The Nicolet Electrocautery Detector is an accessory device supporting muting of external audible outputs when electrocautery interference is detected.

Device Description

The Nicolet Electrocautery Detector interfaces between the auditory signal output from a nerve monitor and the nerve monitor's external speaker. The Electrocautery Detector automatically mutes the nerve monitor speaker when electrocautery interference is detected.

AI/ML Overview

The Nicolet Electrocautery Detector is an accessory device designed to mute external audible outputs from a nerve monitor when electrocautery interference is detected. The device's performance is compared to a predicate device, the XOMED NIM-2 XL.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Feature	Acceptance Criteria (Predicate Device: XOMED NIM-2 XL)	Reported Device Performance (Nicolet Electrocautery Detector)
Indication for Use	As a feature of nerve monitoring, an electrocautery detection and muting feature is provided.	Accessory device supporting muting of external audible outputs when electrocautery interference is detected.
Environment of Use	Hospitals and clinics	Wherever nerve monitors and stimulators are used. Typically hospitals and clinics.
Number of electrocautery detector inputs	4	2
Technology	Detection of electrocautery Radio Frequency energy and muting of audible output.	Detection of electrocautery Radio Frequency energy and muting of audible output.
Recovery Time After Mute	≤ 5 seconds	≤ 1 second
Electrocautery Detector Sensitivity Adjustment	Yes - User Selectable	Yes - User selectable
Adjustable Sensitivity to Electrocautery Interference Detection	Yes	Yes

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

The provided summary does not contain information regarding a specific "test set" in the context of clinical trials or performance testing with human subjects. The comparison is based on device specifications and features, not a study involving a particular sample size of cases or patients. The data provenance is derived from the technical specifications and design of the Nicolet Electrocautery Detector and its predicate device. This is a comparison of product specifications, not a clinical study.

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

Since there is no mention of a "test set" for a clinical study or performance evaluation with human data, there is no information on the number of experts or their qualifications used to establish ground truth.

4. Adjudication Method for the Test Set

As there is no mention of a "test set" involving expert review of cases, there is no information on an adjudication method.

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

The document does not describe an MRMC comparative effectiveness study. This device is an accessory for a nerve monitor, designed to automatically mute auditory signals, not an AI-based diagnostic tool requiring human reader interpretation or improvement. Therefore, there is no information on an effect size for human reader improvement with or without AI assistance.

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

The document does not describe a standalone algorithm performance study. The device functions as an accessory that performs an automated action (muting) based on detecting electrocautery interference. The "performance" is implicitly evaluated by comparing its technical specifications (like recovery time and detection method) to those of the predicate device.

7. The Type of Ground Truth Used

The "ground truth" in this context is the technical specifications and functional design of the device and its predicate. The assessment is made by comparing these attributes, particularly the method of electrocautery detection and muting, and key performance parameters like recovery time. There is no mention of ground truth established by expert consensus, pathology, or outcomes data in a clinical trial setting.

8. The Sample Size for the Training Set

The provided document does not mention a "training set". This type of device, an electro-mechanical accessory, is not typically developed using machine learning or AI models that require a training set of data. Its functionality is based on detecting physical RF energy.

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

Since there is no mention of a training set, there is no information on how ground truth for a training set was established.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for Nicolet Biomedical. The word "Nicolet" is in large, bold, sans-serif font. A thick black line is underneath the word "Nicolet". Below the line, the word "BIOMEDICAL" is in a smaller, sans-serif font, with a space between each letter.

K020955

APR 1 7 2002

Summary of Safety and Effectiveness

Company Name:	Nicolet Biomedical5225 Verona RoadMadison, WI 53711
Contact:Phone:Fax:	Glen Hermanson, Manager of Standards and Compliance608 441-2065608 441-2007
Summary Date:	March 20, 2002
Trade Name:	Electrocautery Detector
Common Name:	Nerve Stimulator
Classification Name:	21 CFR 874.1820; Product Code: ETN
Predicate Device:	510(k) Number: K934426Manufacture: XOMED-TREACE, Inc.

Nerve Integrity Monitor-2 (NIM-2 XL) Trade Name:

Description of Device 1.0

2.0 Intended Use

The intended use of the Nicolet Electrocautery Detector is as an accessory device supporting muting of external audible outputs when electrocautery interference is detected.

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Image /page/1/Picture/0 description: The image shows the logo for Nicolet Biomedical. The word "Nicolet" is in a large, bold, sans-serif font. A thick black line is underneath the word "Nicolet". Below the line, the word "BIOMEDICAL" is in a smaller, sans-serif font, with a space between each letter.

Technological 3.0

The technology of the Electrocautery Detector is equivalent to the electrocautery mute feature in the predicate device. Both devices detect the presence of electrocautery RF energy as an interference signal and mute the speaker.

Conclusions 4.0

The intended use and technology of the Nicolet Electrocautery Detector device is substantially equivalent to the predicate device, electrocautery mute feature. No new questions of safety or effectiveness are raised.

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Specifications/Comparison to Predicates 5.0

Table 5.0-1 compares features and specifications of the Nicolet Electrocautery Detector to the predicate device

Feature	Nicolet Electrocautery Detector Device(Under Review)	XOMED NIM-2 XL(Predicate K934426)	Substantial Equivalence Comments
Indication for Use	The Nicolet Electrocautery Detector is anaccessory device supporting muting of externalaudible outputs when electrocautery interferenceis detected.	As a feature of nerve monitoring, anelectrocautery detection and muting feature isprovided.	Same features with regard to electrocauterydetection and muting of audible output.
Environment ofUse	Wherever nerve monitors and stimulators areused. Typically hospitals and clinics.	Hospitals and clinics	Used in the same clinical environments.
Number ofelectrocauterydetector inputs	2	4	Up to 2 electrocautery antenna probe inputs aresupported on the Electrocautery Detector.
Technology	Detection of electrocautery Radio Frequencyenergy and muting of audible output.	Detection of electrocautery Radio Frequencyenergy and muting of audible output.	Same
Recovery TimeAfter Mute	≤ 1 second	≤ 5 seconds	The Nicolet Electrocautery Detector has a fasterrecovery time from a muted condition.
ElectrocauteryDetectorSensitivityAdjustment	Yes - User selectable	Yes - User Selectable	Same
AdjustableSensitivity toElectrocauteryInterferenceDetection	Yes	Yes	Same

CONFIDENTIAL

Electrocautery Mute 510(k)

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Electrocautery Mute 510(k)

CONFIDENTIAL

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human form or a bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 7 2002

Nicolet Biomedical, Inc c/o Gary Syring, Principal Consultant Ouality and Regulatory Associates, LLC 800 Levanger Lane Stoughton, WI 53589

Re: K020955

Trade/Device Name: Nicolet Electrocautery Detector Regulation Number: 21 CFR 874.1820 Regulation Name: Surgical Nerve Stimulator/Locator Regulatory Class: Class II Product Code: ETN Dated: March 20, 2002 Received: March 25, 2002

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, Principal Consultant

This letter will allow you to begin marketing your device as described in your Section 510(k) r market notification. The FDA finding of substantial equivalence of your device to a legally promated 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 vours,

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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10209 510(k) Number (if known):

Device Name: Nicolet Electrocautery Detector

Indications For Use:

The Nicolet Electrocautery Detector is an accessory device supporting muting of external audible outputs when electrocautery interference is detected.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

(Optional Format 3-10-98)

Prescription Use yes ✓
(Per 21 CFR 801.109)

Vann Biller

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

02 510(k) Number.

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.