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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 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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