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The Cefaly® Dual is indicated for

• The acute treatment of migraine with or without aura in patients 18 years of age or older.
• The prophylactic treatment of episodic migraine in patients 18 years of age or older.

The Cefaly® Dual device indicated for an OTC (also referred to as the Subject Device) is a supraorbital transcutaneous electrical nerve stimulator device to be applied on the forehead. A self-adhesive electrode with 2 conductive zones is placed on the forehead. This double electrode is directly connected to the device. The Subject Device is operated by a rechargeable battery. Pressure on the single button allows selecting and starting a stimulation program, which runs automatically. The electrical impulses generated by the Subject Device are transmitted transcutaneously via the supraorbital electrode to excite (trigger action potentials on) the supratrochlearis and supraorbitalis nerves. Supratrochlearis and supraorbitalis (or supratrochlear and supraorbital) nerves belong to the upper branch of the trigeminal nerve (V1). Therefore, the supraorbital neurostimulation is also known as external trigeminal nerve stimulation. The supraorbital neurostimulation generates an analgesic effect and is intended to treat migraine headaches.

This document is a 510(k) premarket notification approval letter for the Cefaly® Dual device, indicating its substantial equivalence to a previously cleared predicate device. It primarily focuses on the device's technological characteristics, indications for use, and a non-clinical human factors study to support a change from prescription (Rx) to over-the-counter (OTC) use.

Based on the provided text, the device itself does not involve an AI/ML algorithm that requires specific acceptance criteria related to its performance in tasks like image classification or predictive modeling. Instead, it's a Transcutaneous Electrical Nerve Stimulator (TENS) device. Therefore, many of the requested points regarding AI/ML acceptance criteria, performance metrics (like sensitivity, specificity, AUC), ground truth establishment, training sets, and MRMC studies are not applicable to this submission.

The "study that proves the device meets the acceptance criteria" in this context refers to demonstrating the device's equivalent performance and safety to its predicate, particularly for its proposed OTC use.

Here's a breakdown based on the document:

Acceptance Criteria for Cefaly® Dual (for OTC use):

The acceptance criteria are implicitly tied to demonstrating the substantial equivalence to the predicate device (Cefaly® Dual K173006) and showing that the device is safe and effective for over-the-counter use without requiring a prescription.

The document highlights the following as crucial for demonstrating equivalence/acceptance:

• Identical Technological Characteristics: The device must be technologically identical to the predicate device in design, materials, energy source, electrical impulse parameters (pulse width, frequency, current, waveform), and software.
• Identical Intended Use/Clinical Application: The clinical application and intended users (patients 18 years or older for acute treatment of migraine with or without aura, and prophylactic treatment of episodic migraine) must remain the same as the predicate.
• Safety and Effectiveness for OTC Use: The primary additional "acceptance criterion" for the OTC claim is demonstrating that the device can be used safely and effectively by lay users without professional guidance. This is addressed through a Human Factors validation study.

Study Proving Device Meets Acceptance Criteria:

The study that proves the device meets the (implicit) acceptance criteria for OTC marketing is primarily a Non-Clinical Human Factors Validation Study.

1. Table of Acceptance Criteria (Implicit) and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:

• Test Set Sample Size: The document only mentions a "Human Factors validation study" but does not specify the sample size for this study.
• Data Provenance: Not explicitly stated, but Human Factors studies are typically prospective tests conducted in a simulated or real-world use environment. The manufacturer is CEFALY Technology, based in Belgium, so participants could be from Europe or the US, but this is not detailed.

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

• This question is not applicable in the context of this device. A TENS device does not generate data that requires expert labeling or ground truth establishment in the way an AI/ML algorithm for medical image analysis would.
• For Human Factors studies, "experts" are typically human factors specialists, usability engineers, and potentially clinicians who understand the device's use environment, rather than experts establishing "ground truth" in clinical data. The document does not detail the expertise of those involved in the human factors study design or evaluation.

4. Adjudication Method for the Test Set:

• Not applicable for this type of device and study. Human Factors studies involve observing user interactions, identifying use errors, and assessing user comprehension, rather than adjudicating clinical findings.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:

• No, this was not done. The device cleared via a 510(k) pathway by demonstrating substantial equivalence to a predicate. The document explicitly states: "Clinical performance testing was not performed with the Subject Device to support equivalence, as there are no differences between the Subject Device and the Predicate Device."
• MRMC studies are typically for AI/ML algorithms where human performance with and without AI assistance is being compared. This device is a direct-to-patient TENS.

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

• Not applicable. This device is hardware with simple embedded software. It is not an AI/ML algorithm that operates in a "standalone" analytical capacity. Its performance is tied directly to its hardware function and user interaction.

7. The Type of Ground Truth Used:

• Not applicable for clinical efficacy. As noted, clinical performance testing was not performed for this submission. The "ground truth" for the Human Factors study would be the identification of all potential use errors and the successful demonstration that lay users can safely and effectively operate the device according to its instructions for use. This isn't "ground truth" in the diagnostic or prognostic sense.

8. The Sample Size for the Training Set:

• Not applicable. This device does not use an AI/ML algorithm that is "trained" on a dataset in the conventional sense. The software functions are fixed programs (Program 1 for acute treatment, Program 2 for prophylactic treatment) identical to the predicate device.

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

• Not applicable. See point 8.

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