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The ADDNOX is indicated for the 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 ADDNOX is intended for patient treatment by prescription only and for use at home under the supervision of a caregiver during periods of sleep.

The ADDNOX is a transcutaneous electrical trigeminal nerve stimulator for Attention Deficit Hyperactivity Disorder. It is a prescription device that stimulates transcutaneously or percutaneously through electrodes placed on the forehead.

The ADDNOX is intended for patient treatment by prescription only and for use at home under the supervision of a caregiver during periods of sleep.

The provided text describes a 510(k) premarket notification for the ADDNOX device, a transcutaneous electrical nerve stimulator for Attention Deficit Hyperactivity Disorder (ADHD). However, it explicitly states:

"No clinical testing was performed on the device."

This means that the submission does not include a study demonstrating device performance against specific acceptance criteria. The clearance for ADDNOX is based on its substantial equivalence to a legally marketed predicate device (SMILE) and non-clinical data (biocompatibility, electrical safety, performance, and software tests).

Therefore, I cannot fulfill your request to describe acceptance criteria and a study proving the device meets them, nor can I provide information about sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, or ground truth establishment for a clinical study, as these were not part of this 510(k) submission.

The document focuses on demonstrating that the ADDNOX has similar technological characteristics and performs as safely and effectively as the predicate device through non-clinical testing and comparison.

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The BT-1000 external Trigeminal Nerve Stimulation System 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 to be 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.

Electrical stimulator that alleviate the symptoms of Attention Deficit Hyperactivity Disorder (ADHD), a psychological mental disorder, by non-invasively stimulating cranial nerves with fine electrical stimulation using extracorporeal electrodes. The treatment protocol using the BT-1000 is administered each night while the patient is sleeping, for 7-9 hours. The device is designed to provide non-invasive electrical stimulation of the trigeminal nerve via an electrode placed on the forehead.

The provided document, a 510(k) Summary for the BT-1000 device, describes the device's technical specifications and performance testing but does not include a study proving the device meets acceptance criteria related to its clinical efficacy in treating ADHD.

Instead, the document focuses on demonstrating substantial equivalence to a predicate device (Monarch eTNS System) based on technical specifications and non-clinical performance. The "acceptance criteria" presented are primarily related to safety, electrical performance, and physical integrity of the device components, rather than clinical effectiveness for ADHD treatment.

Therefore, I can provide information based on the safety and performance acceptance criteria and related tests, but not for a clinical efficacy study.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical/Safety Focused)

The document primarily shows a comparison table for substantial equivalence, where the "acceptance criteria" are implied by matching the predicate device's specifications and by meeting recognized safety and electrical standards. The "reported device performance" is a statement that the device complied with these specifications or passed the tests.

2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a clinical test set for evaluating the device's efficacy in ADHD treatment. All tests mentioned are non-clinical (bench testing, biocompatibility, electrical safety). Therefore, there is no information on a "sample size for the test set" in a clinical context or data provenance in terms of country of origin of patient data.

• For biocompatibility, the tests were performed on standard laboratory models/materials as per ISO standards.
• For electrical safety, EMC, and performance bench testing, the "test set" would be the device itself and its components, or simulated environments.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as there was no clinical test set requiring expert adjudication for ground truth. For non-clinical tests, "ground truth" is defined by the parameters of the test standards (e.g., ISO, IEC).

4. Adjudication Method for the Test Set
This information is not applicable due to the absence of a clinical test set requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No. A MRMC comparative effectiveness study was not done. The submission explicitly states: "No clinical studies were considered necessary and performed." The device relies on substantial equivalence to a predicate, which would have undergone clinical testing, but this document does not contain such a study for the BT-1000.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
Not applicable in the context of clinical efficacy for ADHD. The BT-1000 is an electrical stimulation device, not an "algorithm only" device in the sense of AI-powered diagnostic/interventional software. Its safety and technical performance were assessed without human-in-the-loop performance studies, but these were for non-clinical aspects.

7. The Type of Ground Truth Used
For the non-clinical tests (biocompatibility, electrical safety, performance bench tests), the "ground truth" is established by:

• International Standards: e.g., ISO 10993 series for biocompatibility, IEC 60601 series for electrical safety and EMC.
• Device Design Specifications: The device is tested against its own design specifications (e.g., for stimulation output, battery performance, duration, electrode properties).
• Predicate Device Specifications: Many "acceptance criteria" are based on matching the technical specifications of the legally marketed predicate device (Monarch eTNS System) to demonstrate substantial equivalence.

8. The Sample Size for the Training Set
Not applicable. This document describes a medical device, not a machine learning or AI algorithm that would typically have a "training set" for model development. The software validation mentioned pertains to standard software development lifecycle processes and verification/validation, not AI model training.

9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no "training set" for an AI model, this question does not apply.

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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 SMILE external Trigeminal Nerve Stimulation (eTNS) System 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 to be 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.

Transcutaneous electrical nerve stimulator for Attention Deficit Hyperactivity Disorder. A transcutaneous electrical nerve stimulator for Attention Deficit Hyperactivity Disorder (ADHD) is a prescription device that stimulates transcutaneously or percutaneously through electrodes placed on the forehead.

The SMILE eTNS System treatment protocol is administered each night while the patient is sleeping, for 7-9 hours. The device is designed to provide non-invasive electrical stimulation of the trigeminal nerve.

The provided document is a 510(k) summary for the Nu Eyne Co., Ltd. SMILE device, a transcutaneous electrical nerve stimulator for Attention Deficit Hyperactivity Disorder (ADHD). This document focuses on demonstrating substantial equivalence to a predicate device (Monarch eTNS System), rather than presenting a clinical study where the device performance against specific acceptance criteria is measured for an AI/algorithm-driven device.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, expert involvement, adjudication, MRMC studies, standalone performance, and ground truth establishment for an AI/algorithm is not available in this document.

The document details the device's technical specifications, indications for use, and a comparison to a predicate device to establish substantial equivalence. It also lists the non-clinical tests performed (electrical safety, EMC, performance, usability, and software validation according to relevant standards), which support the device's safety and effectiveness in general, but not a specific performance metric against a clinical acceptance criterion in the context of an AI/algorithm.

To directly answer your request based only on the provided text, I must state that the information is not present. This document describes a medical device clearance process focused on equivalence, not on the performance of a machine learning algorithm against a clinical endpoint with a dedicated test set and ground truth.

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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.

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