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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.

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