This device is intended for use in surgical procedures to assist in locating and mapping motor nerves through the use of mechanomyographic (MMG) signals and electrical stimulus of nerves. This device is indicated for locating and identifying spinal nerve roots and peripheral motor nerves originating from spinal levels C3-T1 and L2-S2.

Device Description

The NeuralMAS™ system is a multichannel intraoperative monitor for use during surgeries in which a motor nerve is at risk. The NeuralMAS™ system records mechanomyographic (MMG) signals from muscles innervated by the affected nerve, which may originate from operator applied electrical stimulus or from direct or indirect mechanical stimulus occurring during the course of surgery. The monitor will assist early nerve identification by providing the surgeon with a tool to help locate and identify the particular nerve at risk to minimize trauma by alerting the surgeon when a particular nerve has been activated.

The NeuralMAS™ system consists of a reusable Patient Module, a Control Unit comprised of a touch-screen PC and an assortment of disposable conductive probes, stimulators, sensors, electrodes and electrode leads.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study details for the NeuralMAS™ device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state pre-defined acceptance criteria in terms of specific performance metrics (e.g., minimum sensitivity or specificity targets). Instead, the study's acceptance was based on demonstrating "statistical agreement" and "correlation" with a predicate device.

Acceptance Criteria (Implied)	Reported Device Performance
Statistical agreement with predicate device	Results for positive and overall percent agreement established that: 1) The NeuralMAS™ system's principle functions are effective for ascertaining and monitoring spinal nerve status and location. 2) Data acquired by NeuralMAS™ during simulated surgical use in an animal model correlate well with data acquired simultaneously by a predicate device.
Effectiveness of principle functions	Demonstrated effectiveness in ascertaining and monitoring spinal nerve status and location.
Correlation of acquired data with predicate device	Good correlation between data acquired by NeuralMAS™ and data acquired simultaneously by a predicate device in an animal model.
Safety and effectiveness comparable to predicate device	Concluded to be "as safe, as effective and performs as well as the legally marketed predicate device."
Substantial equivalence in function to predicate device	Concluded to be "substantially equivalent in function to the legally marketed predicate device."

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

Sample Size: Not explicitly stated. The study mentions a "comparative performance evaluation was conducted in the sheep," implying a limited animal study, but the specific number of sheep or cases is not provided.
Data Provenance: Prospective animal study conducted in "sheep" (animal model). The country of origin is not specified, but the submission is to the US FDA, so it's likely a US-based study or one adhering to US regulatory standards.

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

Not applicable. The study was a comparative performance evaluation between the subject device and a predicate device in an animal model, not an assessment against human-established ground truth. The "ground truth" was essentially the synchronous readings from the predicate device and the physiological responses observed during the animal experiment.

4. Adjudication Method for the Test Set

Not applicable. There was no mention of human expert adjudication for the animal study. The comparison was statistical agreement and correlation between the two devices.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. The study described is a non-clinical animal study comparing the device to a predicate, not an MRMC study involving human readers.

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

Yes, in essence. The "comparative performance evaluation" in the sheep assessed the device's ability to ascertain and monitor nerve status and location, and its data acquisition, in direct comparison to the predicate device. This is a standalone assessment of the device's functional performance in a simulated surgical environment. Human interpretation or intervention as part of the performance measurement itself (beyond setting up and operating the devices) is not indicated.

7. The Type of Ground Truth Used

The "ground truth" for the test set was the data simultaneously acquired by the predicate device and the directly observable physiological responses in the animal model. The study aimed to show correlation and agreement between the NeuralMAS™ and the predicate device's readings. It did not rely on a separate, independent "gold standard" or pathology.

8. The Sample Size for the Training Set

Not applicable. This is a 510(k) submission for a medical device that records mechanomyographic signals and uses electrical stimulation. The device itself is not described as involving a machine learning algorithm that requires a "training set" in the traditional sense. The "training" for the device would have involved engineering development and calibration, not a data-driven machine learning training set as would be found in AI/ML device submissions.

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

Not applicable, as there's no mention of a traditional machine learning training set for this device.

Summary

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510(K) SUMMARY

2 4 2010 SEP

Page .

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

Submitter's Identification: 1.

Christopher Wybo Director of Engineering and Regulatory Innovative Surgical Solutions, LLC 1002 Hoffman Ave. Royal Oak, MI 48067 Tel: (248) 416-0740 Fax: (800) 683-8144

Date Summary Prepared: September 24, 2010

Name of the Device: 2.

Trade or Proprietary Name:	NeuralMAS™
Classification Name:	Surgical Nerve Stimulator/Locator
Device Class:	Class II
Classification:	21 CFR §874.1820
Product Code:	ETN

Common or Usual Name: 3.

(MMG) Mechanomyographic System, Intraoperative Avoidance Mapping and Nerve Monitor/Stimulator, Nerve Locator/Stimulator

Predicate Device Information: 4.

The subject device NeuralMAS™ is substantially equivalent to one or more of the following predicate devices:

NIM-Spine, Medtronic Xomed, Jacksonville, Florida K031510
Rhythmlink, Columbia, South Carolina K072736
Axon Systems, Hauppauge, New York KO62996
UniPlex Nanoline Cannula, Pajunk GMBH, Geisingen, Germany K000722

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Page L

5. Device Description:

Intended Use: 6.

Comparison to Predicate Devices: 7.

The subject device has indications for use which are substantially equivalent to the predicate device, is composed of the same or equivalent materials as one or more commercially marketed devices, has the same or equivalent design features as the predicate device, is substantially equivalent in its method of use, 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.

NeuralMAS™ Nerve Mapping & Avoidance System

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Table 1: Overview & Indications

Subject Device:	Predicate Device:
ISS NeuralMAS	Medtronic NIM-Spine #K031510
System Overview	System Overview
Uses low level electrical current to stimulatenerves sufficient to produce a detectablemechanical signal in contracting muscle usingskin-surface mounted mechanomyographic(MMG) sensors.	Uses electrical current varying betweenlow and high levels to induce current flowin stimulated nerves sufficient to produce adetectable electrical signal in contractingmuscle using EMG needle electrodesplaced in the muscle.

Table 2: Physical Attributes

Attribute	ISS NeuralMAS	Medtronic NIM-Spine#K031510
Control Module: PC/Display
Type:	Touchscreen	Touchscreen
Number of Channels:	10	8
ChannelEnable/DisableControls:	Touchscreen controlled	Dedicated function touchpads forindependent channelenable/disable
Event ThresholdControl and Display:	Touchscreen controlled	Adjustable graduated touchbarwith voltage threshold display
Stimulator
Type Constant:	Electrical Current (mA)	Electrical Current (mA)
Range:	1-15 mA	1-200 mA, max 540V compliant
Control:	Digitally controlled	Digitally controlled
Waveform:	Monophasic, square pulse	Monophasic, square pulse
Pulse Duration:	100µs	50, 100, 150, 200 or 250µs

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Rate:	2Hz	Switch selectable: 1, 5, or 10Hz
Stimulus Probe:	Monopolar	Monopolar or bipolar
Activation:	Touch screen or hand switch	Two step touch screen or handswitch
Monitoring Sensor
Function:	Mechanomyographic (MMG)	Electromyographic (EMG)
Type:	Electromechanical	Subdermal needle electrodes
Attachment Site:	Skin surface	Subdermal

Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as 8. follows:

A comparative performance evaluation was conducted in the sheep to assess statistical agreement between the subject device and the predicate. Results for positive, and overall percent agreement have established that 1) the principle functions of the NeuralMAS™ system are effective, such that spinal nerve status and location may be ascertained and monitored, and 2) 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.

Discussion of Clinical Tests Performed: ರು

Not Applicable

10. Conclusions:

The conclusions drawn from our non-clinical testing (to include our animal testing) of the subject device demonstrates that the subject device is as safe, as effective and performs as well as the legally marketed predicate device. The subject device is substantially equivalent in function to the legally marketed predicate device.

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Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized bird in flight, composed of three curved lines, symbolizing health and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular fashion around the bird.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Innovative Surgical Solutions, LLC c/o Ms. Susan Goldstein-Falk MDI Consultants, Inc. 55 Northern Boulevard, Suite 200 Great Neck, New York 10021

Re: K100992

Trade/Device Name: NeuralMAS Regulation Number: 21 CFR 874.1820 Regulation Name: Surgical Nerve Stimulator/Locator Regulatory Class: Class II Product Code: ETN Dated: August 27, 2010 Received: September 1, 2010

Dear Ms. Goldstein-Falk:

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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

SEP 24 2010

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Page 2 - Ms. Susan Goldstein-Falk

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Robinm.k

Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K100992

Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

SEP 2 4 2010

Device Name: NeuralMAS

Indications For Use:

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

signature

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

100992

Prescription Use
(Per 21 CFR 801.109)

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.