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The NeuroStar Advanced Therapy system is intended to be used as an adjunct for the treatment of adult patients suffering from Obsessive-Compulsive Disorder (OCD).

Device Description

The NeuroStar Advanced Therapy System is a transcranial magnetic stimulation device. Specifically, it is a computerized, electromechanical device that produces and delivers non-invasive magnetic fields to induce electrical currents targeting specific regions of the cerebral cortex. Transcranial magnetic stimulation (TMS) is a non-invasive technique used to apply brief magnetic pulses to the brain. The pulses are administered by passing high currents through an electromagnetic coil placed adjacent to a patient's scalp. The pulses induce an electric field in the underlying brain tissue. When the induced field is above a certain threshold and is directed in an appropriate orientation relative the brain's neuronal pathway, localized axonal depolarizations are produced, thus activating neurons in the targeted brain region.

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

Mobile Console
System Software
Treatment Chair
Ferromagnetic Treatment Coil
Head Support System
SenStar® Connect Treatment Link & SenStar® Treatment Link
Treatment Pack (for use with the SenStar® Connect Treatment Link)
MT Cap
TrakStar™ Patient Data Management System
D-Tect™ MT Accessory
Beam F3 Treatment Pack
OCD MT Cap

AI/ML Overview

The provided text describes the OCD MT Cap, a single-use wearable device intended to be used as an optional aid during the Obsessive-Compulsive Disorder (OCD) Motor Threshold (MT) determination process for the NeuroStar Advanced Therapy System.

However, the document specifies that no clinical testing was required to support this submission, as the proposed change (addition of the OCD MT Cap) is considered to not raise any different questions regarding safety or effectiveness compared to the predicate device. Therefore, a study proving the device meets specific performance acceptance criteria for diagnostic performance is not detailed in this document.

Instead, the document focuses on non-clinical testing and a technological comparison to establish substantial equivalence to a predicate device.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

Since no clinical performance study was conducted to establish diagnostic accuracy metrics, a table showing acceptance criteria for such metrics cannot be provided. The reported "performance" is primarily related to compliance with recognized standards and usability.

Category	Acceptance Criteria	Reported Device Performance
Non-Clinical Testing
Biocompatibility	Conforms to ISO 10993-1 and FDA Guidance Documents "Use of International Standard ISO 10993-1 'Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process'".	A biocompatibility risk assessment was performed and "revealed no biocompatibility concerns."
Usability	Conforms to FDA Guidance Document: "Applying Human Factors and Usability Engineering to Medical Devices," using IEC 62366-1 as a guide.	"Usability testing was completed" and the results "confirmed that the OCD MT Cap can be successfully used to aid clinicians in the MT determination process to determine the patient's unique MT location."
K231350 (Subject Device) vs. Predicate Device (K212289, K230029) Equivalence
Indications for Use	Same as predicate device (adjunct for the treatment of adult patients suffering from OCD).	No Difference
Intended Use	Same as predicate device (Obsessive Compulsive Disorder).	No Difference
Anatomical Sites	Same as predicate device (Bilateral dorsomedial prefrontal cortex).	No Difference
Target Population	Same as predicate device (Adult patients (ages 22-70) with Obsessive-Compulsive Disorder).	No Difference
Clinical Setting	Same as predicate device (Inpatient and outpatient settings including physician's offices and clinics, hospitals, and general medical/surgical hospitals).	No Difference
Materials	Standard materials compliant with ISO 10993-1, commonly used in consumer and medical devices.	No Difference (Patient-contacting device components use standard materials compliant with ISO 10993-1 that are commonly used in consumer products and medical device applications)
Energy Source	Power console with magnetic coil for delivery for magnetic energy (same as predicate).	No Difference
Electrical Safety & EMC	IEC 60601-1 compliant; IEC 60601-1-2 compliant (same as predicate).	No Difference
Communication with TrakStar	Wireless (Wi-fi) and Ethernet cable (same as predicate).	No Difference
Sterility	No parts required to be sterilized (same as predicate).	No Difference
Coil Type	Ferromagnetic, Iron core, Internal cooling fan (same as predicate).	No Difference
Coil Positioning System	Integrated into Head Support System, Laser-aided coil placement (same as predicate).	No Difference
Treatment Schedule	Weeks 1-5: 1 treatment session per day for 5 days; Week 6: 1 treatment session per day for 4 days; Total of 29 treatment sessions (same as predicate).	No Difference
Device Components	The addition of the OCD MT Cap. (The predicate device did not include the OCD MT Cap.)	Different. The addition of the OCD MT Cap is the subject of this 510(k). Note: The MT Cap, D-Tect™ MT Accessory, and Beam F3 Treatment Pack are not intended to be used as part of the OCD treatment protocol.
%MT Range	25% to 140% MT (same as predicate).	No Difference
Pulses per Second (PPS) Range	For treatment: 1 to 30 PPS; For MT determination: 0.1-0.3 PPS (same as predicate).	No Difference
Induced Electrical field at 2 cm at 1.0 SMT	135 V/m (Nominal) (same as predicate).	No Difference
Pulse Type	Biphasic Sinusoid (same as predicate).	No Difference
Pulse Width	185 µS (Nominal) (same as predicate).	No Difference
Treatment Protocols	Level: 100% foot motor threshold level, Repetition Rate: 20 PPS, Stimulation Time: 2 s, Inter-train Interval: 20 s, Session Duration: As low as 18.3 min, Pulses per Session: 2000, Sessions Per Week: 5 for Weeks 1-5 and 4 for Week 6 (same as predicate).	No Difference
Treatment Level Range	0.22 to 2.08 SMT, Calibrated linear output (same as predicate).	No Difference
Stimulation Time Pulse Train Duration Range	1 PPS: 1 to 600 s; > 1 PPS: 1 to 20 s (same as predicate).	No Difference
Inter-train Interval Range	1 PPS: 0 to 600 s; > 1 PPS: 10 to 60 s (same as predicate).	No Difference
Pulse per Treatment Session	Nominal: 2000; Maximum: 5000 (same as predicate).	No Difference

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

Not applicable. The document explicitly states: "There is no clinical testing required to support this submission." The testing described is non-clinical (biocompatibility, usability) and a technological comparison.

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

Not applicable. No clinical test set requiring expert ground truth was used.

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

Not applicable. No clinical test set requiring adjudication was used.

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:

Not applicable. The OCD MT Cap is an aid for a physical procedure (MT determination), not an AI diagnostic tool used by human readers. No MRMC study was performed.

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

Not applicable. The OCD MT Cap is described as a "single-use wearable device that is intended to be used as an optional aid during the OCD Motor Threshold (MT) determination process." It is a tool to facilitate a human clinician's action, not a standalone algorithm.

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

Not applicable for clinical performance. For the usability testing, the "ground truth" would be the successful aid to clinicians in determining the patient's unique MT location, as confirmed by the usability study results. However, the exact methodology for establishing this success (e.g., expert observation, user feedback metrics) is not detailed.

8. The sample size for the training set:

Not applicable. No machine learning algorithm or AI component requiring a "training set" is described for the OCD MT Cap.

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

Not applicable. No training set was used.

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