The Gyrus ENT Nerve Stimulator is intended to provide electrical stimulation to cranial and peripheral motor nerves to aid in nerve location during surgical procedures.

Device Description

The Gyrus ENT Nerve Stimulator that is described in this notification has the same technological characteristics, power modality and mode of operation as the predicate device.

AI/ML Overview

This 510(k) summary describes a traditional medical device, the Gyrus ENT Nerve Stimulator, not an AI/ML-powered device. Therefore, the specific questions regarding AI/ML study design, such as acceptance criteria based on AI performance metrics, sample sizes for AI training/test sets, expert adjudication for ground truth, MRMC studies, or standalone algorithm performance, are not applicable.

The submission focuses on demonstrating substantial equivalence to a predicate device (Neurosign Model 100) based on intended use and technological characteristics, as well as adherence to established safety standards.

Here's a breakdown of the requested information based on the provided text, adapted for a non-AI/ML device:

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

The acceptance criteria for the Gyrus ENT Nerve Stimulator appear to be compliance with specific electrical safety and electromagnetic compatibility (EMC) standards. The "reported device performance" is its successful testing against these standards.

Acceptance Criteria (Standards Met)	Reported Device Performance
UL2601/IEC 601 safety testing for 100Vac, 50/60 Hz	Device is designed to meet these standards.
UL2601/IEC 601 safety testing for 120Vac, 50/60 Hz	Device is designed to meet these standards.
UL2601/IEC 601 safety testing for 220Vac, 50/60 Hz	Device is designed to meet these standards.
UL2601/IEC 601 safety testing for 240Vac, 50/60 Hz	Device is designed to meet these standards.
EMC Testing, IEC 601-1-2	Device is designed to meet these standards.

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

Not applicable to this type of device submission. This is a traditional electrical medical device, and its performance is evaluated against engineering and safety standards, not through a clinical test set of patient data.

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 typically defined for AI/ML models (e.g., expert-labeled data) is not relevant here. The "ground truth" for this device's performance would be verifiable compliance with the specified safety and EMC standards, likely assessed by expert engineers and testing laboratories.

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

Not applicable. There is no "test set" in the context of patient data requiring adjudication for this type of device.

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-assisted device.

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

Not applicable. This is not an algorithm-only device.

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

The "ground truth" for this device's regulatory acceptance is its adherence to universally recognized and specified electrical safety (UL2601/IEC 601) and electromagnetic compatibility (IEC 601-1-2) standards. This is not a biological or clinical ground truth, but an engineering and regulatory one, confirmed through compliance testing.

8. The sample size for the training set

Not applicable. This device is not an AI/ML model that undergoes a training phase.

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

Not applicable.

Summary of the Study/Evidence Provided:

The provided documents describe a 510(k) submission for the Gyrus ENT Nerve Stimulator. The "study" mentioned is not a clinical trial in the typical sense for AI/ML devices, but rather a demonstration of substantial equivalence to an existing predicate device (Neurosign Model 100) and adherence to established safety and EMC standards.

Substantial Equivalence: The submission asserts that the Gyrus ENT Nerve Stimulator has the same intended use and similar technological characteristics (e.g., power supply, current range, probe support) as the predicate device, the Neurosign Model 100. Differences in frequency settings and current display are noted but considered not to raise new issues of safety or effectiveness.
Safety and Performance Testing (Implicit): The device is stated to be "designed to meet" UL2601/IEC 601 for various AC voltages and IEC 601-1-2 for EMC. This implies that testing was conducted or design validated to ensure compliance with these international electrical safety and electromagnetic compatibility standards. The compliance with these standards serves as the performance demonstration for the safety aspects of the device.

In conclusion, for this traditional nerve stimulator, the "acceptance criteria" revolve around established regulatory pathways for medical devices: demonstrating substantial equivalence to a predicate and compliance with recognized safety and performance standards, rather than clinical performance metrics in a study with patient data.

Summary

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OCT 2 4 2002

510(k) Summary of Safety and Effectiveness

Trade Name:	Gyrus ENT Nerve Stimulator
Common Name:	Surgical nerve stimulator/locator
Classification Name:	Surgical nerve stimulator/locator (§ 874.1820)
Official Contact:	Gregory SredinSr. Regulatory Affairs SpecialistGyrus ENT LLC2925 Appling RoadBartlett, TN 38133
Telephone:	(901) 373-0200
Telefax:	(901) 387-3914
Date Prepared:	May 13, 2002

The Gyrus ENT Nerve Stimulator is intended to provide electrical stimulation to cranial and peripheral motor nerves to aid in nerve location during surgical procedures.

The Gyrus ENT Nerve Stimulator that is described in this notification has the same technological characteristics, power modality and mode of operation as the predicate device. The intended use is substantially equivalent to the described predicate Neurosign Model 100. The Gyrus ENT Nerve Stimulator is designed to meet:

UL2601/IEC 601 safety testing for 100Vac, 50/60 Hz. .
UL2601/IEC 601 safety testing for 120Vac, 50/60 Hz. .
UL2601/IEC 601 safety testing for 220Vac, 50/60 Hz. .
UL2601/IEC 601 safety testing for 240Vac, 50/60 Hz. .
EMC Testing, IEC 601-1-2. .

Conclusion: As a nerve stimulator only the Gyrus ENT Nerve Stimulator has the same intended use and the same basic technological characteristics as the Neurosion Model 100 Neural Tissue Stimulator and does not raise any new issues of safety or effectiveness.

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	Gyrus ENT Nerve Monitor	Neurosign 100 Nerve Monitor
Intended Use	The Gyrus ENT Nerve Stimulator is intendedto provide electrical stimulation to the body tolocate and identify nerves and to test theirexcitability.	The device is intended to stimulate and monitorcranial motor nerves.
Power Supply	100-240VAC; 50-60Hz, features poweron LED.	100-240VAC; 50-60Hz
Frequency	3, 10, 30Hz, touch pad and frequencyconfirm indicator.	3, 30Hz, 2-position switch, nofrequency confirm indicator.
Current	0.1 - 5.0 ma, in 0.1 ma incrementswith display to show setting andcurrent confirm indicator.	0.15 - 5.0 ma, variable settings, but nodisplay to show actual setting. Doesfeature current confirm indicator,
Probes supported	Monopolar and Bipolar	Monopolar and Bipolar

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Gyrus ENT c/o Greg Sredin Sr. Regulatory Affairs Specialist 2925 Appling Road Bartlett, TN 38133

Re: K021595

Trade/Device Name: Gyrus ENT Nerve Stimulator Regulation Number: 21 CFR 874.1820 Regulation Name: Surgical Nerve Stimulator/locator Regulatory Class: Class II Product Code: ETN Dated: September 17, 2002 Received: September 18, 2002

Dear Mr. Sredin:

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.

OCT 24 2002

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Page 2 – Greg Sredin

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

A. Ralph Rosenthal

A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

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Food and Drug Administration 510(k) Notification - Gyrus ENT Nerve Stimulator May 13, 2002

510(k) Number: Device Name:

KO215-95

Gyrus ENT Nerve Stimulator

Indications for Use:

The Gyrus ENT Nerve Stimulator is intended to provide electrical stimulation to cranial and peripheral motor nerves to aid in nerve location during surgical procedures.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use . (Per 21 CFR 801.109)

(Optional Format 1-2-96)

Prescription Use(Per 21 CFR 801.109)	✓
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Over-the-Counter
(Optional Format 1-2-96)

(Division Sign-Off)Division of Onhthalmic Ear, Nose a: .. session

510(k) Number K021595

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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.