Search Results

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.

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:

• 1. Cart
  • a) TMS Neurostimulator
  • b) Cooling System
  • c) Positioning Device
• 2. Helmet
  • a) Aiming Apparatus (i.e., ruler/grid)
  • b) Electromagnetic Coil (H1-Coil)
  • c) Cap

The provided text describes the 510(k) summary for the BrainsWay Deep TMS System, primarily focusing on its expanded indication for decreasing anxiety symptoms in adult patients with Major Depressive Disorder (MDD). The document does not describe the acceptance criteria and the study that proves the device meets the acceptance criteria (except for performance standards from medical device norms and guidance mentioned on page 5). While it references clinical studies to demonstrate safety and effectiveness for the expanded indication, it doesn't detail the specific statistical acceptance criteria that the device had to meet based on these studies for clearance.

Here's an analysis of the provided information relative to your request:

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

• Acceptance Criteria: The document does not explicitly state quantitative acceptance criteria for clinical performance. It mentions conformance to FDA recognized consensus standards (IEC 60601-1, IEC 60601-1-2, IEC 62304, ISO 10993-5, ISO 10993-10, ISO 14971) for non-clinical testing (Output Waveform, Electrical Field Spatial Distribution, Magnetic Field Strength Gradient Testing, electrical and mechanical safety, EMC, software validation). For clinical performance, the criterion seems to be demonstrating "safety and effectiveness" and "clinically significant decrease in anxiety symptoms" by showing "effect sizes" that are "consistent, robust and similar" to those reported for MDD.

• Reported Device Performance: The document reports "effect sizes" (Cohen's d) from three Randomized Controlled Trials (RCTs) and meta-analyses, specifically related to the reduction of anxiety symptoms measured by the HDRS-21 Anxiety-Somatization Factor score.

  Study / Analysis	Effect Size (Cohen's d)	95% Confidence Limits (Lower, Upper)
  Levkovitz 2015 (Deep TMS vs. Sham)	0.34	(0.009, 0.667)
  Kaster 2018 (Deep TMS vs. Sham)	0.36	(-0.23, 0.95)
  Filipcic 2019 (Deep TMS vs. Medication as SOC)	0.90 (DH1 vs DSOC)	(0.55, 1.26)
  Meta-analysis of three RCTs (Deep TMS vs. Sham/SOC)	0.55 (weighted pooled)	Not specified
  Kezior et al. Meta-analysis (6/11 studies)	1.45 (pooled weighted)	Not specified
  Hung et al. Meta-analysis (8/11 studies)	-1.282 (Hedges' g)	Not specified

  The document highlights that these effect sizes "may be compared to the effect size seen in the Multicenter MDD Study for all MDD subjects using the HDRS-21 score, where an effect size of 0.76... was reported."

2. Sample sizes used for the test set and the data provenance:

• Test Set Description: The "clinical performance data" section indicates that the evidence supporting the expanded indication came from "3 Randomized Controlled Trials (RCTs) and supportive data from meta-analyses from 11 clinical studies (including the 3 RCTs and another 8 open label studies) using the BrainsWay Deep TMS device in 573 patients."
• Sample Sizes per RCT:
  • Levkovitz 2015: DTMS: 89, Sham: 92
  • Kaster 2018: DTMS: 25, Sham: 27
  • Filipcic 2019: DTMS: 65, Medication as SOC: 72
• Data Provenance: The document implies these were clinical trials, which are typically prospective. The location of the studies (country of origin) is not explicitly stated, although the applicant and contact person are based in Israel, suggesting that some of these studies might have been conducted there or internationally. The term "Multicenter MDD Study" could imply international collaboration. The provenance is explicitly listed as a "prospective multicenter randomized controlled trial" for Levkovitz 2015, and "prospective randomized controlled trial" for Kaster 2018.

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

• This information is not provided in the document. Clinical trials of this nature would typically involve medical professionals (e.g., psychiatrists) for patient assessment and diagnosis (which forms the basis for "ground truth" for patient inclusion criteria and outcome measures), but the specific number and qualifications of experts for objective ground truth establishment (e.g., blinded rating panels) are not detailed.

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

• This information is not provided in the document. For clinical outcome measures, some studies use blinded independent raters, but whether an adjudication process was used among multiple raters is not mentioned.

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:

• This is not applicable to this device. The BrainsWay Deep TMS System is a therapeutic device (Repetitive Transcranial Magnetic Stimulation system), not an AI-assisted diagnostic or imaging interpretation tool that would typically involve human "readers" or MRMC studies. The clinical studies focus on direct outcomes from the device's therapeutic application.

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

• This is not applicable to this device. As a therapeutic device, its performance is evaluated based on its clinical effect on patients, not as an algorithm performing a standalone task. The device works with human operators (healthcare professionals) who administer the treatment.

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

• The "ground truth" in these studies is outcomes data based on clinical assessments.
  • Patient Diagnosis: Major Depressive Disorder (MDD) as per DSM-IV criteria, with patients who failed previous antidepressant medication treatment. This implies diagnosis by qualified clinicians.
  • Outcome Measure: Change in HDRS-21 Anxiety-Somatization Factor Score from baseline. The HDRS-21 (Hamilton Depression Rating Scale) is a widely used clinician-administered rating scale. While administered by humans, it yields quantitative data. The "ground truth" for the effectiveness of the treatment is the statistically significant reduction in these symptom scores compared to control groups (Sham or medication as standard of care).

8. The sample size for the training set:

• This information is not applicable as this is not an AI/ML device that requires a distinct "training set" in the traditional sense for algorithm development. The "training" for the device, if any, would refer to the pre-clinical characterization and validation. The clinical studies mentioned are for validation of the device's therapeutic effect.

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

• This is not applicable for the reasons stated above.

In summary, the provided document details the non-clinical performance standards and clinical study results (effect sizes) that support the device's expanded indication. However, it does not provide explicit pre-defined quantitative acceptance criteria for the clinical studies, nor does it address aspects like expert consensus or MRMC studies, which are typically relevant for diagnostic AI/ML devices. The "acceptance" for this device appears to be based on demonstrating statistically and clinically meaningful improvement in anxiety symptoms, which the reported effect sizes aim to prove.

Ask a specific question about this device

The Brainsway Deep Transcranial Magnetic Stimulation System is intended to be used as an adjunct for the treatment of adult patients suffering from Obsessive-Compulsive Disorder.

The Brainsway DTMS System enables direct non-invasive activation of brain structures. 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 DTMS System is composed of the following five main components:

• Electromagnetic Coil (HAC-Coil)
• TMS Neurostimulator
• Cooling System
• Positioning Device
• Personal Head Cap

The provided text describes a clinical study to establish the safety and effectiveness of the Brainsway Deep Transcranial Magnetic Stimulation (DTMS) System for the treatment of Obsessive-Compulsive Disorder (OCD).

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for effectiveness appear to be based on the primary effectiveness endpoint: a statistically significant reduction in Yale-Brown Obsessive Compulsive Scale (YBOCS) scores compared to sham treatment. Additionally, clinically meaningful reductions in OCD severity are highlighted.

The ITT analysis set (N=99) did not achieve statistical significance (p-value: 0.0988) due to a higher reduction in YBOCS in the Sham group (4.1 points) compared to the mITT Sham group (3.3 points), but a clinically meaningful reduction (6.0 points) was still observed in the DTMS group. |
| Secondary Endpoints:

• Response rate (≥30% YBOCS reduction from baseline) at 6 weeks.
• Partial Response rate (≥20% YBOCS reduction from baseline) at 6 weeks.
• Improvement in CGI-I ("Improved" category: moderately improved to very much improved) at 6 weeks.
• Improvement in CGI-S ("Improved" category) at 6 weeks.
• Sustained YBOCS reduction at 10 weeks. | Met (with qualifications):
• Response Rate: DTMS: 38.1% (16/42), Sham: 11.1% (5/45) in mITT.
• Partial Response Rate: DTMS: 54.8% (23/42), Sham: 26.7% (12/45) in mITT.
• CGI-I "Improved": DTMS: 49% (20/41), Sham: 21% (9/43) in mITT.
• CGI-S "Improved": DTMS: 61% (25/41), Sham: 33% (14/43) in mITT.
• YBOCS at 10 Weeks: Adjusted mean YBOCS reduction of 6.5 points (95% CI: [4.3;8.7]) in the DTMS group, indicating stability.

(Note: Formal statistical testing was stopped at the first secondary endpoint, so p-values for other secondary endpoints were unadjusted for multiplicity, but results show favorable trends for DTMS). |
| Safety: Device is safe and tolerable, with adverse events being minor, reversible, and typical for TMS devices, and no significant differences in vital signs, physical/neurological exams, or cognitive status between treatment groups. Absence of serious related adverse events. | Met:

• AEs reported by 73% (DTMS) vs. 69% (Sham).
• Most frequent AE was headache (37.5% DTMS, 35.3% Sham).
• Other pain/discomfort (administration site, jaw, facial, muscle, neck, dizziness) were mild/moderate and resolved.
• No reports of hypoacusis (hearing loss).
• No notable differences in vital signs, physical/neurological exams between groups.
• One SAE reported, assessed as not device-related (suicidal thoughts preceding study). |

2. Sample Size Used for the Test Set and Data Provenance

• Test Set (Clinical Study Population):
  • Total enrolled: 100 subjects.
  • ITT Analysis Set (received at least one treatment): 99 subjects (48 DTMS, 51 Sham).
  • mITT Analysis Set (met eligibility criteria): 94 subjects (47 DTMS, 47 Sham). This was the principal data analysis set for efficacy.
  • Per-Protocol Analysis Set (without major protocol deviations): 93 subjects (46 DTMS, 47 Sham).
• Data Provenance: Prospective, randomized, double-blinded, multi-site, sham-controlled clinical trial. The study was conducted at 11 study sites in the United States (9 sites), Israel (1 site), and Canada (1 site).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

• The ground truth for the effectiveness of the treatment was established through clinical assessments using standardized scales like the YBOCS, Sheehan Disability Scale (SDS), and Clinical Global Impression - Severity (CGI-S) and Improvement (CGI-I).
• These assessments were performed by independent raters. While the exact number of independent raters or their specific qualifications (e.g., years of experience as psychiatrists or psychologists) is not explicitly stated, the study design mentions that "the independent rater" was blinded to the treatment administered. This implies that trained clinical professionals, likely psychiatrists or psychologists, administered these critical rating scales.

4. Adjudication Method for the Test Set

• The study design involved a double-blinded approach where both study personnel (including the operator and independent rater) and study subjects were blinded to whether active or sham treatment was administered.
• The primary and secondary outcome measures (YBOCS, SDS, CGI-S, CGI-I) are standardized clinical scales that are typically administered by trained personnel. There is no explicit mention of an "adjudication method" like 2+1 or 3+1 for discordance between multiple experts for individual case ground truth, as these scales are designed for direct clinical assessment. The "ground truth" here is the patient's symptom severity and improvement as measured by these scales.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

• No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed. This study directly evaluated the effectiveness of a medical device (DTMS system) for treating OCD in patients, not an AI system assisting human readers. Therefore, the concept of "how much human readers improve with AI vs. without AI assistance" is not applicable to this study.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• No, a standalone (algorithm only) performance study was not done. The study evaluated a medical device that is administered to patients by trained operators, with outcomes assessed by independent clinical raters. This is a human-in-the-loop system in the context of patient treatment and assessment, not an AI algorithm acting autonomously.

7. The Type of Ground Truth Used

• The ground truth used for determining treatment effectiveness was based on expert clinical assessments and standardized patient-reported outcomes. Specifically:
  • Yale-Brown Obsessive Compulsive Scale (YBOCS): A clinician-administered scale that measures the severity of OCD symptoms.
  • Sheehan Disability Scale (SDS): A patient-rated scale that assesses functional impairment.
  • Clinical Global Impression - Severity (CGI-S) and Improvement (CGI-I): Clinician-rated scales that measure global severity and improvement of illness.
  • Response/Remission Definitions: Pre-defined thresholds of YBOCS score reduction or absolute score for clinical response and remission.
• For safety, ground truth was assessed through adverse event reporting, vital signs, physical/neurological examinations, and cognitive tests.

8. The Sample Size for the Training Set

• This was a clinical trial evaluating a medical device, not a machine learning model. Therefore, there was no "training set" in the context of machine learning model development. The sample size used for the clinical study (94-99 subjects in the analysis sets) was for direct evaluation of the device's efficacy and safety.

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

• As there was no machine learning "training set," this question is not applicable. The clinical trial directly provided the data (including outcome measures like YBOCS scores) used to assess the device's performance.

Ask a specific question about this device