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The Generation 2.0 Monarch external Trigeminal Nerve Stimulation (eTNS) System® ("Monarch Gen 2") is indicated for treatment of pediatric Attention Deficit Hyperactivity Disorder (ADHD) as a monotherapy in patients ages 7 through 12 years old who are not currently taking prescription ADHD medications. The device is used for patient by prescription only and is intended to be used in the home under the supervision of a caregiver during periods of sleep.

The Monarch Gen 2 eTNS System is a non-invasive device that uses electrical signals to therapeutically stimulate the Trigeminal nerve. The primary components of the device are:

• . The Monarch® Gen 2 external pulse generator, which controls the electrical stimulation, and
• The Monarch® NS-2 external (cutaneous) electrical patches, which are single-use disposable patches worn on the forehead (Figure 3).

The provided text describes the Generation 2.0 Monarch external Trigeminal Nerve Stimulation (eTNS) System for treating pediatric Attention Deficit Hyperactivity Disorder (ADHD) and compares it to its predicate device, the first-generation Monarch eTNS System. However, it does not explicitly state acceptance criteria in a table format and does not detail a specific study proving the device meets these criteria in the way requested. Instead, it focuses on demonstrating substantial equivalence to the predicate device through technological comparison and performance data from internal bench tests and external lab testing, along with a reference to the clinical trials that supported the clearance of the first-generation device.

Based on the provided information, here's an attempt to structure the answer, acknowledging the limitations in fully addressing all aspects of the request due to the nature of the text:

1. A table of acceptance criteria and the reported device performance

The document does not provide a formal table of "acceptance criteria" and "reported device performance" for the Generation 2.0 Monarch eTNS System in the context of clinical efficacy for ADHD. Instead, it relies on demonstrating substantial equivalence to its predicate device, which had previous regulatory clearance based on clinical trials. The performance data presented for the Generation 2.0 device primarily relate to safety and technical compliance.

2. Sample size used for the test set and the data provenance

For the Generation 2.0 Monarch eTNS System:

• Test set sample size: Not specified as a clinical test set. The performance data provided are from internal bench tests and external lab testing (e.g., electrical safety, EMC, battery testing, biocompatibility). These tests do not typically involve human subjects or "test sets" in the clinical sense.
• Data provenance: Not specified, but generally from internal company testing and external independent testing laboratories. The document implies these are retrospective for the purpose of demonstrating equivalence, as they are not new clinical trials for the Gen 2 device.

For the first-generation Monarch eTNS System (predicate device) (which the efficacy claims of Gen 2 lean on):

• Test set sample size: Two clinical trials.
  • Trial 1: 24 subjects (ages 7-14)
  • Trial 2: 62 subjects (ages 8-12)
• Data provenance: Clinical trials. The document does not specify the country of origin, nor whether they were retrospective or prospective, but clinical trials supporting device clearance are typically prospective.

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 for either the Generation 2.0 device's testing or the clinical trials of the first-generation predicate device. Clinical trials for ADHD would typically involve assessments by qualified clinicians (e.g., child psychiatrists, developmental pediatricians) using standardized diagnostic and symptom rating scales, but the text does not detail the specific number or qualifications of experts involved in establishing ground truth (e.g., ADHD diagnosis, symptom improvement assessments).

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

This information is not provided. Clinical trials for ADHD often involve multiple raters for symptom scales, with potential for adjudication in cases of disagreement, but the document does not elaborate on these methodologies for the predicate device's 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

An MRMC comparative effectiveness study is not applicable to this device. This type of study usually pertains to diagnostic imaging or AI-assisted diagnostic tools where human readers interpret medical images or data. The Monarch eTNS System is a therapeutic device for ADHD. The document mentions clinical trials showing a "statistically significant outcome on the primary endpoint" for the predicate device, which implies efficacy, but not an MRMC study comparing human performance with and without AI assistance.

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

This concept is not applicable to this device. The Monarch eTNS System is a therapeutic device applied by a caregiver, not an algorithm that performs a task independently or as part of a diagnostic workflow.

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

For the Generation 2.0 Monarch eTNS System:

• The "ground truth" for its performance data is compliance with recognized standards (IEC 60601-x for electrical safety, EMC, home environment, nerve stimulation) and engineering specifications (battery life, output current).

For the first-generation Monarch eTNS System (predicate device):

• The ground truth for effectiveness was based on clinical outcomes data from two trials, demonstrating "statistically significant outcome on the primary endpoint." This would typically involve standardized clinical assessment tools for ADHD symptoms and functional impairment.

8. The sample size for the training set

This information is not provided. This term is usually relevant for machine learning algorithms. For regulatory clearance of a medical device, the focus is on verification and validation studies (like bench testing) and clinical trials (for the predicate device's efficacy), not typically on "training sets" in the AI sense.

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

As the concept of a "training set" in the AI sense is not applicable here, this information is not provided.

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The Monarch external Trigeminal Nerve Stimulation (eTNS) System is indicated for treatment of pediatric Attention Deficit Hyperactivity Disorder as a monotherapy in patients ages 7 through 12 years old who are not currently taking prescription ADHD medications. The device is used for patient treatment by prescription only and is intended to be used in the home under the supervision of a caregiver during periods of sleep.

The Monarch external Trigeminal Nerve Stimulation (eTNS) System is a non-invasive device that uses electrical signals to therapeutically stimulate the Trigeminal nerve. The primary components of the device are:

• The Monarch external pulse generator
• The Monarch NS-2 external (cutaneous) electrical patches, which are single use disposable patches worn on the forehead.

The device has two primary components A) an external pulse generator approximately the size of a cell phone, and B) the non-invasive electrical patch that patients apply to their forehead to receive therapy.

The Monarch eTNS System underwent two clinical studies to establish its effectiveness and safety.

1. Acceptance Criteria and Reported Device Performance

The primary acceptance criteria for effectiveness were based on the change in ADHD-IV Rating Scale (ADHD-RS) scores.

2. Sample Size and Data Provenance

Study 1 (eTNS-ADHD01):

• Test Set Sample Size: 24 subjects initiated treatment (22 completed at least to Week 4 for analysis).
• Data Provenance: Not explicitly stated, but clinical studies for FDA De Novo requests typically involve US-based participants. The study was open-label.

Study 2 (eTNS-ADHD02):

• Test Set Sample Size: 62 subjects enrolled and randomized (32 to active, 30 to sham). 59 subjects completed the 4-week double-blind treatment period (31 in active, 28 in sham). A subset of patients (18 initially) continued in an open-label extension for long-term data.
• Data Provenance: Not explicitly stated, but the demographics showing a diverse and representative US treatment population suggest a US origin. The study was prospective, randomized, and double-blind, sham-controlled.

3. Number of Experts and Qualifications for Ground Truth

The ground truth for the effectiveness endpoints (ADHD-RS and CGI-I) was based on clinical assessments by qualified personnel.

• Study 1: The pre-specified primary outcome measure was the investigator-completed ADHD-RS. This implies a trained clinical investigator assessed the ADHD-RS. Specific qualifications (e.g., number of years of experience, specific specialty) are not detailed in the provided text, beyond being "investigators."
• Study 2: The primary endpoint was also the ADHD-IV RS, and the CGI-I was a secondary endpoint. It is implied these were also assessed by clinical investigators. Again, specific qualifications of these experts are not explicitly detailed.

4. Adjudication Method for the Test Set

The information provided does not explicitly detail an adjudication method (like 2+1, 3+1, or none) for establishing ground truth for the test sets in either study. The ADHD-RS is an investigator-rated scale, implying a single assessment per participant rather than a consensus approach involving multiple independent raters with subsequent adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was performed or described. The studies conducted were clinical trials evaluating the device's therapeutic effect on patients, not studies comparing human reader performance with or without AI assistance in diagnostics. Therefore, an effect size of how much human readers improve with AI vs without AI assistance is not applicable here.

6. Standalone Performance (Algorithm Only)

The Monarch eTNS System is a medical device for therapy delivery, not a diagnostic algorithm. Therefore, a standalone performance study of an algorithm without human-in-the-loop performance is not applicable to this device. Its performance is measured by its therapeutic effect on patients, as demonstrated in clinical trials.

7. Type of Ground Truth Used

The ground truth for the effectiveness of the Monarch eTNS System was based on clinical assessment scales and their interpretation by clinical investigators/experts.

• Study 1 & 2: The primary effectiveness measure was the ADHD-IV Rating Scale (ADHD-RS) an assessment tool completed by clinicians to quantify ADHD symptoms.
• Study 1 & 2: Secondary effectiveness measures included the CGI-Improvement Scale (CGI-I), another clinician-rated scale to assess global improvement.
• Safety: Ground truth for safety was based on the reporting of adverse events by participants and/or caregivers, and their assessment by study investigators.

8. Sample Size for the Training Set

The provided document describes clinical trials (eTNS-ADHD01 and eTNS-ADHD02) which are typically used for validation of the device's safety and effectiveness. It does not mention a separate "training set" for an algorithm, as the Monarch eTNS system is a neuromodulation device, not an AI or machine learning diagnostic tool that requires a training set in the conventional sense. The studies serve as the evidence base for its clinical utility.

9. How Ground Truth for the Training Set Was Established

As mentioned above, the concept of a "training set" for an algorithm is not applicable to this device. The clinical trials served as the primary evidence collection for evaluating the device's performance, with ground truth established through validated clinical scales administered by investigators.

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