Search Results

The Cefaly® device is indicated for the prophylactic treatment of episodic migraine in patients 18 years of age or older.

Cefaly® device is a supraorbital transcutaneous 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.

Cefaly® is operated by a rechargeable battery. A pressure on the single switch starts a program, which runs automatically for 20 minutes.

The electrical impulses generated by the Cefaly® device are transmitted transcutaneously via the supraorbital electrode to excite (trigger action potentials) 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 a sedative effect and is intended to treat migraine headaches.

This document describes the CEFALY® device, a supraorbital transcutaneous nerve stimulator for the prophylactic treatment of episodic migraine. It is a 510(k) premarket notification for a modified version of an already legally marketed device.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes a 510(k) for a modified version of the CEFALY® device. The core of this submission is substantial equivalence to a predicate device (the original CEFALY® device, De Novo Number DEN120019 and 510(k) Number K122566). The document explicitly states that the "scientific technology of the modified Cefaly® device are identical to those of the original version of the Cefaly® device" and "The modified version of the Cefaly® has exactly the same output stimulation parameters than the legally marketed Cefaly®."

Therefore, the acceptance criteria are implicitly that the modified device's performance, particularly its safety and effectiveness for its indicated use, is equivalent to the predicate device. The performance is reported as being identical to the predicate.

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

The provided document for the 510(k) (K160237) does not describe a new clinical study with an independent test set for the modified device. Instead, it relies on demonstrating substantial equivalence to a predicate device. The modifications concern "power supply, the dimensional specifications, and the fixing system between the device and the electrode." The submission indicates that a "risk analysis did not show any unacceptable risk resulting from these device modifications."

Therefore, there is no information about a "test set" in the context of evaluating a new algorithm or clinical performance for this specific 510(k) submission. Any clinical data supporting the original predicate device (DEN120019, K122566) would be the basis for efficacy and safety, but that data is not detailed in this document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

As there is no new clinical study or test set described for the modified device in this 510(k) submission, this information is not available in the provided text.

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

Not applicable, as no new test set is described.

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

Not applicable. The device is a transcutaneous electrical nerve stimulator, not an AI-powered diagnostic or assistive tool for human readers.

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

This refers to an algorithm-only performance study. The CEFALY® device is a physical medical device (nerve stimulator), not an algorithm or AI. Hence, this question is not applicable in the context of this device.

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

For the predicate device, the "ground truth" for its safety and effectiveness would have been established through clinical trials and medical assessments related to migraine frequency, intensity, and duration, as well as adverse events. The specific methodologies (e.g., patient-reported outcomes, physician diagnosis, headache diaries) are not detailed in this 510(k) summary but would have been part of the original De Novo or 510(k) submission for the predicate. For this modified device, the "ground truth" is its equivalence to the predicate device's established performance based on identical stimulation parameters and a risk analysis of the changes.

8. The sample size for the training set

Not applicable, as this is a physical medical device, not an AI/ML algorithm that requires a "training set."

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

Not applicable, as this is a physical medical device.

Ask a specific question about this device