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

The purpose of this 510(k) is to notify the FDA of changes that are intended to be made to the currently marketed NIM-2XL Nerve Integrity Monitor. As previously mentioned, these changes serve to improve the NIM-2XL even further: to make the device more "user friendly" and simplify its use, provide a cleaner, higher quality signal, provide additional options for documentation (printer, disk drive, and video-out) and to lower the overall cost of the system through the use of state-of-the-art componentry. Other than the changes specifically described in this notification, the device remains the same as previously provided in K934426.

AI/ML Overview

Here's an analysis of the provided text regarding the NIM Monitor, focusing on acceptance criteria and study details.

Important Note: The provided document is a 510(k) summary for a premarket notification (K982595) for the NIM Monitor (Nerve Integrity Monitor). This type of document is primarily focused on demonstrating substantial equivalence to a previously cleared device, not typically on presenting full clinical study data for new acceptance criteria. Therefore, many of the requested details about specific acceptance criteria and detailed study performance will likely be absent or only broadly implied.

Acceptance Criteria and Device Performance

Based on the provided K982595 510(k) summary, the device is an updated version of a previously cleared device (NIM-2XL). The primary "acceptance criteria" here are demonstrating substantial equivalence to the predicate device and that the changes do not raise any new safety or effectiveness issues.

Criterion Category	Specific Criterion / Performance Target	Reported Device Performance (NIM4 vs. NIM-2XL)
Intended Use	Same as predicate device (NIM-2XL)	"The proposed NIM4 Nerve Integrity Monitor... has the same intended use..."
Basic Technological Characteristics	Same as predicate device (NIM-2XL)	"...and the same basic technological characteristics as the previously cleared device..."
Safety	No greater risks than predicate device (NIM-2XL)	"The Hazard Analysis... confirms that the proposed modifications present no greater risks than those associated with the current system."
Effectiveness	No new issues of effectiveness compared to predicate device (NIM-2XL)	"...does not raise any new issues of safety or effectiveness."
"User-Friendly"	More user-friendly, simplified use	"serve to improve the NIM-2XL even further: to make the device more 'user friendly' and simplify its use..."
Signal Quality	Cleaner, higher quality signal	"...provide a cleaner, higher quality signal..."
Documentation Options	Additional options (printer, disk drive, video-out)	"...provide additional options for documentation (printer, disk drive, and video-out)..."
Cost	Lower overall system cost	"...to lower the overall cost of the system through the use of state-of-the-art componentry."

Study Information & Ground Truth

The document does not describe a standalone clinical study with new acceptance criteria in the way one might expect for a novel device or a device with significantly altered intended use. Instead, it relies on demonstrating that the modifications made to an already cleared device do not introduce new risks or change the fundamental performance that was previously accepted.

Here's a breakdown of the requested study details:

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not Applicable / Not Provided. The document does not describe a clinical "test set" in the traditional sense of evaluating new diagnostic accuracy or treatment efficacy. The evaluation performed appears to be a design verification and validation of the changes against the predicate device, including a "Hazard Analysis" and "software validation." This is an internal engineering and risk assessment process, not a clinical study with patients.
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 / Not Provided. Ground truth for a clinical test set is not discussed because a clinical test set, as typically understood, was not used or reported here. The "ground truth" for the device's acceptable performance is implicitly the demonstrated safety and effectiveness of the predicate device, NIM-2XL.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable / Not Provided. Adjudication methods are typically for resolving discrepancies in clinical assessments, which is not relevant to the type of submission presented.
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. This device is an intraoperative nerve monitor, not an AI-assisted diagnostic tool for human readers. An MRMC study is completely irrelevant here.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a medical device that monitors physiological signals; it inherently operates "standalone" in generating its output (EMG signals, electrical stimulation). However, its intended use is "assisting the surgeon," meaning a human (the surgeon) is always "in the loop" for decision-making based on the device's output. The concept of "standalone performance" as typically applied to an AI algorithm making a diagnosis without human input is not relevant here. The device's "performance" is its ability to accurately detect and stimulate nerves and display EMG signals.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Implicitly, the established safety and effectiveness of the predicate device (NIM-2XL). For the changes themselves, the "ground truth" for the Hazard Analysis would be engineering standards, risk assessment methodologies, and potentially internal verification/validation testing and expert reviews (though not specified in clinical terms).
The sample size for the training set:
- Not Applicable / Not Provided. This is not an AI/machine learning device that requires a "training set."
How the ground truth for the training set was established:
- Not Applicable. As above, no training set is relevant for this device.

Summary of Approach in K982595:

This 510(k) submission is an example of a "special 510(k)" or "traditional 510(k) for modifications" where the focus is on demonstrating that changes to an existing cleared device do not alter its fundamental safety or effectiveness. The "study" here is primarily a design control process, including a Hazard Analysis and software validation, to confirm that the modifications maintain equivalence to the predicate device and introduce no new risks. It is not a clinical trial establishing new performance metrics.

Summary

{0}------------------------------------------------

K982595

510(k) Summary NIM Monitor

1.0 Date Prepared July 22, 1998
SEP - 4 1998
2.0 Submitter (Contact) David Timlin Xomed Surgical Products Jacksonville, FL (904) 279-7532

3.0 Device Name

Proprietary Name:

NIM4 (The product's trade name has not been finalized and may be changed at a later date.)

Nerve Integrity Monitor, Intraoperative Electromyographic (EMG) Common Name(s): Monitor. Nerve locator / stimulator

Nerve locator / stimulator, Electromyographic (EMG) Monitor Classification Name:

Device Classification 4.0

Nerve locator / stimulator Procode 77 ENT Class II ; 21 CFR 874.1820

Electromyographic (EMG) Monitor 21 CFR 874.4140 Procode 89 CAB Class II :

5.0 Device Description

6.0 Intended Use

{1}------------------------------------------------

7.0 Substantial Equivalence

The added features described in this notification do not present any significant differences when compared to the currently marketed NIM-2XL Nerve Integrity Monitor. They do not change the intended use of the device and only serve to compliment the current system operation. The Hazard Analysis, included with the software validation, confirms that the proposed modifications present no greater risks than those associated with the current system. If anything, it is expected that the majority of the changes will aid in lowering the risk through simplification of use and cleaner signals.

Conclusion: The proposed NIM4 Nerve Integrity Monitor that is described in this notification, has the same intended use and the same basic technological characteristics as the previously cleared device; and, does not raise any new issues of safety or effectiveness.

2 2 8

{2}------------------------------------------------

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

David Timlin Manager, Regulatory Affairs Xomed. Inc. 6743 Southpoint Drive, N. Jacksonville, Florida 32216-0980 Re:

K982595 NIM (Nerve Integrity Monitor) Dated: July 24, 1998 Received: July 27, 1998 Regulatory Class: II 21 CFR 874.1820/Procode: 77 ETN

Dear Mr. Timlin:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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, against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510%) premarket notification. The FDA finding of substantial oquivalence 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 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmaldsmam.html".

Sincerely yours,

Kilian Yi

Lillian Yin, Ph.D. Director, Division of Reproductive Abdominal, Ear, Nose and Throa and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

Image /page/2/Picture/14 description: The image shows a logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three heads, representing the department's mission to protect the health of all Americans. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The letters "SEP" are in the bottom right corner of the image.

{3}------------------------------------------------

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: _

Indications for Use:

(Please do not write below this line - continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Elvin L. Ingram
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT,
and Radiological Devices

510(k) Number K982595

Or Over-t

Prescription Use _ (Per 21 CFR 801.109) Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

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.