The INS-1 Intraoperative Nerve Surveillance System is intended to provide intraoperative electromyographic (EMG) surveillance to assist in the location and evaluation of spinal nerves during percutaneous surgery of the spine, by administration of low amperage electrical energy to tissues and nerves at the operative site, and EMG monitoring of muscle groups associated with those nerves. The INS-1 System is designed for use in conjunction with the NuVasive Guided Spinal Arthroscopy System to assist in gaining controlled percutaneous access to the spinal nerve root, foramina, intervertebral disc, and surrounding tissues of the spine via uniportal or biportal posterior or posterolateral approach, where anatomical restrictions safely permit.

Device Description

The subject INS-1 System is an electronic device which uses arthroscopic surgical instruments, electrodes, and probes to stimulate spinal nerves with electrical energy, and through the use of electromyography (EMG) electrodes. monitors the sensitivity, and assists in determining the location, of spinal nerves during percutaneous surgery of the spine. The device employs a "Status" routine to determine the baseline functional status of exiting spinal nerves in the area of the operative target, and directs low amperage current through the distal tip of the NuVasive Expanding Cannula as it penetrates tissue to the operative target. Through a series of EMG electrodes placed on the muscle groups associated with the spinal nerves at the operative level of the spine, the INS-1 System monitors EMG activity in these muscle groups and, when the Cannula tip draws sufficiently near to one such nerve that the electrical energy it emits is strong enough to depolarize the nerve and create an EMG response, alerts the surgeon that the Cannula tip is in proximity to that nerve. An additional feature of the INS-1 System is a hand-held electrical probe which can assist the surgeon in determining if a nerve lies directly in the path of the instrumentation, and may also be used to ascertain whether a transpedicular screw has violated the pedicle wall. The INS-1 System consists of a reusable Control Unit and PreAmp module, and an assortment of disposable and reusable conductive probe cables, electrodes, and electrode leads.

AI/ML Overview

The provided text is a 510(k) summary for the NuVasive INS-1 Intraoperative Nerve Surveillance System. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, it does not contain detailed information about acceptance criteria, specific device performance metrics, or the design of a study to prove these criteria were met, as described in your request.

The document states:

"Animal studies conducted in the porcine model have established that 1) the principle functions of the INS-1 System are effectively performed, such that spinal nerve status and location may be ascertained and monitored, and 2) that the data acquired by the subject device during simulated surgical use in the animal model correlate well with those acquired simultaneously by a predicate device." This is the extent of the performance data provided.
"Summary of Clinical Tests (Not applicable.)" This indicates that no clinical tests were performed or required for this 510(k) submission.

Therefore, I cannot populate the table or answer most of your detailed questions because the necessary information is not present in the provided text.

Here is what can be inferred or explicitly stated from the document based on your request, with the understanding that key details are missing:

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

Acceptance Criteria	Reported Device Performance
Not specified in document	1. Principle functions (spinal nerve status/location) effectively performed in porcine model. 2. Data acquired in porcine model correlates well with a predicate device.

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

Sample size for test set: Not specified beyond "the porcine model."
Data provenance: Porcine model (animal study, explicitly stated as "non-clinical"). Country of origin not specified. Prospective (implied, as the study was conducted to demonstrate performance).

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 specified. The document only mentions "animal studies."

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

Not specified.

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

No MRMC study was done. This device is an EMG monitor/stimulator and not an AI-assisted diagnostic tool that would typically involve human readers.

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

The device's performance demonstration appears to be standalone (algorithm/device only) in the porcine model, as there's no mention of human interpretation within the performance assessment. However, the device's intended use is to "assist in the location and evaluation of spinal nerves" by a surgeon (human-in-the-loop for clinical use).

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

The ground truth for the porcine model correlation study is implied to be actual spinal nerve response/location in the animal model, as well as comparison to a "predicate device" which served as a reference. The precise method of establishing what constituted an "effectively performed" function or "well correlated" data is not detailed.

8. The sample size for the training set

Not applicable/Not specified. This document only describes a performance evaluation (test set) and does not mention a training set, which is typically relevant for machine learning or AI-based devices.

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

Not applicable/Not specified. (See point 8.)

Summary

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NOV 1 3 2000

K002677

Section VII

510(k) Summary

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KO02677

VII. 510(k) Summary

In accordance with the Safe Medical Devices Act (SMDA) of 1990 and Title 21 of the Code of Federal Regulations, Part 807), and in particular $807.92, the following summary of information is provided:

A. Submitted by:

R. Stephen Reitzler, RAC Vice President, Regulatory Affairs and Quality Assurance NuVasive, Incorporated 10065 Old Grove Road, Suite A San Diego, California 92131 Telephone: (858) 271-7070 Telefacsimile: (858) 271-7101

B. Device Name

Trade or Proprietary Name: INS-1 Introperative Nerve Surveillance System

Common or Usual Name: Electromyography (EMG) monitor/stimulator

Classification Name: Surgical nerve stimulator/locator

C. Predicate Devices

The subject device is substantially equivalent, in whole or in part, to one or more of the following predicate devices, among others:

Brackmann IITM EMG Monitoring System (WR Medical Electronics Co.) Neurovision SE Nerve Locator/Monitor (RLN Systems, Inc.) Viking IV™ Electromyography System (Nicolet Biomedical) Epoch 2000 Neurological Workstation (Axon Systems, Inc.) Neurosign 400 Motor Nerve Monitor (Magstim Company, Ltd.)

D. Device Description

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The device employs a "Status" routine to determine the baseline functional status of exiting spinal nerves in the area of the operative target, and directs low amperage current through the distal tip of the NuVasive Expanding Cannula as it penetrates tissue to the operative target.

Through a series of EMG electrodes placed on the muscle groups associated with the spinal nerves at the operative level of the spine, the INS-1 System monitors EMG activity in these muscle groups and, when the Cannula tip draws sufficiently near to one such nerve that the electrical energy it emits is strong enough to depolarize the nerve and create an EMG response, alerts the surgeon that the Cannula tip is in proximity to that nerve.

An additional feature of the INS-1 System is a hand-held electrical probe which can assist the surgeon in determining if a nerve lies directly in the path of the instrumentation, and may also be used to ascertain whether a transpedicular screw has violated the pedicle wall.

The INS-1 System consists of a reusable Control Unit and PreAmp module, and an assortment of disposable and reusable conductive probe cables, electrodes, and electrode leads.

E. Intended Use

F. Comparison to Predicate Devices

The subject device has indications for use which are substantially equivalent to those of one or more of the predicate devices, is composed of the same or equivalent materials as one or more commercially marketed devices, has the same design features as one or more of the predicate devices, and has functional characteristics which are the same or equivalent to those of one or more of the predicate devices. Due to the equivalency of indications for use, materials of composition, design features, method of use, and functional characteristics, the device raises no new safety or effectiveness issues.

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Summary of Non-Clinical Tests G.

Animal studies conducted in the porcine model have established that 1) the principle functions of the INS-1 System are effectively performed, such that spinal nerve status and location may be ascertained and monitored, and 2) that the data acquired by the subject device during simulated surgical use in the animal model correlate well with those acquired simultaneously by a predicate device.

H. Summary of Clinical Tests

(Not applicable.)

Conclusions of Non-Clinical and Clinical Tests I.

The subject device is substantially equivalent in function to that of at least one predicate device.

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Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS) in the USA. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it, representing medicine and healing. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 3 2000

Mr. R. Stephen Reitzler, RAC Vice President, Regulatory Affairs and Quality Assurance Nuvasive, Inc. 10065 Old Grove Road, Suite A San Diego, California 92131

Re: K002677

Trade Name: NuVasive INS-1 Intraoperative Nerve Surveillance System Regulatory Class: II Product Code: BXM Dated: August 24, 2000 Received: August 28, 2000

Dear Mr. Reitzler:

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 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). You may, therefore, market the device, subject to the general controls provisions of the Act. However, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit/tray. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and labeling, and prohibitions 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 (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may

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Page 2 - Mr. R. Stephen Reitzler, RAC

result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish fesuit in regulatory action. In adamon, and the Federal Register. Please note: this further alliouncements concerning your submission does not affect any obligation you might have under sections 531 through 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(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed notherion. The FDA intellig of succeantar equir device and thus, permits your device to proceed to the market. If you desire specific advice for your device on the labeling regulation proceed to the marker. If you active op 10 for in vitro diagnostic devices), please contact the (21 CFR Fall and additionally, 8579. Additionally, for questions on the promotion and Office of Comphance at (301) >> contact the Office of Compliance at (301) 594-4639. Also, advertising of your device, prease contact and by reference to premarket notification' (21 CFR ( please note the regulation chance, "Misonations of the Act may be obtained from 1000 for and 607.97). Other general miormation on Joan Its toll free number (800) 638-2041 or (301) the Division of Unian Frien address "http://www.fda.gov/cdrb/dsma/dsmamain.html".

Sincerely yours,

Maik n muller

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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V. Draft Labeling

A. Indications for Use

510(k) Number (if known): 11 00 2677

Device Name: NuVasive INS-1 Intraoperative Nerve Surveillance System

Indications for Use:

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K00267-

Regulation Number and Section

§ 868.2775 Electrical peripheral nerve stimulator.

(a)
Identification. An electrical peripheral nerve stimulator (neuromuscular blockade monitor) is a device used to apply an electrical current to a patient to test the level of pharmacological effect of anesthetic drugs and gases.(b)
Classification. Class II (performance standards).