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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 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 (H4-Coil)
   c) Cap

Based on the provided text, the device in question is the Brainsway Deep TMS System, indicated as an aid in short-term smoking cessation for adults. The document outlines a 510(k) submission, classifying it as a Class II medical device.

Crucially, the provided document explicitly states under the "Clinical Performance Data" section: "Not Applicable." This indicates that no direct clinical efficacy or performance study of the device itself (i.e., algorithm only or human-in-the-loop performance with the device) was conducted or provided for this specific 510(k) submission for the Brainsway Deep TMS System for smoking cessation.

Instead, the submission focuses on demonstrating substantial equivalence to previously cleared predicate devices by Brainsway Ltd., specifically:

• Main Predicate (K200957): Brainsway Deep TMS System for smoking cessation.
• Reference Predicate (K183303): Brainsway Deep TMS System for OCD (used to demonstrate equivalence of device modifications like the new stimulator).

The acceptance criteria and performance data provided are primarily non-clinical (bench) performance data showing that the modified Brainsway Deep TMS System performs similarly to already cleared versions. The "study that proves the device meets the acceptance criteria" in this context is the bench testing and compliance with recognized standards to demonstrate that the modifications made do not raise new safety or effectiveness concerns compared to the predicate devices.

Therefore, many of the requested details about acceptance criteria, test set sample size, expert ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth for training/test sets are not applicable or not provided in this specific 510(k) summary, as the clearance relies on substantial equivalence based on technical and performance similarities to existing cleared devices, rather than new clinical efficacy demonstrations.

Given this, I will answer the questions based on the information available in the document, highlighting what is and is not present.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a substantial equivalence submission based on non-clinical performance and a pre-existing indication, the "acceptance criteria" are not framed as specific clinical performance metrics (e.g., sensitivity, specificity for a diagnostic device) but rather as successful demonstration of technical equivalence and safety.

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

• Sample Size for Test Set: Not applicable / Not specified. The data provided focuses on non-clinical bench testing of the modified device's components and system performance against engineering and safety standards, rather than clinical performance on a patient test set.
• Data Provenance: The document does not specify the country of origin for the non-clinical bench test data. It is inherently prospective in the sense that new tests were performed on the modified device, but these are engineering tests, not clinical data from patients.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable. As indicated in point 2, there was no clinical test set requiring expert ground truth for patient outcomes or conditions. The "ground truth" for the non-clinical tests would be the established engineering and safety standards (e.g., IEC standards, FDA guidelines for software validation).

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

• Not applicable. No clinical test set requiring adjudication was performed or reported in this 510(k) summary.

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 is a medical device for treatment (Transcranial Magnetic Stimulation), not an AI diagnostic/imaging device. Therefore, a MRMC study for AI assistance to human readers is not relevant and was not performed.

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

• The device (Brainsway Deep TMS System) is a physical medical device. It does not operate as a standalone algorithm in the way a diagnostic AI would. Its performance is evaluated through its physical output (magnetic pulses) and electrical/mechanical characteristics as detailed in the non-clinical tests, and its substantial equivalence to a predicate device. Clinical performance of the therapy using the device relies on the operator (human-in-the-loop) and the patient, but the performance evaluation here is for the device's technical specifications.

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

• For non-clinical performance: The "ground truth" is adherence to established engineering, electrical, mechanical, and software safety standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 62304) and comparison to the output/characteristics of the legally marketed predicate devices.
• For the overall indication (smoking cessation): The acceptability of the indication itself and its efficacy as a therapy stems from the prior clearance of the predicate device (K200957), which would have established this efficacy through clinical trials (though not detailed in this particular 510(k) summary).

8. The sample size for the training set

• Not applicable. This device is not an AI/ML algorithm that requires a "training set" in the conventional sense for learning patterns from data. The "training" in this context would be the design and development processes for the hardware and software, and testing against specifications.

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

• Not applicable. As above, there is no "training set" for an AI/ML algorithm in this context.

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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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