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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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