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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.

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.

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