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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 (H Coil)
   c) Cap

The provided text is a 510(k) summary for the BrainsWay Deep TMS™ System, seeking to enable modifications to the device labeling based on clinical data. It is important to note that this document does not describe an AI medical device that has acceptance criteria based on diagnostic performance metrics (e.g., sensitivity, specificity, AUC) and a study proving those criteria were met via a test set adjudicated by experts. Instead, this document details a study for a therapeutic device (Transcranial Magnetic Stimulation System) and focuses on clinical outcomes (remission and response rates for Major Depressive Disorder (MDD)).

Therefore, I cannot fulfill all parts of your request as it pertains to an AI medical device's performance study. However, I can extract the relevant information about the clinical studies conducted for the BrainsWay Deep TMS™ System's expanded indication for use.

Here's an analysis based on the provided text, adapted to the context of a therapeutic device rather than a diagnostic AI:

Acceptance Criteria and Study for BrainsWay Deep TMS™ System

This 510(k) submission primarily focuses on expanding the indicated adult population for the BrainsWay Deep TMS™ System to include adult subjects >22 and <86 years of age suffering from MDD, who failed to achieve satisfactory improvement from previous antidepressant medication treatment. The "acceptance criteria" here are not diagnostic performance metrics, but rather clinical efficacy outcomes that demonstrate safety and effectiveness in the expanded patient population, comparable or superior to previously cleared indications and/or standard of care.

1. Table of Acceptance Criteria and Reported Device Performance

As this is a therapeutic device, the "acceptance criteria" are implied to be clinically meaningful improvements in depression symptoms (remission and response rates) and safety comparable to previous findings. The document measures performance against its own previous studies (MDD Multicenter Study) and sham treatment.

2. Sample Sizes and Data Provenance for Test Set (Clinical Studies)

• Kaster 2018 Study (Double-blind, Randomized, Sham-controlled Trial):
  • Total Sample Size: 52 participants
  • Active Deep TMS Treatment Group: 25 participants
  • Sham Deep TMS Treatment Group: 27 participants
  • Provenance: Not explicitly stated, but the study is referenced as "Kaster 2018 Study", implying a published clinical trial. The context of a 510(k) submission generally implies prospective clinical trial data.
  • Population: Elderly MDD patient population (> 60 years old).
• Real-World Data (RWD):
  • Total Patient Records: 1,198 patients
  • Source: Electronic health records from 20 sites over the US.
  • Time Span: 2012 to 2022 (10 years).
  • ITT Patient Population Analysis (met eligibility criteria): 152 subjects
  • Population: Elderly MDD patients (>69 years old: mean age 73.6, range 69-86).
  • Provenance: Retrospective, from the US.

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

• This is a clinical efficacy study for a therapeutic device, not an AI diagnostic device. Therefore, the concept of "ground truth" established by experts for a test set (e.g., radiological reads) as would be the case for an AI diagnostic device, does not apply here.
• Clinical outcomes (HDRS-21, CGI-S, PHQ-9 scores) are typically rated by trained clinicians (e.g., psychiatrists, psychologists). The document does not specify the number or qualifications of clinicians involved in assessing these scores for the Kaster 2018 Study or the RWD. It mentions that approximately 50% of RWD patients were treated by providers with >10 years or <10 years of experience, which relates to treatment providers, not necessarily independent assessors for ground truth.

4. Adjudication Method for the Test Set:

• Again, for a therapeutic device efficacy study measuring clinical scales, "adjudication" in the sense of reconciling reviewer disagreements on diagnostic labels is not directly applicable.
• The Kaster 2018 Study was a double-blind, randomized, sham-controlled trial, which is a strong methodology for assessing treatment efficacy, inherently minimizing bias in outcome assessment. Blinding (neither patient nor assessor knows treatment assignment) often serves a similar purpose to prevent bias as adjudication attempts to for diagnostic interpretations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and effect size of human improvement with vs. without AI assistance:

• No, an MRMC study was not done. This document is for a therapeutic device. MRMC studies are typically performed for diagnostic AI tools to evaluate their impact on human reader performance.
• The study does compare the device's effect to a sham treatment and to previously documented performance (MDD Multicenter Study), showing improvement with the active device. However, this is not a human-AI collaboration study.

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

• Not applicable. The BrainsWay Deep TMS™ System is a medical device, a transcranial magnetic stimulation system, that directly delivers therapy, not a diagnostic algorithm. Therefore, there is no "standalone" algorithm performance to evaluate. Its "performance" is its clinical efficacy when administered.

7. The Type of Ground Truth Used:

• The "ground truth" for efficacy was established through clinical outcome measures based on standardized psychiatric rating scales.
  • Remission: HDRS-21 (Hamilton Depression Rating Scale 21-item), PHQ-9 (Patient Health Questionnaire-9).
  • Response: HDRS-21, PHQ-9, CGI-S (Clinical Global Impression – Severity).
• These are based on the assessment of clinical symptoms and patient status by trained clinicians, not pathology, imaging, or direct outcomes data in the sense of a definitive diagnostic gold standard.

8. The Sample Size for the Training Set:

• Not applicable. This device is a hardware therapeutic system, not an AI algorithm that undergoes a training phase with a dataset. The results presented are from clinical trials and real-world data specifically used to support the expanded indications for use, not to "train" the device.

9. How the Ground Truth for the Training Set was Established:

• Not applicable, for the same reasons as #8. There is no training set or corresponding ground truth for this type of device.

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