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 Sentio MMG® system is a multichannel intraoperative monitor for use during surgeries in which a motor nerve is at risk. The Sentio MMG® system records mechanomyographic (MMG) signals from muscles innervated by the affected nerve, which may originate from operator applied electrical stimulus or from direct 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 Sentio MMG® system consists of a reusable Control Unit comprised of a touch-screen PC and Patient Module, a reusable Sensor Connector Module 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 Sentio MMG® Neurosurgical Nerve Locator, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary states that a "comparative performance evaluation was conducted to assess statistical agreement between the subject device and the predicate." It then concludes that "Results for positive, and overall percent agreement have established that 1) the principle functions of the Sentio MMG® system are effective, such that spinal nerve status and location may be ascertained and monitored, and 2) the data processed by the subject device following surgical use correlate well with those acquired by the predicate device."

However, specific numerical acceptance criteria (e.g., minimum percentage agreement, sensitivity, specificity, or specific statistical thresholds) are not explicitly provided in the document for the new device. The acceptance is based on demonstrating "substantial equivalence" to the predicate device (K100992 NeuralMAS™). This implies that the performance of Sentio MMG® must be comparable to or better than the predicate's established performance without raising new safety or effectiveness concerns.

Performance Metric	Acceptance Criteria (Implicit)	Reported Device Performance
Principal Functions Effectiveness	Spinal nerve status and location can be ascertained and monitored effectively.	Established as effective.
Data Correlation	Data processed by the subject device following surgical use correlate well with those acquired by the predicate device.	Correlate well with predicate device data for positive and overall percent agreement.
Safety and Effectiveness	Equivalent to or better than the predicate device, with no new issues raised.	Demonstrated to be as safe, as effective, and performs better than the legally marketed predicate device.

2. Sample Size and Data Provenance

The document does not explicitly state the sample size used for the comparative performance evaluation or the data provenance (e.g., country of origin, retrospective/prospective). It only refers to "market data evaluation" and "non-clinical testing." This often implies internal testing or possibly data collected from the predicate device's use in the market.

3. Number of Experts and Their Qualifications

The document does not mention the involvement of experts for establishing ground truth or evaluating the test results. The assessment relied on statistical agreement between the subject device and the predicate device.

4. Adjudication Method

No adjudication method is mentioned in the document. The comparative evaluation appears to be a direct comparison of the subject device's output against the predicate device's output.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC study was done, as this is a device that directly measures physiological signals rather than an imaging device requiring human interpretation of images. The device assists in locating and mapping motor nerves, and its performance is evaluated based on its signal output compared to a predicate device.

6. Standalone (Algorithm Only) Performance

A standalone performance evaluation was conducted in the sense that the device's output was statistically compared to the predicate device's output. This is not an "algorithm only" in the context of AI, but rather the device's functional performance in isolation of human decision-making based on the output. The conclusion states: "The conclusions drawn from our non-clinical testing (to include our market data evaluation) of the subject device demonstrates that the subject device is as safe, as effective and performs better than the legally marketed predicate device."

7. Type of Ground Truth Used

The "ground truth" for the comparative study appears to be the performance and data acquired by the predicate device (ISS NeuralMAS #K100992). The study assessed the "statistical agreement" between the subject device's output and the predicate device's output. This is a comparison to a previously cleared device's performance, not an independent clinical ground truth like pathology or expert consensus on nerve presence.

8. Sample Size for the Training Set

The document does not mention a "training set" as this device is not described as an AI/machine learning product in the traditional sense that requires complex algorithm training. The comparison is against an existing predicate device's functionality.

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

Not applicable, as no training set (in the AI/ML sense) is mentioned or implied for this non-clinical testing. The "ground truth" for the comparison was the predicate device's established performance.

Summary

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510(K) SUMMARY

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.

· 1. Submitter's Identification:
Aashish Shah Vice President of Quality & Operations Sentio, LLC 50461 W Pontiac Trail Wixom, MI 48393 Tel: (248) 595-0420 Fax: (248) 956-8123

Date Summary Prepared: April 29th, 2014

2. Name of the Device:

Trade or Proprietary Name: Classification Name: Device Class: Classification: Product Code:

Sentio MMG® Neurosurgical Nerve Locator Class II 21 CFR §874.1820 PDQ

Common or Usual Name: 3.

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

Predicate Device Information: .4.

The subject device Sentio MMG® is substantially equivalent to the following predicate device:

K100992 NeuralMAS™, Innovative Surgical Solutions, LLC d/b/a Sentio, LLC, Wixom, Michigan

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Device Description: 5.

Intended Use: ર.

7. Comparison to Predicate Devices:

The subject device has indications for use which are the same as the predicate device, K100992, is composed of the same materials as the predicate commercially marketed device, has the same or equivalent design features as the predicate device, is substantially equivalent in its method of . use, incorporates the same fundamental scientific technology and has functional characteristics which are the same or equivalent to those of the predicate device. Due to the equivalency of indications for use, materials of composition, design features, method of use, scientific technology and functional characteristics, the device raises no new safety or effectiveness issues.

A comparison of the technological characteristics to the predicate device is provided below:

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Table 1: Overview & Indications

Subject Device:	Predicate Device:
Sentio MMG® #K131304	ISS NeuralMAS #K100992
System OverviewUses low level electrical current to stimulatenerves sufficient to produce a detectablemechanical signal in contracting muscle usingskin-surface mounted mechanomyographic(MMG) sensors.	System OverviewUses low level electrical current to stimulate nerves sufficient to produce adetectable mechanical signal in contractingmuscle using skin-surface mountedmechanomyographic (MMG) sensors.

Table 2: Physical Attributes

Attribute	Sentio MMG®#K131304	ISS NeuralMAS#K100992
Control Module: PC/Display
Type:	Touchscreen	Touchscreen
Number of Channels:	10	10
ChannelEnable/DisableControls:	Touchscreen controlled	Touchscreen controlled
Event ThresholdControl and Display:	Touchscreen controlled	Touchscreen controlled
Stimulator
Type Constant:	Electrical Current (mA)	Electrical Current (mA)
Range: Control:	1-15 mA	1-15 mA
Waveform:	Digitally controlled	Digitally controlled
Pulse Duration:	Monophasic, square pulse	Monophasic, square pulse
	100μς	100μς

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Rate:	2Hz	2Hz
Stimulus Probe:	Monopolar	Monopolar
Activation:	Touch screen or hand switch	Touch screen or hand switch
Monitoring Sensor
Function:	Mechanomyographic (MMG)	Mechanomyographic (MMG)
Type: Attachment	Electromechanical	Electromechanical
Site: Attachment	Skin surface	Skin surface
Mode:	Adhesive	Adhesive

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

A comparative performance evaluation was conducted 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 Sentio MMG® system are effective, such that spinal nerve status and location may be ascertained and monitored, and 2) the data processed by the subject device following surgical use correlate well with those acquired by the predicate device.

9. Discussion of Clinical Tests Performed:

Not Applicable

10. Conclusions:

The conclusions drawn from our non-clinical testing (to include our market data evaluation) of the subject device demonstrates that the subject device is as safe, as effective and performs better than the legally marketed predicate device. Any noted differences between the devices are minor and do not raise new issues of safety and effectiveness. The subject device is substantially equivalent to the legally marketed predicate device.

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Public Health Service

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

May 29, 2014

Innovative Surgical Solutions, LLC Mr. Aashish Shah Vice President Quality & Operations 21520 Bridge Street Southfield, MI 48033

Re: K131304

Trade/Device Name: Sentio MMG Regulation Number: 21 CFR 874.1820 Regulation Name: Neurosurgical Nerve Locator Regulatory Class: Class II Product Code: PDQ Dated: April 29, 2014 Received: April 30, 2014

Dear Mr. Shah:

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. 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.

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

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Page 2 - Mr. Aashish Shah

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education 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,

Felipe Aquel - S

for

Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510{k} Number (if known) K131304

Device Name

Sentio MMG

Indications for Use (Describe)

This device is intended for use in surgical procedures to assist in locating and mapping motor nerves through the use of mechanomyographic (MMO) 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.

Type of Use (Select one or both, as applicable)

∑ Prescription Use (Part 21 CFR 801 Subpart D)

■ Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

ം Date: 2014.05.29

22:30:24 -04'00'

EF PSC Publishing Scriptocs (30)) 443-6740

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

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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.