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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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The BrainsWay Deep TMS System is indicated for the treatment of depressive episodes in adult patients suffering from Major Depressive Disorder who failed to achieve satisfactory improvement from previous anti-depressant 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 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

Here's a breakdown of the acceptance criteria and study information for the BrainsWay Deep TMS System with iTBS Protocol, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this 510(k) submission are established through demonstrating non-inferiority of the new iTBS protocol compared to an already FDA-cleared High Frequency (HF) protocol for the same device. The primary endpoint for non-inferiority was the change in HDRS-21 score.

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

• Test Set Sample Size: 146 subjects
  • 66 subjects received iTBS stimulation protocol.
  • 80 subjects received HF stimulation protocol.
• Data Provenance: Not explicitly stated as retrospective or prospective, nor country of origin. However, given it's a clinical study for FDA clearance, it's highly likely to be a prospective multi-center study, though the specific locations are not provided in this summary. The mention of "multicenter MDD study" for age eligibility criteria might hint at a multi-site study.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This particular study does not involve establishing ground truth through expert review of specific data like images. Instead, the "ground truth" for the effectiveness of the treatment is based on patient-reported outcomes and clinician-administered scales (HDRS-21, CGI-S), which inherently involve expert clinicians in their administration and interpretation during the study.

4. Adjudication Method

Not applicable in the typical sense of radiological or pathological adjudication. The primary and secondary endpoints are based on standardized clinical assessment scales (HDRS-21, CGI-S) administered by qualified clinical personnel as part of the study protocol.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This study is a clinical trial comparing two different stimulation protocols (iTBS vs. HF) on human patients for Major Depressive Disorder (MDD), not a reader study involving interpretation of cases by multiple human readers.

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

This is a medical device for treatment, not an AI/algorithm for diagnosis or analysis where standalone performance would typically be evaluated. The "performance" being assessed is the clinical effectiveness of the device (iTBS protocol) in treating MDD. Therefore, a standalone algorithm-only performance study is not applicable.

7. The Type of Ground Truth Used

The ground truth used for determining the effectiveness of the device in this clinical study is:

• Clinical Outcomes Data: Specifically, changes in patient depression levels as measured by established clinical rating scales (HDRS-21 and CGI-S scores) from baseline to follow-up, along with derived response and remission rates.

8. The Sample Size for the Training Set

Not applicable. This document describes a clinical study to evaluate the effectiveness of a medical device's protocol, not a machine learning model that requires a training set.

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

Not applicable, as there is no training set mentioned or implied for a machine learning algorithm. The "training" for this device refers to the clinical application of the stimulation protocol in the context of treating patients.

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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 proposed device is a modification to the Brainsway Deep TMS System that was cleared under DEN170078. Brainsway has implemented minor changes to the helmet configuration, improved the user interface, modified the measurement method, and made other minor component changes. None of these changes alter the technical specifications for the device, which maintains the same voltage and current, same frequencies, and same electrical mains compatibility. The same technological features have previously been cleared by FDA for use in major depressive disorder in K173540.

Consistent with the predicate and reference device, the proposed 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 provided text describes modifications to the Brainsway Deep TMS System and asserts its substantial equivalence to a previously cleared predicate device. It does not provide detailed acceptance criteria or results of a clinical study to prove the device meets specific performance criteria. Instead, it focuses on demonstrating that the modifications do not introduce new questions of safety or effectiveness compared to the predicate device.

Therefore, many of the requested details about acceptance criteria, clinical study methodology, and ground truth establishment cannot be found in the provided document. The document primarily confirms that the modified device functions as intended and meets the same acceptance criteria as the predicate and reference devices, based on software verification, electrical safety, EMC, and bench performance testing.

Here's an analysis based on the provided text, highlighting what is available and what is not:

Acceptance Criteria and Device Performance

The document does not provide a specific table of acceptance criteria with numerical targets and corresponding reported device performance for a clinical study proving efficacy or diagnostic accuracy. Instead, it states:

"In all instances, the subject device functions as intended and meets all the same acceptance criteria as the predicate and reference device."

This implies that the acceptance criteria are generally related to the proper functioning of the device, electrical safety, electromagnetic compatibility, and bench performance, rather than clinical efficacy metrics. For an efficacy study demonstrating treatment outcomes for OCD, such details would typically be found in a separate clinical study report.

The "Indications for Use" section states: "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." This is the clinical claim, but the document doesn't present a study proving the device meets this claim with performance metrics. It relies on the substantial equivalence to the predicate device, which presumably had clinical data supporting its efficacy for this indication.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not provided in the document. The document describes "software verification and validation," "electrical safety," "EMC," and "bench performance testing." These are engineering and performance validation tests, not typically clinical studies with "test sets" of patient data in the sense of a machine learning model.
• If a prior clinical study for the predicate device existed for OCD treatment, that information is not detailed here.

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

• Not applicable / Not provided. Since this document describes engineering and bench testing, rather than a clinical trial or an AI/diagnostic device study requiring expert ground truth establishment for a patient dataset, this information is not relevant to the described testing.

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

• Not applicable / Not provided. See explanation for #3.

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 document describes a medical device (Transcranial Magnetic Stimulation System) for treatment, not an AI-assisted diagnostic or imaging device used by "human readers." Therefore, an MRMC study is not relevant to the described device.

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

• Stand-alone performance was indirectly evaluated through bench testing and compliance. The device itself is a "human-in-the-loop" device as it delivers treatment under medical supervision. The "standalone" performance here refers to the device's technical specifications and electrical/mechanical performance, which was assessed through the described tests (software, electrical safety, EMC, bench performance). The document states: "In all instances, the subject device functions as intended and meets all the same acceptance criteria as the predicate and reference device." This implies standalone technical performance testing.

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

• For the technical and safety testing described (software, electrical safety, EMC, bench performance):
  • Ground Truth: Engineering specifications, regulatory standards (e.g., IEC 60601-1, IEC 60601-1-2), and comparison to the performance of the predicate and reference devices. The "ground truth" is that the device should operate within specified technical parameters and safety limits.
• For the clinical efficacy of the device for OCD treatment (which is its intended use):
  • The document implies that the predicate device (DEN170078) already established clinical efficacy for OCD. This specific document for K183303 relies on "substantial equivalence" and does not describe a new clinical trial for efficacy. If such a trial existed for the predicate, the ground truth would likely have been clinical outcome measures for OCD (e.g., Yale-Brown Obsessive Compulsive Scale (YBOCS) scores or similar psychiatric outcome scales).

8. The sample size for the training set

• Not applicable / Not provided. The Brainsway Deep TMS System is a Transcranial Magnetic Stimulation device, not an AI/machine learning algorithm that requires a "training set" of data in the common sense. Its "training" is its engineering design and manufacturing.

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

• Not applicable / Not provided. As explained in #8, there is no "training set" in the context of an AI model for this device.

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