The Hilger Dual-Stim Nerve Stimulator is a self contained, battery powered device. There is an option to provide a line powered option in the future. Two modes of nerve stimulation are provided, a Clinical Mode and a Surgical Mode.

AI/ML Overview

The provided document describes the Hilger Dual-Stim Nerve Stimulator, a device used for electrical nerve stimulation during diagnostic and surgical procedures. The 510(k) summary focuses on demonstrating substantial equivalence to predicate devices rather than conducting a de novo clinical study with specific acceptance criteria based on performance metrics. Therefore, the requested information regarding acceptance criteria, study details, and expert involvement for ground truth cannot be fully provided in the format typically associated with AI/ML device evaluations.

However, based on the provided text, the device's "acceptance criteria" are implied through its compliance with safety standards and a design control process, and its equivalence to predicate devices in terms of intended use and technical characteristics.

Here’s a breakdown of the information that can be extracted, and where limitations exist:

1. Table of Acceptance Criteria and Reported Device Performance

Feature/Criterion	Acceptance Criteria (Implied)	Reported Device Performance
Safety and Effectiveness	Demonstrated through compliance with design control process and safety standards.	"The safety and effectiveness of the Hilger Dual-Stim Nerve Stimulator was demonstrated by testing in compliance with the Design Control process."
Intended Use Equivalence	Same as predicate devices.	"The intended use... of the Hilger Dual-Stim Nerve Stimulator is the same as the predicate devices."
Technological Equivalence	Equivalent to predicate devices.	"The technical characteristics of the Hilger Dual-Stim Nerve Stimulator are equivalent to those of the predicate devices."
Safety Standards Compliance	Meet specified international safety standards (EN/IEC 60601-1, -1-2, -2-10, -2-40).	The device "met" or was tested "in compliance with" these standards.
Software Verification & Validation	Successfully completed.	"Software verification and validation" was performed.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not applicable. This document describes a traditional 510(k) submission for a non-AI/ML device where a "test set" in the context of data evaluation (like for AI performance) is not relevant. The device underwent engineering testing (software V&V, safety standard compliance) rather than performance evaluation against a labeled dataset.
Data Provenance: Not applicable in the context of a dataset for AI evaluation. The "data" here refers to test results from design verification and validation activities.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

Number of Experts & Qualifications: Not applicable. Ground truth, in the context of expert consensus for labeling data, is not mentioned because this is not an AI/ML device submission. The "ground truth" for this device's performance relies on engineering specifications and compliance with safety standards as verified by qualified engineers and testers.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. There is no mention of an adjudication process for a "test set" as understood in AI/ML performance evaluation. The compliance was determined through internal design control processes and testing against engineering requirements and safety standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and Effect Size

MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating human reader performance with and without AI assistance, which is not applicable to this nerve stimulator device.

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

Standalone Performance: Not applicable. This device is an electrical nerve stimulator; it does not rely on an algorithm to interpret data or make diagnostic decisions in a standalone capacity. Its function is to provide electrical stimulation for human interpretation of nerve response.

7. The Type of Ground Truth Used

Type of Ground Truth: The "ground truth" in this context is based on engineering specifications, international safety standards (e.g., EN/IEC 60601 series), and the established performance of predicate devices. The device's electrical output parameters (current, pulse width, frequency) are measured and compared against these defined specifications and those of the predicates.

8. The Sample Size for the Training Set

Sample Size for Training Set: Not applicable. This is not an AI/ML device that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Ground Truth for Training Set: Not applicable. This is not an AI/ML device that requires a training set or ground truth for such a set.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The "study" referenced in the document is the internal design control process and associated testing, which included:

Software verification and validation: Ensuring the device's software functions as intended and meets specifications.
Declaration of safety standard compliance: Demonstrating that the device adheres to relevant international safety standards (EN/IEC 60601-1, EN/IEC 60601-1-2, EN/IEC 60601-2-10, EN/IEC 60601-2-40). This would involve electrical safety testing, EMC testing, and other relevant tests depending on the specific standard.

The conclusion states that these activities were sufficient to demonstrate the safety and effectiveness of the Hilger Dual-Stim Nerve Stimulator and to show its substantial equivalence to predicate devices, thus raising "No new questions of safety or effectiveness."

Summary

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5063567

First Ronkes CO

/ORTH SECOND STREET, STILLWATER, MN 55082 ■ 651-430-1200 ■ TOLL-FREE 800-321-6387 ■ TAX 651-4.9-9733 ■ WWW.WWWFD C CM

510(k) Summary

Company Name:	WR Medical Electronics CO.
Device Name:	Hilger Dual-Stim Nerve Stimulator
		JAN - 5 2007
510(k) Sponsor, Contact:	WR Medical Electronics CO.123 North 2nd StreetStillwater, MN 55082Jack Blais, PresidentPhone: (651) 430-1200Fax: (651) 439-9733
Summary Date:	November 21, 2006
Common Name:	Nerve Stimulator
Classification Name:	Nerve Stimulator 21 CFR 874.1820, Product Code: ETN, Class II
Predicate Device(s):	Preamendment - Hilger Facial Nerve StimulatorK895838 - Brackman EMG Monitoring SystemK021595 - Gyrus ENT Nerve Stimulator

1.0 Description of Device

The Hilger Dual-Stim Nerve Stimulator is a self contained, battery powered device. There is an option to provide a line powered option in the future.

Two modes of nerve stimulation are provided, a Clinical Mode and a Surgical Mode. Table 1.0-1 summarizes the differences in these stimulation modes.

Feature	Clinical Mode	Surgical Mode
Stimulation Current	Up to 10 mA	Up to 10 mA
Stimulation Pulse Width	0.0006 micro second	0.0002 micro second
Stimulation Frequency	6 Hz	5 Hz

File: Hilger Dual Stim 510k 11-21-2006 final

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1.1 Variations and Accessories

The only variations of the Hilger Dual-Stim Nerve Stimulator are a battery powered device and a future optional AC line operated device. The safety standards that these two variations meet are the same.

Accessories applied to the Hilger Dual-Stim Nerve Stimulator are probe configurations compatible with the two different stimulation modes:

1. Bipolar Clinical Probe
1. Remote Surgical Probe
Monopolar Disposable Probe 3.
1. Silverstein Adapter for Continuous Stimulation (SACS Kit)
1. Hilger Dual-Stim Adapter.

The Hilger Dual-Stim Nerve Stimulator is used in hospitals, operating rooms and clinical environments to support clinical evaluation of nerves. The Hilger Dual-Stim Nerve Stimulator provides the nerve stimulation; the user provides the interpretation of appropriate nerve response.

2.0 Intended use of Device

The intended use of the Hilger Dual-Stim Nerve Stimulator is:

The Hilger Dual-Stim Nerve Stimulator provides electrical stimulation to nerves during diagnostic and surgical procedures.

3.0 Technological Characteristics

The technical characteristics of the Hilger Dual-Stim Nerve Stimulator are equivalent to those of the predicate devices. The following table summarizes significant feature comparisons.

File: Hilger Dual Stim 510k 11-21-2006 final

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	Feature	Hilger Dual-StimNerve StimulatorUnder Review	PredicateHilger(Preamendment)	PredicateBrackman(K895838)	PredicateGyrus ENT NerveStimulator(K021595)
1.	Intended Use,Indications forUse	The Hilger Dual-StimNerve Stimulatorprovides electricalstimulation to nervesduring diagnostic andsurgical procedures.	The Hilger FacialNerve Stimulatorprovides electricalstimulation to nervesto aid in nerve locationduring diagnostic andsurgical procedures.	The Brackman EMGMonitor/Stimulator isused to stimulate andmonitor cranial nerves	The Gyrus ENT NerveStimulator is intendedto provide electricalstimulation to cranialand peripheral motornerves to aid in nervelocation duringsurgical procedures.
2.	Environmentof Use	Hospital, OperatingRoom, Clinic	Hospital, OperatingRoom, Clinic	Hospital, OperatingRoom, Clinic	Hospital, OperatingRoom, Clinic
3.	StimulationModes	TwoClinical ModeSurgical Mode	OneSame as Hilger Dual-Stim Clinical Mode	OneSame as Hilger Dual-Stim Surgical Mode	One
4.	StimulationProbes	Bipolar Clinical ProbeRemote Surgical ProbeMonopolar DisposableProbe	Bipolar StimulatorProbe	Bipolar StimulatorProbeMonopolar SurgicalStimulating ProbeNeedle and Hook WireElectrodes	Monopolar andBipolar
5.	StimulationCurrent	0 to 10 mA	0 to 10 mA	0.01 to 4 mA	0 to 5 mA
6.	StimulationPulse Width	Clinical Mode:0.0006 secondsSurgical Mode:0.0002 seconds	0.0006 seconds	0.002 seconds	Unknown
7.	StimulationFrequency	Clinical Mode: 6 HzSurgical Mode: 5 Hz	6 Hz	5 Hz	3, 10, 30 Hz
8.	Power	Battery 6 VDC(4 – "C" Cells)Option for AC Power	Battery 6 VDC(4 -- "C" Cells)	Battery(Lead Acid)Battery ChargerAccessory option	AC Power
9.	SafetyStandardsCompliance	EN/IEC 60601-1EN/IEC 60601-1-2EN/IEC 60601-2-10EN/IEC 60601-2-40	EN/IEC 60601-1EN/IEC 60601-1-2	EN/IEC 60601-1EN/IEC 60601-1-2	IEC 601-1IEC 601-1-2

4.0 Data Summary

Testing of the Hilger Dual-Stim Nerve Stimulator was performed in compliance with the WR Medical Electronics CO. design control process. Testing included:

1. Software verification and validation, and
1. Declaration of safety standard compliance prior to commercial distribution.

File: Hilger Dual Stim 510k 11-21-2006 final

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5.0 Conclusions

The safety and effectiveness of the Hilger Dual-Stim Nerve Stimulator was demonstrated by testing in compliance with the Design Control process. The intended use and technology of the Hilger Dual-Stim Nerve Stimulator is the same as the predicate devices. No new questions of safety or effectiveness are raised.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its wings. The eagle is positioned to the right of a circular text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

WR Medical Electronics Co. c/o Gary Syring Principal Consultant Quality & Regulatory Associates 800 Lavanger Lane Stoughton. WI 53589

JAN - 5 2007

Re: K063560

Trade/Device Name: Hilger Dual-Stim Nerve Stimulator Regulation Number: 21 CFR 874:1820 Regulation Name: Surgical Nerve Stimulator/Locator Regulatory Class: Class II Product Code: ETN Dated: November 21, 2006 Received: November 27, 2006

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.

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Page 2 - Gary Syring

This letter will allow you to begin marketing your device as described in your Section 510/k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

M.B. Egelmisi MD

Malvina B Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use 510(k) Number (if known): KOR3560

Device Name: Hilger Dual-Stim Nerve Stimulator

Indications for Use:

The Hilger Dual-Stim Nerve Stimulator provides electrical stimulation to nerves during diagnostic and surgical procedures.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

Karen H. Baker

(Division Sign-Off) Division of Ophthalmic Ear, Nose and Throat Devises

KOGSSLA 510(k) Number.

Prescription Use
(Per 21 CFR 801.109) X

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.