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The BrainsWay Deep TMS™ System is indicated for the treatment of depressive episodes and for decreasing anxiety symptoms for those who may exhibit comorbid anxiety symptoms in adult patients suffering from Major Depressive Disorder (MDD) and who failed to achieve satisfactory improvement from previous antidepressant medication treatment in the current episode.

Device Description

The BrainsWay Deep TMS™ System enables direct non-invasive activation of deep brain structures. 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 to the brain's neuronal pathways, localized axonal depolarizations are produced, thus activating neurons in the targeted brain structure. The BrainsWay Deep TMS™ System is composed of the following main components: Cart (TMS Neurostimulator, Cooling System, Positioning Device), and Helmet (Aiming Apparatus, Electromagnetic Coil (H7 Coil), Cap).

AI/ML Overview

The provided text from the FDA 510(k) summary does not contain acceptance criteria or a study that directly proves the device meets those specific criteria in the way typically seen for AI/ML devices with quantitative performance metrics.

Instead, the document details a non-inferiority study to demonstrate that a modified version of a device (BrainsWay Deep TMS™ System with H7 Coil) is as safe and effective as a previously cleared predicate device (BrainsWay Deep TMS™ System with H1 Coil). The "acceptance criteria" in this context are implicitly that the new device performs at least as well as the predicate device within a defined non-inferiority margin for key clinical outcomes.

Here's a breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Non-inferiority Limit)	Reported Device Performance (H7 vs H1 Coil)
Upper limit of one-sided 95% CI for the difference in change from baseline in HDRS-21 at 6 weeks is lower than 3 (non-inferiority limit).	Upper limit of one-sided 95% CI was 1.9.
No statistically significant difference in response rates and remission rates at week 6.	Response rates and remission rates at week 6 were not statistically significantly different.
No statistically significant difference in the incidence of adverse events.	No statistically significant difference in the incidence of any adverse events reported.

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

Sample size: 169 subjects total.
- Specific breakdown by H7 and H1 coil groups is not explicitly stated, but the study was a "Randomized Controlled Trial," implying subjects were divided between these two groups.
Data provenance: Prospective, Multicenter. Country of origin not specified, but the study was titled "Multicenter H7 vs H1 Study."

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

The "ground truth" in this study relates to clinical outcomes over time (e.g., changes in HDRS-21 scores). These scores are typically assessed by trained clinicians, often psychiatrists or psychologists, but the exact number of experts or their specific qualifications for this study are not detailed in the provided text. Scores like HDRS-21 are standardized clinical assessments, not typically "established" by multiple experts for each patient like in imaging adjudication.

4. Adjudication method for the test set

Not explicitly stated. Clinical rating scales like HDRS-21 are usually administered by trained raters, potentially with inter-rater reliability checks, but a formal adjudication method like "2+1" or "3+1" is not mentioned as it would be for diagnostic imaging studies.

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, this was not an MRMC comparative effectiveness study involving human readers with or without AI assistance. It was a clinical trial comparing two different device configurations (H7 coil vs. H1 coil) for direct patient treatment. The device itself is a treatment system, not a diagnostic AI tool. Therefore, an effect size of human reader improvement with AI assistance is not applicable.

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

Not applicable. The device is a deep transcranial magnetic stimulation (TMS) system for treating Major Depressive Disorder, not an algorithm or AI system used for diagnosis or image analysis in a standalone capacity.

7. The type of ground truth used

The ground truth used was clinical outcome data from patient assessments, specifically changes in the Hamilton Depression Rating Scale (HDRS-21) and Hamilton Anxiety Rating Scale (HARS) scores, as well as response and remission rates. These are standard measures of treatment efficacy in psychiatry.

8. The sample size for the training set

Not applicable. This device is a medical device for treatment, not an AI/ML algorithm that requires a "training set" in the conventional sense. The "study" described (CTP-0002-00) is a clinical trial to demonstrate safety and effectiveness for regulatory approval.

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

Not applicable for the same reason as point 8.

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K Number

K203616

Device Name

Brainsway Deep (DTMS) System

Manufacturer

Brainsway Ltd.

Date Cleared

2021-04-16

(127 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K183303,K200957

Intended Use

The Brainsway Deep Transcranial Magnetic Stimulation System is indicated to be used as an aid in short-term smoking cessation for adults.

Device Description

The Brainsway Deep TMS System enables direct non-invasive activation of deep brain structures. 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 pathways, localized axonal depolarizations are produced, thus activating neurons in the targeted brain structure.

The Brainsway Deep TMS System is composed of the following main components:

Cart
a) TMS Neurostimulator
b) Cooling System
c) Positioning Device
Helmet
a) Aiming Apparatus (i.e., ruler/grid)
b) Electromagnetic Coil (H4-Coil)
c) Cap

AI/ML Overview

Based on the provided text, the device in question is the Brainsway Deep TMS System, indicated as an aid in short-term smoking cessation for adults. The document outlines a 510(k) submission, classifying it as a Class II medical device.

Crucially, the provided document explicitly states under the "Clinical Performance Data" section: "Not Applicable." This indicates that no direct clinical efficacy or performance study of the device itself (i.e., algorithm only or human-in-the-loop performance with the device) was conducted or provided for this specific 510(k) submission for the Brainsway Deep TMS System for smoking cessation.

Instead, the submission focuses on demonstrating substantial equivalence to previously cleared predicate devices by Brainsway Ltd., specifically:

Main Predicate (K200957): Brainsway Deep TMS System for smoking cessation.
Reference Predicate (K183303): Brainsway Deep TMS System for OCD (used to demonstrate equivalence of device modifications like the new stimulator).

The acceptance criteria and performance data provided are primarily non-clinical (bench) performance data showing that the modified Brainsway Deep TMS System performs similarly to already cleared versions. The "study that proves the device meets the acceptance criteria" in this context is the bench testing and compliance with recognized standards to demonstrate that the modifications made do not raise new safety or effectiveness concerns compared to the predicate devices.

Therefore, many of the requested details about acceptance criteria, test set sample size, expert ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth for training/test sets are not applicable or not provided in this specific 510(k) summary, as the clearance relies on substantial equivalence based on technical and performance similarities to existing cleared devices, rather than new clinical efficacy demonstrations.

Given this, I will answer the questions based on the information available in the document, highlighting what is and is not present.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a substantial equivalence submission based on non-clinical performance and a pre-existing indication, the "acceptance criteria" are not framed as specific clinical performance metrics (e.g., sensitivity, specificity for a diagnostic device) but rather as successful demonstration of technical equivalence and safety.

Acceptance Criteria Category	Reported Device Performance
Non-Clinical (Bench) Performance
Output Waveform	Demonstrated "substantially equivalent" to the previously cleared Brainsway DTMS System (K200957) through performance testing.
Electrical Field Spatial Distribution	Demonstrated "substantially equivalent" to the previously cleared Brainsway DTMS System (K200957) through performance testing.
Magnetic Field Strength Gradient	Demonstrated "substantially equivalent" to the previously cleared Brainsway DTMS System (K200957) through performance testing.
Electrical Safety	Compliance with IEC 60601-1 standard. Results of tests demonstrated substantial equivalence.
Mechanical Safety	Compliance with IEC 60601-1 standard. Results of tests demonstrated substantial equivalence.
Electromagnetic Compatibility	Compliance with IEC 60601-1-2 standard. Results of tests demonstrated substantial equivalence.
Software Validation	Compliance with FDA guidelines for software validation and IEC 62304 standard requirements. The new stimulator software has been validated to ensure proper performance.
Biocompatibility	Materials are biocompatible.
Functional Equivalence
Intended Use/Indications for Use	Same as the main predicate device (Brainsway Deep TMS System cleared in K200957) for aid in short-term smoking cessation for adults.
Mechanism of Action	Similar mechanism of action (electromechanical instrument producing pulsed magnetic fields to induce electrical currents in targeted brain regions for non-invasive stimulation of cortical neurons).
System Components	Basic components are similar to cleared predicate devices. Minor modifications (new Brainsway stimulator, minor cart/cooling system/coil wire/helmet changes) introduced, but already present in reference predicate (K183303).
Safety Features	Introduces similar safety features and complies with the same relevant consensus standards as predicate devices. Potential hazards from modifications were mitigated through performance testing.
Performance Parameters	Treatment parameters (Magnetic Field Intensity, Frequency, Train duration, Inter-train interval, Number of trains, Magnetic Pulses per Session, Tx Session Duration, Session frequency) are identical to the main predicate (K200957).
Environmental Parameters	Coil's Operating Temperature, Storage Temperature, Atmospheric Pressure Range, and Relative Humidity Range are within the same or comparable bounds as the predicate devices.

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

Sample Size for Test Set: Not applicable / Not specified. The data provided focuses on non-clinical bench testing of the modified device's components and system performance against engineering and safety standards, rather than clinical performance on a patient test set.
Data Provenance: The document does not specify the country of origin for the non-clinical bench test data. It is inherently prospective in the sense that new tests were performed on the modified device, but these are engineering tests, not clinical data from patients.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. As indicated in point 2, there was no clinical test set requiring expert ground truth for patient outcomes or conditions. The "ground truth" for the non-clinical tests would be the established engineering and safety standards (e.g., IEC standards, FDA guidelines for software validation).

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

Not applicable. No clinical test set requiring adjudication was performed or reported in this 510(k) summary.