The FREMAP Cranial Nerve Electrodes are designed for intraoperative (=< 10 hours) monitoring/recording from and stimulation to the facial nerve or facial nerve root at the CP angle during skull based surgical procedures when comnected to the MEE-1000A or MEE-2000 Neural Function Measuring System.

Device Description

The device under review is a Facial nerve Root Evoked Muscle Action Potential (FREMAP) electrode. The electrode is used to elicit the muscle action potentials by electric stimulation directly to the facial nerve. It is commonly placed on the facial nerve or facial nerve root at the CP-angle and is used for monitoring (elicit) the muscle action potential response to preserve the facial nerve function especially during acoustic neuroma surgery or tumor removal (such as meningioma) at the CP-angle. The FREMAP electrodes are non-active and are intended to be connected to Nihon Kohden Corporation's Neural Function Measuring System Neuromaster MEE-1000A or MEE-2000

AI/ML Overview

The document provided is a 510(k) premarket notification for a medical device called the "FREMAP Cranial Nerve Electrode." It compares the device to several predicate devices to demonstrate substantial equivalence, rather than presenting a study where the device's performance is measured against acceptance criteria in a clinical or simulated clinical setting.

Therefore, the requested information regarding acceptance criteria, reported device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set details, and ground truth establishment cannot be fully provided from the given document.

However, I can extract the performance tests performed to demonstrate substantial equivalence, which serve as a form of acceptance criteria in the context of this 510(k) submission.

Here's a breakdown of what can be extracted and what cannot:

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

The document lists performance tests conducted to establish substantial equivalence. It states that "Test requirements were met or a process monitor is in place to confirm compliance." Specific quantitative results or typical acceptance ranges for these tests are not provided in the document.

Test	Summary of Requirement	Reported Device Performance
Electrical Resistance	Measure electrical resistance from the electrode contact to connector.	Met (or process monitor in place to confirm compliance)
FREMAP electrode Connector compatibility with monitor equipment	Verify the FREMAP electrode Connector is able to connect to neural function measuring systems (MEE-1000A or MEE-2000).	Met (or process monitor in place to confirm compliance)
Electrical continuity and resistance after tensile testing	Verify electrical continuity and resistance properties are met after tensile load was applied to the FREMAP electrode.	Met (or process monitor in place to confirm compliance)
Electrode separation under tensile test	Evaluate risk of electrode head separation with a load under tensile test.	Met (or process monitor in place to confirm compliance)
Electrical continuity and resistance after simulated use.	Apply a simulated stimulation potential for the 10 hour anticipated duration of intraoperative use.	Met (or process monitor in place to confirm compliance)
Overall length	Confirm dimensional requirements are met.	Met (or process monitor in place to confirm compliance)
Biocompatibility (Cytotoxicity, Sensitization, Intracutaneous Test and Acute System Toxicity)	Evaluations for these specific biological effects of manufactured and sterilized FREMAP Electrodes.	Performed and presumably met, though specific results not listed.

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

Sample Size: The document does not specify the sample sizes for any of the performance tests listed. This is not a clinical study but rather a series of engineering and biological safety tests.
Data Provenance: The document does not specify the country of origin of the data or whether the data is retrospective or prospective. These are lab tests performed by the manufacturer.

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

This information is not applicable as the document describes engineering and biocompatibility tests, not a study requiring expert-established ground truth for device performance in a diagnostic or clinical decision-making context.

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

This information is not applicable for the type of tests 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:

No, an MRMC comparative effectiveness study was not done. The FREMAP electrode is a passive cranial nerve electrode for monitoring and stimulation, not an AI-powered diagnostic or assistive device for human readers.

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

This information is not applicable. The device is a passive electrode, not an algorithm.

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

For the performance tests mentioned (electrical resistance, continuity, tensile strength, dimensions, biocompatibility), the "ground truth" would be the engineering specifications and established ISO/ASTM standards for medical device materials and components, and biological safety standards (e.g., ISO 10993 for biocompatibility). The document does not detail these specific standards or criteria, only that the tests were performed and requirements were met.

8. The sample size for the training set:

This is not applicable as the FREMAP electrode is not an AI/ML device that requires a training set.

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

This is not applicable as the FREMAP electrode is not an AI/ML device that requires a training set.

In summary: The provided document is a 510(k) submission focused on demonstrating substantial equivalence through a comparison of technological characteristics and safety/performance testing of the device itself (an electrode), rather than an efficacy study of a diagnostic or AI-powered system involving clinical data and human interpretation. Therefore, many of the requested elements are not relevant or present in this type of regulatory submission.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, stacked on top of each other.

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

May 6, 2016

Ad-tech Medical Instrument Corporation % Gary Syring Principal Consultant Quality & Regulatory Associates, LLC 800 Levanger Lane Stoughton, WI 53589

Re: K152769

Trade/Device Name: FREMAP Electrode Regulation Number: 21 CFR 882.1820 Regulation Name: Surgical Nerve Stimulator/Locator Regulatory Class: Class II Product Code: ETN, GZL, GYC Dated: April 7, 2016 Received: April 8, 2016

Dear Mr. Syring:

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.

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) 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 contact the Division of Industry and Consumer Education 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. 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

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 Industry and Consumer Education 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,

William J. Heetderks -A

Digitally signed by William J. Heetderks -A
ON: c=US, o=U.S. Government, ou=HHS, ou=NIH,
ou=People, 0.9.2342.19200300.100.1.1=0010149848,
n=William J. Heetderks -A
Date: 2016.05.06 08:44:04 -04'00'

for Carlos L. Peña, PhD, MS

Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K152769

Device Name

FREMAP Cranial nerve Electrode

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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IMENT CORPORATION

5.0 510(k) Summary

This summary is provided to support the 510(k) pre-market notification for the FREMAP Cranial Nerve Electrode.

Company Name:	Ad-Tech Medical Instrument Corporation1901 William StreetRacine, WI 53404Phone: (262) 634-1555
Company Contact:	Lisa Theama, Chief Operating Officer
Date Summary Prepared:	May 5, 2016
Trade Name:	FREMAP Cranial Nerve Electrode
Common Name:	Cortical Electrode
Classification Name(s):(Predicates andReference Devices)	21 CFR 874.1820 Surgical Nerve Stimulator/LocatorProduct Code: ETNClass II21 CFR 882.1330 Depth ElectrodeProduct Code: GZLClass II21 CFR 882.1310 Cortical ElectrodeProduct Code: GYCClass II
Predicate Devices:	K133348 IOM Stimulator Probes (Primary Predicate)K944061 Cueva Cranial Nerve Electrode

Reference Device: K053363 Subdural Electrode

Product Description 5.1

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The FREMAP electrodes are non-active and are intended to be connected to Nihon Kohden Corporation's Neural Function Measuring System Neuromaster MEE-1000A or MEE-2000

5.2 Intended Use of the Device

The intended use of the FREMAP electrode is the same as predicate devices:

The FREMAP Cranial Nerve Electrodes are designed for intraoperative (≤ 10 hours) monitoring/recording from and stimulation to the facial nerve or facial nerve root at the CP angle during skull based surgical procedures when connected to the MEE-1000A or MEE-2000 Neural Function Measuring System.

5.3 Summary of Technological Characteristics

The following table provides a side-by-side comparison the FREMAP electrode to the predicate devices applied to support this pre-market notification.

Feature	FREMAP Electrode(Under Review)	Cueva Electrode(Predicate K944061)	IOM StimulatorProbes(Primary PredicateK133348)	FREMAP ElectrodeEquivalenceDiscussion
Intended Use	The FREMAP cranialnerve electrodes areintended for nervemonitoring/recordingand stimulationduring acousticneuroma surgery ortumor removal at theCP-angle.	The Cueva CranialNerve Electrode isintended for use tomonitor cranial nervesduring skull base typesurgeries.	IOM StimulatorProbes are used bythe surgeon as themedium to deliverelectricalstimulation to tissueduringintra-operativeneurologicalmonitoring, toidentify nerves andspinal nerve rootsand to assess nervefunction.	The FREMAP cranialnerve electrodescombine the intendeduse of monitoringcranial nerves and anerve contactingstimulation electrode(probe) for cranialnerves (facial nerveand facial nerve root).
Indications forUse	The FREMAPCranial NerveElectrodes aredesigned forintraoperative (< 10hours)monitoring/recordingfrom the facial nerveor facial nerve root atthe CP angle duringskull based surgicalprocedures whenconnected to theMEE-1000A orMEE-2000 NeuralFunction MeasuringSystem.	The 510(k) submissionreferences use on theCochlear cranial nerve,Facial nerve,Glossopharyngeal nerve,Hypoglossal nerve,Spinal accessory nerveand Vagus nerve.	IOMStimulator Probesdisposable surgicalstimulators areindicated for tissuedissection andstimulation ofcranial andperipheral nerves forlocation andidentification duringsurgery, includingspinal nerve roots.	The indication for useof the FREMAPelectrode is the sameas the predicatedevices with regard tointraoperative use formonitoring (recording)from the surface ofcranial nerves (thefacial nerve is one ofthe predicate Cuevanerves monitored) andapplication ofstimulation for anevoked response of thefacial nerve and facialnerve root (the IOMNeural StimulatorProbe InsulatedMonopolar is applied
Feature	FREMAP Electrode(Under Review)	Cueva Electrode(Predicate K944061)	IOM StimulatorProbes(Primary PredicateK133348)	FREMAP ElectrodeEquivalenceDiscussion
				for stimulation ofcranial nerves.) Thefacial nerve and facialnerve root are cranialnerves.
Contraindications	The FREMAP cranialnerve electrodesshould not be used onany patient who thephysician/surgeonconsiders at risk forinfection or for whomthe surgical recordingand stimulationprocedure cannot beperformed safely andeffectively.This device is notintended for use inMRI procedures.	The Cueva Electrode shouldnot be used on any patient whothe physician/surgeon considersat risk for infection.	Unknown	Same with regard tothe risk for infectionfrom the predicateCueva Electrode.
Clinical Use	The FREMAPelectrode recordscranial (facial nerveand facial nerve root)action potentials andmay be used forstimulation of thesenerves.	Cueva Cranial Nerveelectrodes provide directcranial nerve monitoringduring skull basedsurgeries.	IOM StimulatorProbes providedirect cranial nervestimulation(monitoring) duringintraoperative skullbased surgeries.	All electrodes (probes)are applied to thesurface of the nerve tosupport nerverecording andstimulation within theskull duringintraoperativeprocedures.
FundamentalTechnicalFunction	Monopolar electrodecontact placed on thesurface of the nerveby the user, insupport of monitoringand stimulating thenerve.	Monopolar electrodecontact placed on thesurface of the nerve bythe user, in support ofmonitoring nervefunction.	Monopolar electrodecontact placed onthe surface of thenerve by the user, insupport ofstimulation of thenerve.	The fundamentaltechnical function ofthe FREMAPelectrode and thepredicate Cuevaelectrode, IOMStimulator Probe is thesame.
Single PatientUse, Disposable	Yes	Yes	Yes	Same
Provided Sterile	Yes	Yes	Yes	Same
Environment ofUse	Intraoperative	Intraoperative	Intraoperative	Same intraoperativeuse
Duration of Use	< 10 hours	< 10 hours	Intraoperative(Assumed to be < 10hours)	Same intraoperativeduration of use.
Number ofElectrodeContacts	One (1)	One (1)	One (1)	Monopolar, oneelectrode contact.
ElectrodeMaterial	Platinum/Iridium	Platinum/Iridium	Stainless steel	Same as Cuevaelectrode forrecording. A reference
Feature	FREMAP Electrode(Under Review)	Cueva Electrode(Predicate K944061)	IOM StimulatorProbes(Primary PredicateK133348)	FREMAP ElectrodeEquivalenceDiscussion
				device withPlatinum/Iridium asthe nerve stimulatingelectrode contact isdiscussed.

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Features of the FREMAP electrode compared to the Predicate and Reference device are addressed below.

FREMAP Electrode Discussion
Feature	FREMAPElectrode(Under Review)	Cueva Electrode(Predicate K944061)IOM Stimulator Probes(Primary Predicate K133348)	SubduralElectrode(Reference DeviceK05336)	Safety and EffectivenessDiscussion
FundamentalTechnicalFunction	The FREMAPElectrode has amonopolarelectrode diskcontact.The monopolarelectrode contactis placed on thesurface of thenerve by the user.in support ofrecording fromand stimulating tothe nerve.	The Cueva electrode has amonopolar electrode contact ona C-shaped radius.The IOM stimulator probe(Neural Stimulator ProbeInsulated Monopolar) electrodehas a monopolar electrodecontact as a sphere.For both predicates, themonopolar electrode contact isplaced on the surface of thenerve by the user, in support ofrecording from and stimulatingto the nerve.	The referencesubdural electrodesare a circular disc.The electrodecontacts are placedon the surface ofthe nerve (brain)by the user, insupport ofrecording from andstimulation to thenerve.	The FREMAP electrode isequivalent to the circulardisk of the referenceSubdural Electrode.The Subdural electrodesare indicated for recordingfrom and stimulation to acranial nerve, the brain.
ElectrodeMaterial	Platinum/Iridium	Cueva: Platinum/Iridium(Recording)IOM Probe: Stainless Steel(Stimulation)	Platinum/Iridium(Recording andStimulation)orStainless Steel(Recording andStimulation)	The reference Subduralelectrode applies the samePlatinum/Iridium as thestimulating electrodecontact material to nervetissue.

Performance Tests to Demonstrate Substantial Equivalency 5.4

To establish the technical equivalency of the FREMAP electrode, evaluations were conducted to evaluate compliance with performance requirements, including:

Test	Summary of Requirement
Electrical Resistance	Measure electrical resistance from the electrode contact to connector.
FREMAP electrode Connectorcompatibility with monitor	Verify the FREMAP electrode Connector is able to connect to neuralfunction measuring systems.

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Test	Summary of Requirement
equipment
Electrical continuity andresistance after tensile testing	Verify electrical continuity and resistance properties are met aftertensile load was applied to the FREMAP electrode.
Electrode separation undertensile test	Evaluate risk of electrode head separation with a load under tensiletest.
Electrical continuity andresistance after simulated use.	Apply a simulated stimulation potential for the 10 hour anticipatedduration of intraoperative use.
Overall length	Confirm dimensional requirements are met.

Test requirements were met or a process monitor is in place to confirm compliance.

Biocompatibility evaluations of manufactured and sterilized FREMAP Electrodes were performed for Cytotoxicity, Sensitization, Intracutaneous Test and Acute System Toxicity.

5.5 Conclusion

The FREMAP electrode meets performance requirements. The intended use and technology of the FREMAP electrode are the same as the predicate devices.

Regulation Number and Section

§ 874.1820 Surgical nerve stimulator/locator.

(a)
Identification. A surgical nerve stimulator/locator is a device that is intended to provide electrical stimulation to the body to locate and identify nerves and to test their excitability.(b)
Classification. Class II.