The NeuroStar Advanced Therapy System is indicated for the treatment of Major Depressive Disorder in adult patients who have failed to receive satisfactory improvement from prior antidepressant medication in the current episode.

Device Description

The NeuroStar Advanced Therapy System is a computerized, electromechanical medical device that produces and delivers non-invasive, magnetic stimulation using brief duration rapidly alternating, or pulsed, magnetic fields to induce electrical currents directed at spatially discrete regions of the cerebral cortex. This method of cortical stimulation by application of brief magnetic pulses to the head is known as Transcranial Maqnetic Stimulation (TMS). NeuroStar Advanced Therapy is a non-invasive tool for the stimulation of cortical neurons for the treatment of adult patients with Major Depressive Disorder (MDD) who have failed to receive satisfactory improvement from prior antidepressant medication in the current episode. NeuroStar Advanced Therapy is used for patient treatment by prescription only under the supervision of a licensed physician and can be used in both inpatient and outpatient settings including physician's offices, clinics, and hospitals. NeuroStar Advanced Therapy uses a well-understood property of physics regarding the law of electromagnetic induction, which states that a time-varying or moving magnetic field will induce an electric current in an adjacent conductive substance with the electric current traveling in a direction perpendicular to the motion of the magnetic field. NeuroStar Advanced Therapy uses a generated magnetic field as a vector for delivering an electrical current to a tarqet conductor of interest, which in therapeutic application, is the brain. By using this method of delivering electrical current to the brain the electrical current produced in the brain can be delivered in an anatomically focused manner at discrete cortical areas of interest and can avoid areas of the brain that are not relevant for its therapeutic actions.

The NeuroStar Advanced Therapy System is an integrated system consisting of a combination of the following components:

Mobile Console for housing the electronics and includes a software . controlled graphical user interface, display monitor, display arm, and gantry that supports the treatment coil.
Ferromagnetic Coil for delivering treatment. .
. Head Support System for positioning the treatment coil and includes a laser-guided alignment system
. Optional MT Cap for
Multi-use consumable SenStar Treatment Link for contact sensing of the ● treatment coil with the patient's head and maqnetic field quality control.
TrakStar Patient Data Management System for recording patient data and includes a stand-alone computer and data management software

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the NeuroStar Advanced Therapy System, based on the provided FDA 510(k) summary:

The primary purpose of this 510(k) submission is for the addition of the MT Cap accessory. The document explicitly states that the NeuroStar Advanced Therapy System (the subject device) has the same indications for use and technological characteristics as the predicate device, implying that the core system's performance metrics have already been established in previous submissions. This K213543 submission focuses on the safety and effectiveness of the new accessory.

Therefore, the "acceptance criteria" and "device performance" in the context of this specific submission revolve around demonstrating that the MT Cap accessory does not negatively impact the existing performance or introduce new risks, and that it functions as intended to aid in the Motor Threshold Hunt process.

Acceptance Criteria and Reported Device Performance

Given that this 510(k) is an update for an accessory (MT Cap) to an already cleared device, the acceptance criteria are focused on demonstrating that the accessory does not compromise the device's safety or efficacy. The document does not provide specific quantitative performance metrics tied to sensitivity, specificity, accuracy, or similar measures typically found in standalone diagnostic AI/ML device acceptances. Instead, the "performance" demonstrated is compliance with relevant standards and successful usability.

Acceptance Criteria Category	Reported Device Performance
Biocompatibility (for MT Cap)	MT Cap material compliant with ISO 10993-1:2018; uses standard materials commonly used in consumer products and medical device applications.
Usability (for MT Cap integration)	Usability testing completed in accordance with IEC 60601-1-6:2010, Edition 3.1 and FDA Guidance Document "Applying Human Factors and Usability Engineering to Medical Devices." The MT Cap enables physicians to easily move the coil incrementally without adjusting the A/P Bar.
Safety - Electrical/EMC (overall system)	IEC 60601-1 compliant; IEC 60601-1-2 compliant (inherited from predicate device, not re-evaluated for MT Cap specifically as it's a passive accessory).
No New Questions of Safety or Effectiveness	The use of the optional MT Cap accessory "does not raise any new questions of safety or effectiveness." This is the overarching acceptance.
Functional Aiding of MT Hunt	MT Cap provides symmetrical grid for incremental coil movement and includes intersecting lines for starting point; aids in facilitating the hunt for the MT location.
No change to core treatment parameters	All core treatment parameters (%MT Range, PPS Range, Induced Electric Field, Pulse Type, Pulse Width, Treatment Protocols, Treatment Level Range) remain identical to the predicate device.

Study Information Specific to the MT Cap Accessory

Sample Size used for the test set and the data provenance:
- The document states, "There is no clinical testing required to support this submission."
- For Usability testing, the sample size is not explicitly stated in the provided text. Usability studies typically involve a small number of representative users (e.g., 8-15) as per human factors guidance, but the exact number is not here.
- The provenance for usability testing would typically be prospective, involving healthcare professionals interacting with the device/accessory. The document does not specify country of origin for usability test participants.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- As no clinical testing was required, there was no "ground truth" to establish in the traditional sense of disease diagnosis or outcome for the MT Cap.
- For usability testing, "experts" would be the healthcare professionals participating in the test. Their qualifications would typically involve experience with TMS procedures. The document does not specify the number or detailed qualifications of these individuals.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable as there was no clinical study with a diagnostic endpoint requiring adjudication. Usability studies use qualitative and quantitative measures of user performance, error rates, and satisfaction rather than adjudication of findings.
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 or comparative effectiveness study was done. This device is a hardware accessory (MT Cap) for a TMS system, not an AI/ML diagnostic or assistive algorithm. The MT Cap is a physical guide to assist in a manual process (Motor Threshold Hunt), not an AI.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. The MT Cap is a passive physical accessory, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable for the MT Cap accessory. For the overall NeuroStar system (established in prior submissions), ground truth for Major Depressive Disorder (MDD) efficacy would have been based on clinical assessments (e.g., Hamilton Depression Rating Scale, Montgomery-Åsberg Depression Rating Scale) and clinical outcomes, but this is not part of this submission.
The sample size for the training set:
- Not applicable as this is not an AI/ML device requiring a training set.
How the ground truth for the training set was established:
- Not applicable as this is not an AI/ML device requiring a training set.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which 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.

December 10, 2021

Neuronetics, Inc Fred Cowdery Director, Regulatory Affairs and Qulaity Assurance 3222 Phoenixville Pike Malvern, Pennsylvania 19355

Re: K213543

Trade/Device Name: NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar, NeuroStar Advanced Therapy for Mental Health Regulation Number: 21 CFR 882.5805 Regulation Name: Repetitive transcranial magnetic stimulation system Regulatory Class: Class II Product Code: OBP Dated: November 2, 2021 Received: November 8, 2021

Dear Fred Cowdery:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Pamela Scott Assistant Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known)

K213543

Device Name NeuroStar Advanced Therapy System

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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Image /page/3/Picture/0 description: The image is a logo for NeuroStar. The word "Neuro" is in purple, and the word "Star" is in teal. Below the word "NeuroStar" is the phrase "Advanced Therapy for Mental Health" in a smaller font. To the right of the word "NeuroStar" is a teal and purple graphic of three people holding hands in a circle.

510(k) Summary (As required by Section 807.92)

Date Prepared:	November 2, 2021
Applicant:	Neuronetics, Inc.3222 Phoenixville PikeMalvern, PA. 19355
Contact Person:	Fred CowderyDirector – Regulatory Affairs and Quality AssurancePh 610.981-4138Email: fred.cowdery@neurostar.com
Device Trade Name:	NeuroStarNeuroStar TMS Therapy SystemNeuroStar Advanced Therapy SystemNeuroStar Advanced Therapy for Mental Health
Device Name: Common:	Transcranial Magnetic Stimulation System
Classification:	21 CFR 882.5802, Transcranial Magnetic StimulationSystem for Neurological and Psychiatric Disordersand Conditions
Regulatory Class:	Class II Medical Device
Product Code:	OBP
Predicate Device(s):	NeuroStar Advanced Therapy System, K201158,

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Image /page/4/Picture/0 description: The image is a logo for NeuroStar. The word "Neuro" is in purple, and the word "Star" is in teal. Below the words is the phrase "Advanced Therapy for Mental Health" in a smaller font. To the right of the word "Star" is a teal and purple graphic of three people holding hands in a circle.

Device Description / Technological Characteristics:

The NeuroStar Advanced Therapy System is an integrated system consisting of a combination of the following components:

Mobile Console for housing the electronics and includes a software . controlled graphical user interface, display monitor, display arm, and gantry that supports the treatment coil.
Ferromagnetic Coil for delivering treatment. .
. Head Support System for positioning the treatment coil and includes a laser-guided alignment system
. Optional MT Cap for
Multi-use consumable SenStar Treatment Link for contact sensing of the ● treatment coil with the patient's head and maqnetic field quality control.
TrakStar Patient Data Management System for recording patient data and includes a stand-alone computer and data management software

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Image /page/5/Picture/0 description: The image is a logo for NeuroStar, a company that provides advanced therapy for mental health. The word "Neuro" is in purple, and the word "Star" is in teal. Above the word "Star" is a teal and purple star-shaped design with two people figures. Below the words "NeuroStar" is the phrase "Advanced Therapy for Mental Health".

Proposed Change:

The proposed change to the NeuroStar Advanced Therapy System is the addition of the a single use wearable device, namely the MT Cap Accessory, which provides an optional method to aid in the Motor Threshold Hunt process (MT Hunt).

lt is only worn during the MT Hunt (prior to the patient's first treatment session) as a quide to facilitate the hunt for the MT location.

The MT Cap outer surface contains a symmetrical grid printed with alternating colors, and includes two intersecting lines which indicate the MT Hunt starting point for coil positioning. The seam on the cap is aligned the patient's nasion and the edge of the cap is positioned above the patient's eyebrows.

The symmetrical grid printed on the outer surface of the MT Cap enables the physician to easily move the coil incrementally in the anterior and posterior directions without having to adjust the A/P Bar.

As pulses are delivered to the patient during the MT Hunt process, the treating physician monitors the patient hand for involuntary movement in exactly the same manner as the current method.

The SOA grid lines are then used to align the coil to deliver pulses in the SOA angle (i.e. medial/lateral directions). When each pulse is delivered, the treating physician is observing the patient hand for involuntary movement in exactly the same manner as the current method.

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Image /page/6/Picture/0 description: The image shows the logo for NeuroStar, a company that provides advanced therapy for mental health. The word "Neuro" is in purple, and the word "Star" is in teal. Above the word "Star" is a graphic of three people holding hands in a star shape, with the people in teal and purple. Below the words is the phrase "Advanced Therapy for Mental Health".

Intended Use:

The NeuroStar Advanced Therapy system is indicated for the treatment of Major Depressive Disorder in adult patients who failed to achieve satisfactory improvement from prior antidepressant medication in the current episode.

Performance Standards:

The NeuroStar Advanced Therapy system has been tested and conforms with the following recognized consensus standards:

IEC60601-1
IEC60601-1-2 .
ISO 10993-1:2018 .
IEC 60601-1-6:2010, Edition 3.1 .

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Image /page/7/Picture/0 description: The image shows the logo for NeuroStar. The word "Neuro" is in purple, and the word "Star" is in teal. Above and to the right of the word "Star" is a star-shaped graphic made of three figures holding hands. Below the words "NeuroStar" is the phrase "Advanced Therapy for Mental Health".

Non-Clinical Testing:

The contents of this 510(k) complies with the FDA Guidance Document: "Class II Special Controls Guidance Document: Repetitive Transcranial Magnetic Stimulation (rTMS) Systems - Guidance for Industry and Food and Drug Administration Staff". The non-clinical performance testing of the MT Cap was conducted according to ISO 10993-1:2018 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process.

Additionally, Usability testing was completed in accordance with IEC 60601-1-6:2010, Edition 3.1 and also following the FDA Guidance Document "Applying Human Factors and Usability Engineering to Medical Devices".

Clinical Testing:

There is no clinical testing required to support this submission.

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Image /page/8/Picture/0 description: The image is a logo for NeuroStar. The word "Neuro" is in purple, and the word "Star" is in teal. Below the words is the phrase "Advanced Therapy for Mental Health".

Technical Comparison:

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Image /page/9/Picture/0 description: The image is a logo for NeuroStar. The word "Neuro" is in purple, and the word "Star" is in teal. Above the word "Star" is a star shape with human figures at the points. Below the words is the phrase "Advanced Therapy for Mental Health."

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Image /page/10/Picture/0 description: The image is a logo for NeuroStar Advanced Therapy for Mental Health. The word "Neuro" is in purple, and the word "Star" is in teal. To the right of the word "Star" is a star-shaped figure with a person in the middle.

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Image /page/11/Picture/0 description: The image is a logo for NeuroStar. The word "Neuro" is in purple, and the word "Star" is in teal. The tagline "Advanced Therapy for Mental Health" is in a smaller font below the words NeuroStar. To the right of the word "Star" is a teal and purple star-shaped design.

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Image /page/12/Picture/0 description: The image shows the logo for NeuroStar. The word "Neuro" is in purple, and the word "Star" is in teal. To the right of the word "Star" is a teal star with a purple person figure at the top. Below the words "NeuroStar" is the phrase "Advanced Therapy for Mental Health".

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Image /page/13/Picture/0 description: The image is a logo for NeuroStar Advanced Therapy for Mental Health. The word "Neuro" is in purple, and the word "Star" is in teal. Above the word "Star" is a teal and purple star-shaped figure with a person in the middle.

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Image /page/14/Picture/0 description: The image is a logo for NeuroStar. The word "Neuro" is in purple, and the word "Star" is in teal. Below the words is the phrase "Advanced Therapy for Mental Health". To the right of the words is a teal and purple star-shaped design.

Conclusion:

The NeuroStar Advanced Therapy System and the primary predicate device have the same indications for use and the same technological characteristics. The use of the optional MT Cap accessory does not raise any new questions of safety or effectiveness.

Regulation Number and Section

§ 882.5805 Repetitive transcranial magnetic stimulation system.

(a)
Identification. A repetitive transcranial magnetic stimulation system is an external device that delivers transcranial repetitive pulsed magnetic fields of sufficient magnitude to induce neural action potentials in the prefrontal cortex to treat the symptoms of major depressive disorder without inducing seizure in patients who have failed at least one antidepressant medication and are currently not on any antidepressant therapy.(b)
Classification. Class II (special controls). The special control is FDA's “Class II Special Controls Guidance Document: Repetitive Transcranial Magnetic Stimulation System.” See § 882.1(e) for the availability of this guidance document.

Device Feature	Subject Device, NeuroStarAdvanced Therapy System	Predicate Device, NeuroStarAdvanced Therapy SystemK201158	Substantial EquivalenceRationale
Intended Use	Major Depressive Disorder	Major Depressive Disorder	Same
Indications forUse	Treatment of Major Depressive Disorderin adult patients who have failed toreceive satisfactory improvement fromprior antidepressant medication inthe current episode	Treatment of Major Depressive Disorderin adult patients who have failed toreceive satisfactory improvement fromprior antidepressant medication inthe current episode	Same
Population	Adult patients	Adult patients	Same
Materials	Standard materials commonlyused in the manufacture ofelectrical medical devices.	Standard materials commonlyused in the manufacture ofelectrical medical devices.	Same
Device Feature	Subject Device, NeuroStarAdvanced Therapy System	Predicate Device, NeuroStarAdvanced Therapy SystemK201158	Substantial Equivalence Rationale
Design	Computerized, electromechanicalmedical devices that use integratedsystems to deliver TMStherapy	Computerized, electromechanicalmedical devices that use integratedsystems to deliver TMStherapy	Same
Energy Source	Power console with magneticcoil for delivery of magneticenergy	Power console with magneticcoil for delivery of magneticenergy	Same
Biocompatibility	Patient-contacting device componentsuse standard materials compliant withISO10993-1:2018 that are commonlyused in consumer products and medicaldeviceapplications.	Patient-contacting device components usestandard materials compliant with ISO10993-1:2018 that are commonly used inconsumer products and medical deviceapplications	Same
Electrical SafetyEMC	IEC 60601-1 compliantIEC 60601-1-2 compliant	IEC 60601-1 compliantIEC 60601-1-2 compliant	Same
Device Feature	Subject Device, NeuroStarAdvancedTherapy System	Predicate Device, NeuroStarAdvancedTherapy SystemK201158	Substantial Equivalence Rationale
Sterility	No parts of the device, accessories, or components are required to be sterilized	No parts of the device, accessories, or components are required to be sterilized	Same
Coil Type	FerromagneticIron CoreInternal Cooling Fan	FerromagneticIron CoreInternal Cooling Fan	Same
Coil Positioning System	Integrated into Head SupportSystemLaser-Aided Coil Placement	Integrated into Head SupportSystemLaser-Aided Coil Placement	Same
Treatment Quality Features	Magnetic Field LevelDetection Coil ContactSensing	Magnetic Field LevelDetection Coil ContactSensing	Same
Anatomical Sites	Left Dorsolateral Prefrontal Cortex	Left Dorsolateral Prefrontal Cortex	Same
Device Feature	Subject Device, NeuroStarAdvanced Therapy System	Predicate Device, NeuroStarAdvanced Therapy SystemK201158	Substantial Equivalence Rationale
TreatmentRequirements	TMS Treatments5 days per week for 4 to 6weeksTotal of 20 to 30 treatmentsessions	TMS Treatments5 days per week for 4 to 6weeksTotal of 20 to 30 treatmentsessions	Same
DeviceComponents	Mobile ConsoleFerromagnetic Coil for delivering treatment.Head Support System for coil positioning.MT Cap for coil positioningMulti-use disposable for contact sensingand magnetic field quality control.TrakStar System for recording patient data	Mobile Console Ferromagnetic Coilfor delivering treatment.Head Support System for coil positioning.Multi-use disposable for contact sensingand magnetic field quality control.TrakStar System for recording patient data.	DifferentThe addition of the MT Cap accessory is the subject of this special 510K
%MT Range	25% to 140% MT	25% to 140% MT	Same
Device Feature	Subject Device, NeuroStarAdvanced Therapy System	Predicate Device, NeuroStarAdvanced Therapy SystemK201158	Substantial Equivalence Rationale
Pulses per Second(PPS)Range	For Treatment: 1 to 30 PPS For MTDetermination: 0.1 to0.3 PPS	For Treatment: 1 to 30 PPS For MTDetermination: 0.1 to0.3 PPS	Same
Induced ElectricField at 2 cm at1.0 SMT	135 V/m (Nominal)	135 V/m (Nominal)	Same
Pulse Type	Biphasic Sinusoid	Biphasic Sinusoid	Same
Pulse Width	185µS (Nominal)	185µS (Nominal)	Same
TreatmentProtocols	Standard Treatment Level: 120% MTwith allowable adjustmentsRepetition Rate: 10 PPS StimulationTime: 4 sec.Inter-train Interval: As low as11 sec.Session Duration: As low as18.75 min.Pulses per Session: 3000Sessions per Week: 5	Standard Treatment Level: 120% MTwith allowable adjustmentsRepetition Rate: 10 PPS StimulationTime: 4 sec.Inter-train Interval: As low as11 sec.Session Duration: As low as18.75 min.Pulses per Session: 3000Sessions per Week: 5	Same
Device Feature	Subject Device, NeuroStarAdvanced Therapy System	Predicate Device, NeuroStarAdvanced Therapy SystemK201158	Substantial Equivalence Rationale
	NeuroBurst Treatment Level: 80 -120% MT with allowable adjustmentsStimulation Time: 2 sec. Inter-trainInterval: 8 sec. Pulses per Burst: 3pulsesInterpulse Interval: 20 msPulses per Session: 600 SessionDuration: 3.3 min Bursts per Second: 5burstsAmplitude:0.22-2.08 SMT (≤ 5% drop)	NeuroBurst Treatment Level: 80 -120%MT with allowable adjustmentsStimulation Time: 2 sec. Inter-trainInterval: 8 sec. Pulses per Burst: 3pulsesInterpulse Interval: 20 msPulses per Session: 600 Session Duration:3.3 min Bursts per Second: 5 burstsAmplitude:0.22-2.08 SMT (≤ 5% drop)	Same
Treatment LevelRange	Standard Treatment0.22 SMT to 2.08 SMTCalibrated linearoutput	Standard Treatment0.22 SMT to 2.08 SMTCalibrated linearoutput	Same
	NeuroBurst Treatment0.22 to 1.9 SMT80-120% MT≤ 5% drop	NeuroBurst Treatment0.22 to 1.9 SMT80-120% MT≤ 5% drop	Same