This device is indicated for use in surgical procedures for patient-connected intraoperative nerve monitoring, i.e. assisting the surgeon in locating and mapping motor nerves through the use of electromyographic (EMG) signals and electrical stimulus of nerves.

Device Description

NIM PRS is a multi-channel intraoperative neurophysiological monitor capable of connecting various styles of patient monitoring electrodes and supplying electrical stimulus for evoked responses. The monitoring console uses both video and audio output to alert the user of EMG responses during a surgical procedure. EMG responses monitored with the device may originate from operator applied electrical stimulus or from direct mechanical stimulus occurring during the course of the surgery. Acquired data may be stored on various types of durable media, and hard copy may be obtained via an optional printer.

AI/ML Overview

The provided text is a 510(k) summary for the Medtronic Xomed NIM PRS device, which is an intraoperative neurophysiological monitor. This type of regulatory document is typically focused on demonstrating substantial equivalence to a predicate device, rather than presenting a detailed study proving performance against specific acceptance criteria for a new, complex algorithm or AI model.

Therefore, many of the requested items (e.g., sample sizes for test/training sets, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth establishment) are not applicable to this type of submission as they relate to analytical or clinical validation studies for novel algorithms, which are not described here.

The document primarily focuses on comparing the new device (NIM PRS) to a predicate device (NIM-4) to show substantial equivalence, especially in terms of features and intended use.

Here's a breakdown of the information that can be extracted or inferred from the provided text, and where the information is not present:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria here are implicitly showing substantial equivalence to the predicate device, NIM-4 (K982595), which is already legally marketed. The "performance" is described as having similar features and functionality.

Characteristic	Acceptance Criteria (Predicate Device K982595 Performance)	Reported Device (NIM-PRS) Performance
Multi-channel intraoperative neurophysiological monitor	Yes (4 channels)	Yes (8 channels) - Exceeds predicate channel count
Indicated for use in surgical procedures for patient-connected intraoperative nerve monitoring, i.e. assisting the surgeon in locating and mapping motor nerves through the use of electromyographic (EMG) signals and electrical stimulus of nerves	Yes	Yes
Complies with IEC 60601-1 electrical safety standards	Yes	Yes
Capable of connecting various styles of patient monitoring electrodes	Yes	Yes
Capable of supplying electrical stimulus for evoked responses	Yes (1 stimulator 0 - 3 mA)	Yes (2 stimulators 0 - 30 mA and 0 - 120 mA) - Exceeds predicate stimulus range/quantity
Capable of connecting various styles of patient stimulating electrodes	Yes	Yes
Uses both video and audio output to alert the user of EMG responses during a surgical procedure	Yes	Yes
Monitors EMG responses originating from operator applied electrical stimulus	Yes	Yes
Monitors EMG responses originating from direct or indirect mechanical stimulus	Yes	Yes
Acquired data may be printed on hard copy via an optional printer	Yes	Yes (May also be stored on various types of durable media) - Enhanced capability

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

Sample Size: Not applicable. This submission relies on substantial equivalence to a predicate device, not on a new clinical performance study with a test set of patient data.
Data Provenance: Not applicable.

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

Number of Experts: Not applicable. No test set requiring expert ground truth is described.
Qualifications: Not applicable.

4. Adjudication method for the test set

Adjudication method: Not applicable. No test set requiring adjudication is 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

MRMC Study: No. This device is an intraoperative nerve monitor, not an AI-assisted diagnostic imaging or interpretation tool that would typically undergo an MRMC study.
Effect Size: Not applicable.

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

Standalone Performance: Not applicable. This device is a monitoring system intended for human-in-the-loop use during surgery, not a standalone AI algorithm generating interpretations.

7. The type of ground truth used

Type of Ground Truth: Not applicable. The submission is based on demonstrating functional equivalence to an existing device rather than a new diagnostic claim requiring external ground truth validation. The "ground truth" for this type of submission is the established safety and effectiveness of the predicate device.

8. The sample size for the training set

Sample Size: Not applicable. This device does not describe an AI/ML component that requires a training set in the conventional sense. Its "training" would be related to its engineering design and validation against electrical safety and performance standards.

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

How Ground Truth was Established: Not applicable.

Summary

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510(k) Summary

1.0 Date Prepared

January 2, 2003

2.0 Submitter (Contact)

Martin D. Sargent Regulatory Affairs Manager Medtronic Xomed Jacksonville, FL (904) 279-7586

3.0 Device Name

Proprietary Name:	NIM PRS (The tradename has not been finalized at this time)
Common Name(s):	Nerve Integrity Monitor, Intraoperative Electromyographic(EMG) Monitor, Nerve locator / stimulator
Classification Name(s):	Nerve locator / stimulator, Electromyographic (EMG) Monitor

Device Classification 4.0

Classification Name:
Procode	Class
77ETN	II	21 CFR § 874.1820
89IKN	II	21 CFR § 890.1375

5.0 Device Description

Indications for Use 6.0

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510(k) Summary (continued)

7.0 Substantial Equivalence

The basic instrumentation, design, technology, system features, functions, and the principle of operation of the NIM-PRS are substantially equivalent to the Medtronic Xomed NIM-4 (K982595).

Characteristic	NIM-4 (K982595)(Tradename NIM-Response)	NIM-PRS(Proposed device)
Multi-channel intraoperativeneurophysiological monitor	Yes(4 channels)	Yes(8 channels)
Indicated for use in surgicalprocedures for patient-connectedintraoperative nerve monitoring,i.e. assisting the surgeon inlocating and mapping motornerves through the use of elec-tromyographic (EMG) signals andelectrical stimulus of nerves	Yes	Yes
Complies with IEC 60601-1electrical safety standards	Yes	Yes
Capable of connecting variousstyles of patient monitoringelectrodes	Yes	Yes
Capable of supplying electricalstimulus for evoked responses	Yes(1 stimulator 0 - 3 mA)	Yes(2 stimulators 0 - 30 mA and0 - 120 mA)
Capable of connecting variousstyles of patient stimulatingelectrodes	Yes	Yes
Uses both video and audio outputto alert the user of EMG responsesduring a surgical procedure	Yes	Yes
Monitors EMG responses origi-nating from operator appliedelectrical stimulus	Yes	Yes
Monitors EMG responses origi-nating from direct or indirectmechanical stimulus	Yes	Yes
Acquired data may be printed onhard copy via an optional printer	Yes	Yes(May also be stored on varioustypes of durable media)

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the symbol. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 0 6 2003

Medtronic Xomed c/o Robert Mosenkis CITECH 5200 Butler Pike Plymouth Meeting, PA 19462-1298

Re: K024316

Trade/Device Name: NIM-PRS Regulation Number: 21 CFR 874.1820; 21CFR890.1375 Regulation Name: Stimulator, Nerve; Electromyograph, Diagnostic Regulatory Class: Class II Product Code: ETN; IKN Dated: December 24, 2002 Received: December 26, 2002

Dear Mr. Mosenkis:

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

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Page 2 - Robert Mosenkis

forth in 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. 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 (301) 594-4692. 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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510(k) Number (if known): < O 2 4 3 16 NIM PRS Device Name: Indications for Use:

This device is indicated for use in surgical procedures for patient-connected intraoperative nerve monitoring, i.e. assisting the surgeon in locating and mapping motor nerves through the use of electromyographic (EMG) signals and electrical stimulus of nerves.

(Please do not write below this line - continue on another page if needed) Concurrence of CDRH, Office of Device Evaluation (ODE)

Euch. Thum, m.

510(k) Number K024316

Prescription Use (Per 21 CFR 801.109)

Over-the-Counter Use __

(Optional Format 1-2-96)

Regulation Number and Section

§ 890.1375 Diagnostic electromyograph.

(a)
Identification. A diagnostic electromyograph is a device intended for medical purposes, such as to monitor and display the bioelectric signals produced by muscles, to stimulate peripheral nerves, and to monitor and display the electrical activity produced by nerves, for the diagnosis and prognosis of neuromuscular disease.(b)
Classification. Class II (performance standards).