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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: Cart (TMS Neurostimulator, Cooling System, Positioning Device), and Helmet (Aiming Apparatus, Electromagnetic Coil (H7 Coil), Cap).

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

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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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 indicated to be used as an aid in short-term smoking cessation for adults.

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 scap. 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 FDA cleared Brainsway Deep TMS System is composed of the following main components:

• 1. Electromagnetic Coil
• 2. TMS Neurostimulator
• 3. Cooling System
• 4. Positioning System and Helmet
• 5. Cart

Here's an analysis of the acceptance criteria and study detailed in the provided text:

Acceptance Criteria and Device Performance

The acceptance criteria for the Brainsway Deep TMS System (with HADD-coil) for short-term smoking cessation were primarily based on the statistical significance and clinical meaningfulness of the 4-week Continuous Quit Rate (CQR), supported by secondary endpoints.

Study Details Proving Acceptance Criteria

1. Sample size used for the test set and the data provenance:

   • Test Set Sample Size: N=262 (ITT-Safety population), with 123 subjects in the DTMS arm and 139 subjects in the sham arm.
   • Data Provenance: The study was a "prospective, double blind, randomized, sham controlled, multi-center trial." No specific countries of origin for the data are explicitly stated, but multi-center typically implies multiple sites, which could be in one or more countries. It is a prospective clinical trial.

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

   • The document does not explicitly state the "ground truth" establishment by independent experts for the smoking cessation outcomes. The ground truth for effectiveness (smoking cessation) was determined by objective measures like Continuous Quit Rate (CQR) based on participant self-reporting and likely biochemical verification (though not explicitly stated for this 510(k) summary, it's common in smoking cessation trials). The study was clinically managed, but the role of external experts in adjudicating individual cases of "quit" status is not detailed.

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

   • The document does not describe an adjudication method for the test set outcomes (i.e., whether participants met the smoking cessation criteria). The outcomes appear to be derived from direct data collection (e.g., self-reported smoking diary, likely backed by CO-oximetry or similar biochemical tests, though not mentioned in this excerpt) rather than subjective expert interpretation requiring adjudication.

4. 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. This device is a treatment device (Transcranial Magnetic Stimulation), not an AI diagnostic or assistance tool that would involve human readers interpreting cases.

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

   • This question is not applicable. The Brainsway Deep TMS System is a medical device for treatment, not an algorithm, and it is designed for use by a human operator (clinician) to administer the therapy. Its performance is as a therapeutic device, not an AI or algorithm.

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

   • The ground truth for device efficacy was outcomes data directly from the clinical trial, specifically the 4-week Continuous Quit Rate (CQR) for smoking cessation, along with other self-reported and indirect measures of smoking behavior (e.g., number of cigarettes per day).

7. The sample size for the training set:

   • This question is not applicable. This is a medical device for treatment, not an AI or machine learning model that requires a "training set." The clinical trial data (N=262) served as the validation for its efficacy for the stated indication.

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

   • This question is not applicable as there is no "training set" in the context of this traditional medical device validation.

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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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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 (DTMS) System is intended for the treatment of depressive episodes in patients suffering from MDD. 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 (DTMS) System is composed of the following main components: An Electromagnetic Coil (H1 Coil), A TMS Neurostimulator, A Cooling System, A Positioning Device, A cart.

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state pre-defined acceptance criteria for the clinical study. Instead, it describes observed effectiveness and safety outcomes that were deemed sufficient for demonstrating the device's performance. The "acceptance criteria" are implied by the statistically significant improvements shown.

Non-Clinical Performance Data: The device also met several non-clinical performance criteria, including output waveform and electric field spatial distribution, magnetic field strength gradient, and cooling system functionality (e.g., consistent temperature during continuous operation >180 days).

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

• Test Set (Clinical Study):
  • ITT analysis set: n=229 (108 DTMS, 121 Sham)
  • mITT analysis set: n=212 (101 DTMS, 111 Sham)
  • PP analysis set (most relevant for efficacy): n=181 (89 DTMS, 92 Sham)
• Data Provenance: Prospective, double-blind, randomized, controlled, multi-center trial conducted at 20 study sites in the United States (13 sites), Israel (4 sites), Germany (2 sites), and Canada (1 site).

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

The document does not specify the number of experts or their qualifications for establishing the "ground truth" for the test set. However, for Major Depressive Disorder (MDD), the "ground truth" for diagnosis and severity is typically established by trained psychiatrists or other mental health professionals using standardized diagnostic criteria (e.g., DSM-IV, DSM-5) and validated rating scales (e.g., HDRS-21, CGI-S, BDI). The study used the HDRS-21 score (Hamilton Depression Rating Scale) as a primary outcome measure, which is administered and scored by trained clinicians.

4. Adjudication Method for the Test Set

The document describes the study as "double blind, randomized, controlled," which implies that clinicians assessing patient outcomes were blinded to the treatment arm (DTMS or Sham). However, it does not explicitly detail any specific adjudication method (e.g., 2+1, 3+1 for resolving discrepancies in assessments).

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 and AI assistance. This study evaluated the effectiveness of a medical device (Deep TMS System) in treating Major Depressive Disorder, comparing it to a sham treatment, not the performance of human readers with or without AI.

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

No, this was a clinical study evaluating a medical device treatment, not an AI algorithm. The device itself is a treatment modality, not a diagnostic or interpretive tool that would have a standalone algorithm performance.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The ground truth for the effectiveness of the Brainsway Deep TMS System was established based on clinical outcomes data from a randomized, controlled trial. Key metrics used included:

• Hamilton Depression Rating Scale (HDRS-21) scores (change from baseline, response rates, remission rates).
• Clinical Global Impression – Severity (CGI-S) and Improvement (CGI-I) scores.
• Patient Global Impression (PGI) scores.
• Global Assessment of Functioning (GAF) scores.
• Cognitive tests (MMSE, BSRT, AMI-SF) to assess cognitive effects.
• Adverse event reporting for safety.

These are all standard outcome measures in psychiatric clinical trials, typically assessed by trained clinicians.

8. The Sample Size for the Training Set

The document does not describe a "training set" in the context of an AI algorithm. This study is a clinical trial evaluating a medical device, not a machine learning model. Therefore, there is no separate training set as understood in AI/ML contexts. The clinical study itself served as the primary validation for the device's efficacy and safety.

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

As explained above, there was no "training set" for an AI algorithm. The clinical study served as the primary evidence. The ground truth for this study (diagnosis of MDD, severity, response, remission, etc.) was established by clinicians using standard diagnostic criteria and validated rating scales within the context of a prospective clinical trial.

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