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. The device provides information directly to the surgeon to help assess a patient's neurophysiologic status by measuring and comparing MMG signals throughout a surgical procedure.

Device Description

SENTIO MMG Gen 2 is a multichannel device for locating, mapping and assessing the status of motor nerves during surgical procedures. SENTIO MMG Gen 2 alerts the user of recorded mechanical activity (termed mechanomyography, or MMG) from muscles innervated by affected nerves, which may originate from operator applied electrical stimulus or unintentional innervation of the nerve as a result of nerve impact, retraction, compression, or other mechanical factors. The device will assist with nerve identification and assessment by alerting the surgeon when monitored nerves are activated. The device will also assist with tracking the status of monitored nerves throughout the course of surgical intervention. The Sentio MMG Gen 2 system consists of capital equipment and disposable devices, both sterile and non-sterile.

AI/ML Overview

The provided text describes the SENTIO MMG Gen 2, a surgical nerve stimulator/locator that uses mechanomyographic (MMG) signals and electrical stimuli to assist in locating and mapping motor nerves during surgery. The submission to the FDA focuses on demonstrating substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of acceptance criteria and the reported device performance

The document does not explicitly present a table of specific acceptance criteria. Instead, it generally states that the device's technological characteristics, performance, and intended use are consistent with the predicate device. It also mentions that the device "meets the same acceptance criteria and conforms to the same consensus standards as the primary predicate device" for certain attributes.

For "enhanced MMG signal acquisition," it notes that this "does not raise new questions of safety and effectiveness based on results of bench testing and comparative performance evaluation." Furthermore, for the "Number of Channels," it states "Enhanced signal acquisition in comparison to primary predicate - Substantially equivalent to secondary predicates for same purpose of detecting a muscle event as evidenced by comparative performance evaluation."

Therefore, based on the provided text, the acceptance criteria are implicitly linked to demonstrating substantial equivalence to the predicate devices and conformity to recognized consensus standards, with performance being "as well as the predicate devices."

Feature/Attribute	Acceptance Criteria (Implicit)	Reported Device Performance
Indications for Use	Consistent with predicate devices; no new questions of safety or effectiveness.	Substantially equivalent; differences do not change intended use or raise new questions of safety or effectiveness, as demonstrated by risk-based verification and validation testing.
Capital Equipment (Control Unit & PC/Display)	Enhanced signal acquisition does not raise new safety/effectiveness questions; substantially equivalent for detecting muscle events. Meets same acceptance criteria and consensus standards as predicate for display size and weight.	Enhanced signal acquisition does not raise new questions of safety and effectiveness based on bench testing and comparative performance evaluation. Substantially equivalent to secondary predicates for detecting muscle events. Meets same acceptance criteria and conforms to same consensus standards as primary predicate for display size and weight.
System Stimulation (Ranges, Control, Voltage, Waveform, Pulse Width, Rate)	Ranges same as or within predicate/reference devices; same intended function. Same as primary predicate or within ranges/less than for secondary/reference.	Substantially equivalent; ranges are the same as, or within, the ranges of the primary predicate device, secondary predicates, or reference device and have the same intended function. Maximums are within limit settings. Same as primary predicate for waveform and pulse width also substantially equivalent to predicates/reference. Same as primary predicate and same or less than secondary predicates/reference for stimulation rate.
Sensors (Signal, Attachment, Size, Connector, Technology, Operating Voltage)	Same signal type, attachment site as primary predicate. Same performance criteria with reduced size. Substantially equivalent connector type and technology with same performance requirements. Meets same performance with lower voltage.	Same as primary predicate for signal and attachment site. Same performance criteria with reduced site attachment for size. Substantially equivalent connector type (3.5mm stereo plug) and technology (Digital) as evidenced by comparative performance evaluation. Substantially equivalent operating voltage (1.8V vs 3.3V) - lower power consumes less energy yet meets same performance.
Overall Performance	Performs as well as predicate devices and/or conforms to recognized consensus standards.	Performs as well as the predicate devices and/or conforms to recognized consensus standards for operating conditions, electrical safety, electromagnetic compatibility, hardware and disposable device functionality, signal acquisition equivalence, comparative performance evaluation, biocompatibility, shelf-life, sterilization, packaging integrity, and software validations.

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

The document states "comparative performance evaluation using clinically relevant MMG signal simulation to capture a statistically significant sample to demonstrate high agreement with respect to performance of the primary predicate."

Sample Size for Test Set: "statistically significant sample" - Specific numerical sample size is not provided.
Data Provenance: "clinically relevant MMG signal simulation" - This indicates the use of simulated data, not directly patient-derived data from a specific country. This is a retrospective approach as it evaluates the device against pre-defined simulations rather than collecting new patient data.

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

The document does not mention the use of human experts to establish ground truth for the test set. The validation seems to rely on "clinically relevant MMG signal simulation" and comparison to predicate device performance.

4. Adjudication method for the test set

Not applicable, as no human experts are mentioned for establishing ground truth or adjudication in the test set.

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 comparative effectiveness study involving human readers or AI assistance is mentioned in the provided text. The device is a "Surgical Nerve Stimulator/Locator" that provides information directly to the surgeon, but the study described is a non-clinical performance evaluation, not a human readability study.

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

Yes, the described "comparative performance evaluation using clinically relevant MMG signal simulation" focused on the device's ability to "detect a muscle event" and its "signal acquisition equivalence." This constitutes a standalone performance evaluation of the device's technical characteristics without human operators in a clinical setting; the output of the device is then interpreted by the surgeon.

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

The ground truth for the device's performance assessment appears to be based on pre-defined "clinically relevant MMG signal simulation" models which are designed to represent actual physiological signals. This is implicitly referenced in the statement "comparative performance evaluation using clinically relevant MMG signal simulation to capture a statistically significant sample to demonstrate high agreement with respect to performance of the primary predicate." The primary predicate's performance presumably serves as a benchmark for this simulated ground truth.

8. The sample size for the training set

The document does not mention a "training set" or machine learning being used in the development or evaluation of the device. The evaluation is described in terms of "non-clinical testing" and comparison to a predicate device.

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

Not applicable, as no training set or machine learning is mentioned.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters FDA in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

April 5, 2018 Medos International, SARL % Anna D'lima Senior Regulatory Affairs Program Lead DePuy Synthes 325 Paramont Drive Raynham, Massachusetts 02767

Re: K173526

Trade/Device Name: SENTIO MMG Gen 2 Regulation Number: 21 CFR 874.1820 Regulation Name: Surgical Nerve Stimulator/Locator Regulatory Class: Class II Product Code: PDQ, ETN Dated: March 1, 2018 Received: March 5, 2018

Dear Anna D'lima:

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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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.

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Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

William J. Heetderks -S 2018.04.05 16:43:21 -04'00'

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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Indications for Use

510(k) Number (if known) K173526

Device Name SENTIO MMG Gen 2

Indications for Use (Describe)

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)

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510(K) SUMMARY K173526

A. Submitter Information

Manufacturer:	Medos International SARLChemin-Blanc 382400 Le Locle, Switzerland
Submitter:	DePuy Spine, Inc.325 Paramount DriveRaynham, MA 02767
Contact Person:	Anna D'Lima325 Paramount DriveRaynham, MA 02767
Telephone number:	508-977-3896
Fax number:	508-828-3797
Email:	adlima@its.jnj.com

B. Date Prepared

April 02, 2018

C. Device Name

Trade/Proprietary Name:	SENTIO MMG® Gen 2
Common/Usual Name:	Surgical Nerve Stimulator/Locator
Device Classificationand Regulation:	Class II per 21 CFR §874.1820
Product Code and Description:	PDQ; Neurosurgical Nerve LocatorETN; Stimulator, Nerve

D. Predicate Device Name

Primary:	SENTIO MMG (K131304)
Other:	NuVasive Next Generation NVM5 System (K162313), STIMPODNMS450 Nerve Stimulator (K102084)
ReferenceDevice:	NIM-Spine (K031510), predicate to original SENTIO MMGsubmission (K100992)

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E. Device Description

Stimulus Modes	Standard(Monopolar)	Bipolar	Train of Four
Current Ranges	0-20 mA	0-2 mA	20-80 mA
CurrentAdjustment	1 mA	0.1 mA	5 mA
StimulationVoltages	115 V	27 V	350 V
Waveform	Monophasicsquare pulse	Monophasicsquare pulse	Monophasicsquare pulse
Pulse Width	50-250 µs	50-250 µs	100-200 µs
Pulse Rate	4 Hz, Continuous	4 Hz, Continuous	2 Hz, 4 Pulse burst
Nerve MappingProbe	Single-use, sterile accessory used to provide electricalstimulation to the surgical site
MMG Sensor	Single-use, non-sterile three-dimensional accelerometerdesigned to provide feedback for locating and mapping motornerves
AC Power Supply	Delta MDS-060AAS12 B
Weight	Tablet: 0.68 KgControl Unit: 0.72 Kg
Dimensions	Tablet: 291 mm (D) x 193 mm (W) x 8 mm (H)Control Unit: 220 mm (D) x 140 mm (W) x 40 mm (H)

E. Technological Characteristics

G. Indications for Use / Intended Use

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H. Summary of Similarities and Differences in Technological Characteristics, Performance and Intended Use

The intended use and technological characteristics, including material, design, and performance, of SENTIO MMG Gen 2 are consistent with those of the predicate device. The different user interface and enhanced MMG signal acquisition do not raise new questions of safety and effectiveness based on results of bench testing and comparative performance evaluation.

Attribute	Substantial Equivalence Evaluation
Indicationsfor Use	Substantially equivalent - The indications for use statement for theSENTIO MMG Gen 2 is a combination of the primary and secondarypredicate devices. The differences do not change the intended use asa surgical nerve stimulator / locator, nor raise new questions of safetyor effectiveness as demonstrated by results of the risk-basedverification and validation testing.
CapitalEquipment:Control UnitandPC/DisplayCapitalEquipment:Control UnitandPC/Display(continued)	Number of Channels - Enhanced signal acquisition in comparison toprimary predicate - Substantially equivalent to secondary predicatesfor same purpose of detecting a muscle event as evidenced bycomparative performance evaluation.User interface - Touchscreen Tablet PC - Same as the primarypredicate, substantially equivalent to secondary predicates with thesame functional specification (system operation).Display Size - Substantially equivalent - Subject device meets thesame acceptance criteria and conforms to the same consensusstandards as the primary predicate device.Weight - Substantially equivalent - Subject device meets the sameacceptance criteria and conforms to the same consensus standardsas the primary predicate device.Audio - Same as primary predicate and substantially equivalent tosecondary predicates.
SystemStimulation	Type Constant - Constant Current (mA) - Same as primary predicate.Stimulus Range - Standard (monopolar), Bipolar Mode, Train of Four- Substantially equivalent - Ranges are the same, or within, theranges of the primary predicate device, secondary predicates, orreference device and have the same intended function.Control - Digitally controlled, incremental adjustment - Standard(monopolar), Bipolar Mode, Train of Four, or selectable range viatouchscreen - Same as primary predicate.Maximum Stimulation Voltage - Substantially equivalent - Maximumsare within the limit settings of the primary predicate device, secondarypredicates, or reference device and have the same intended function.Waveform - Monophasic square pulse - Same as primary predicate.Pulse Width - Standard (monopolar), Bipolar Mode, Train of Four -Same as primary predicate - Substantially equivalent - Ranges arethe same, or within, the ranges of the primary predicate device,secondary predicates, or reference device and have the sameintended function.Stimulation Rate - Same as the primary predicate and the same orless than the secondary predicates and reference device.
Attribute	Substantial Equivalence Evaluation
Activation - Touchscreen or hand switch - Same as the primarypredicate.
Sensors	Signal (electromechanical) - Same as primary predicate.Attachment Site - Skin surface - Same as primary predicate.Size - Reduced size for smaller site attachment - Same performancecriteria with reduced site attachment.Connector type - 3.5mm Stereo plug - Substantially Equivalent -3.5mm plug is independent of orientation. Same performancerequirements.Technology - Digital - Substantially Equivalent as evidenced bycomparative performance evaluation.Operating Voltage - 1.8V compared to 3.3V - Substantially Equivalent- lower power consumes less energy for operation yet meets thesame performance.
StimulatorProbe	Same as primary predicate.
GroundPatch	Attachment Site - Skin surface - Same as primary predicate.Size - Same as primary predicate.Connector Type - 1.5mm touch proof - Industry standard DIN 42-802.
Materials	Capital equipment is comprised of materials evidenced to be suitedfor their specified purpose.Stimulator Probe is biocompatible and the same as the primarypredicate.Sensors are biocompatible and comprised of the same, or provenequivalent materials.Ground Patch is biocompatibility and comprised of the same, orproven equivalent materials.

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l. Performance Data

Non-clinical testing was conducted in accordance with Design Controls and Risk Management to confirm device performance for its intended use. The test results demonstrate that the device performs as well as the predicate devices and/or conform to recognized consensus standards for the compared design inputs, including, but not limited to; operating conditions, electrical safety, electromagnetic compatibility, hardware and disposable device functionality, signal acquisition equivalence, comparative performance evaluation using clinically relevant MMG signal simulation to capture a statistically significant sample to demonstrate high agreement with respect to performance of the primary predicate, biocompatibility, shelf-life, sterilization, packaging integrity, and software validations.

J. Conclusion

The indications for use and intended use of the subject device are consistent with those of the predicate devices. Comparison of technological characteristics and results of performance testing demonstrate substantial equivalence with the predicate devices.

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.