance to ISO 10993-1 and ASTM F756.
Predicate device characteristics: The NeuroOne Cortical Electrode is deemed substantially equivalent if its performance aligns with that of the legally marketed predicate device (PMT Subdural Cortical Electrode) in terms of intended use, indications for use, technological characteristics, and safety profile, such that any differences do not raise new questions of safety or efficacy.

8. The sample size for the training set:

Not applicable. There is no "training set" in the context of an AI/machine learning model for this physical medical device.

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

Not applicable. As there is no training set, there is no establishment of ground truth for one.

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 and Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

NeuroOne, Inc. % Debra Kridner President, Debra J Kridner LLC, Regulatory Consultant Debra J Kridner 10901 Red Circle Dr., Suite 150 Minnetonka. Minnesota 55343

Re: K192764

Trade/Device Name: NeuroOne Cortical Electrode Regulation Number: 21 CFR 882.1310 Regulation Name: Cortical Electrode Regulatory Class: Class II Product Code: GYC Dated: September 28, 2019 Received: September 30, 2019

Dear Debra Kridner:

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 Actinclude 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

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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 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-devices/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device (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,

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) K192764

Device Name

NeuroOne Cortical Electrode

Indications for Use (Describe)

The NeuroOne Cortical Electrodes are intended for temporary (less than 30 days) use with recording, and stimulation equipment for the recording, and stimulation of electrical signals on the surface of the brain.

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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Image /page/3/Picture/1 description: The image shows the word "Neuroone" in a stylized font. The "Neuro" part of the word is in gray, while the "one" part is in blue. There is a circular graphic between the two words that is divided into four sections, colored red, light pink, light blue, and dark blue. The logo appears to be for a company or organization called Neuroone.

510(k) Summary

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

510(k) Number:
Date Prepared:	September 28, 2019
Applicant:	NeuroOne, Inc.10901 Red Circle Dr., Suite 150Minnetonka, MN 55343Email: info@NeuroOneinc.comWebsite: www.NeuroOneinc.com
Contact Person:	Debra KridnerPresident, Debra J Kridner Consulting, LLC10901 Red Circle Dr., Suite 150Minnetonka, MN 55343Email: info@NeuroOneinc.com
SUBJECT DEVICE
Trade Name:	NeuroOne Cortical Electrode

Common Name:	Cortical Electrode
Classification Name:	Cortical electrode (21 CFR§882.1310)
Device Class:	Class 2
Product Code	GYC

DEVICE DESCRIPTION (For the Device Subject to This 510(k) Notification)

There are Similarities and Differences between the subject and predicate devices. The NeuroOne and PMT electrodes have the identical indications for use and intended use. The devices both have platinum contacts (PMT also has platinum/iridium contacts as an option). Both devices have the identical principles of operation. PMT uses silicone and NeuroOne uses polyimide film both are biocompatible for their intended use. Overall the configurations, dimensions/surface area of the electrodes are similar: with the NeuroOne electrode having a slightly smaller footprint. The NeuroOne device has undergone electrical, bench, and biocompatibility testing to demonstrate the differences in material and size of the contacts/electrodes do not raise questions of safety or efficacy.

INDICATIONS FOR USE (For the Device Subject to This 510(k) Notification)

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INDICATIONS FOR USE AND DEVICE CLASSIFICATION COMPARISON

The following tables provide a side-by-side comparison of the Cortical Electrode to the predicate device to support this pre-market notification.

Intended Use/Indications for Use Comparison
	Subject Device	Predicate DeviceK082474
Intended Use	A cortical electrode is an electrode which istemporarily placed on the surface of the brainfor stimulating the brain or recording thebrain's electrical activity.	A cortical electrode is an electrode which istemporarily placed on the surface of the brainfor stimulating the brain or recording thebrain's electrical activity.
Indications forUse	The NeuroOne Cortical Electrodes	Catalog Numbers 21 10-XXX: The SubduralCortical Electrodes (Dual Side MacroElectrodes, Dual Side Micro Electrodes,Dual Side Macro-Micro Electrodes, DualSided Hemispherical Macro Electrodes,Dual Sided Hemispherical Micro Electrodes,Dual Side Hemispherical Macro-MicroElectrodes, Macro Grids, Macro Strip,Macro-Micro Grids, Macro-Micro Strips,Micro Grids, and Micro Strips.)
	are intended for temporary (less than 30 days)use with recording, monitoring, andstimulation equipment for the recording,monitoring, and stimulation of electricalsignals on the surface of the brain.	are intended for temporary (<30 day)use with recording, monitoring, andstimulation equipment for the recording,monitoring and stimulation of electricalsignals on the surface of the brain.

Device Classification Comparison Subject Device
	Subject Device	Predicate DeviceK082474
Trade/Device Name:	NeuroOne Cortical Electrode	PMT Subdural Cortical Electrode
Common Name:	Cortical electrode	Cortical electrode
Classification Number:	21 CFR 882.1310	21 CFR 882.1310
Classification Name:	Cortical electrode	Cortical electrode
Device Class:	Class 2	Class 2
Product Code:	GYC	GYC

Technological and Performance Characteristics Comparison
	Subject Device	Predicate Device
Manufacturer	NeuroOne, Inc.	PMT
Number of Contacts per Electrode	2 - 16	2 - 64
Thickness of Contact	0.0127 mm	0.5 - 1.01mm
Contact Diameter	3 mm	2 - 4.5mm
Contact Material(s)	Platinum	Platinum or stainless steel
Surface Area of Electrode	1x2 469mm²	1x2 570mm²
Electrode Film Material	Polyimide	Silicone
Electrode Film Thickness	0.0127 mm	0.5 - 1.01 mm
Thickness of Tail	0.0127 mm	1.40mm

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Technological and Performance Characteristics Comparison
	Subject Device	Predicate Device
Single patient use, Disposable	Yes	Same
Provided Sterile	Yes	Yes
Environment of Use	Intraoperative and Neurologicalmonitoring locations on surface ofbrain	Same
Duration of Use	Less than 30 days	Same
Principles of Operation	Cortical electrodes are placed onthe surface of the brain to record,monitor and stimulate brainactivity	Same

SUMMARY OF TESTING and PERFORMANCE STANDARDS

Performance testing was conducted to evaluate and characterize the performance of the device to support a determination of substantial equivalence to the predicate device. A comparison was made against the predicate where data was available. The NeuroOne device has undergone electrical, bench, and biocompatibility testing to demonstrate any differences do not raise questions of safety or efficacy.

. Design Verification Testing
- o Dimensional Measurements
  - O Durability
  - Mapping/Stimulation O
  - Reliability o
- Electrical to IEC 60601 O
Biocompatibility Testing to ISO 10993-1 and ASTM F756
. Packaging/Shelf Life to ASTM D4169-16, ASTM F1980-16, ASTM 2096-11, ASTM F88-15
Sterilization Validation to ISO 11135 ●
Labeling to ISO 15223-1 .

The Indications for Use, Intended Use, Fundamental Scientific Technology and Principles of Operation for the Cortical Electrode are the same as those described for the predicate device. The Cortical Electrode is found to have a safety and effectiveness profile that is the same as the predicate device and is determined by NeuroOne to be substantially equivalent.

In summary, the Cortical Electrode has the following similarities to the predicate device which has previously received 510(k) clearance:

Has the same indications for use
Has the same intended use

Used in the same anatomical site
- Uses the same technological characteristics

● Uses the same principles of operation

Uses the same sterilization methodology
Biocompatible for its intended use
SUBSTANTIAL EQUIVALENCE CONCLUSIONS

Through the comparison of technological and performance characteristics, the subject device is determined to be substantially equivalent to the predicate device.

Regulation Number and Section

§ 882.1310 Cortical electrode.

(a)
Identification. A cortical electrode is an electrode which is temporarily placed on the surface of the brain for stimulating the brain or recording the brain's electrical activity.(b)
Classification. Class II (performance standards).