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The Cefaly® Acute 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 Cefaly® Acute is operated by a rechargeable battery. A pressure on the single switch starts a program, which runs automatically for 60 minutes.

AI/ML Overview

This document describes the Cefaly® Acute device and its substantial equivalence to a predicate device (Cefaly®). It includes a summary of a clinical trial used to support its safety and efficacy.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" for the device's performance in a table format with specific numerical targets. However, the primary outcome of the clinical study serves as the de-facto performance measure demonstrating efficacy. The performance of the Cefaly® Acute is compared against a sham group.

Acceptance Criteria (Implied)	Reported Device Performance (Cefaly® Acute)	Reported Device Performance (Sham Group)	Statistical Significance
Reduction in pain score from baseline to 1 hour	Mean change in VAS pain score: -3.46 ± 2.32	Mean change in VAS pain score: -1.78 ± 1.89	Statistically significant (p < 0.05 for treatment difference of -1.68)
Pain relief at 2-hour and 24-hour time points	Observed	Observed	Observed
Anti-migraine rescue medication intake within 24 hours	Not significantly lower (implies no specific numerical target met or not achieved statistical significance)	Not significantly lower	Not statistically significant

2. Sample Size and Data Provenance

Test Set Sample Size: 106 patients (93 females and 13 males). This refers to the clinical study population.
Data Provenance: The document does not explicitly state the country of origin. The study is described as a "Randomized, sham-controlled clinical trial," indicating it was a prospective study.

3. Number of Experts and Qualifications for Ground Truth

This information is not provided in the document. The study measures patient-reported pain scores (VAS), not an interpretation by experts like radiologists. Therefore, there's no mention of experts establishing ground truth in the context of image interpretation or similar tasks.

4. Adjudication Method for the Test Set

This information is not applicable/not provided as the primary outcome measure (VAS pain score) is a patient-reported outcome, not an interpretation requiring adjudication by multiple readers.

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

A MRMC comparative effectiveness study was not done. This type of study typically applies to imaging diagnostics where human readers interpret medical images. The Cefaly® Acute is a therapeutic device for pain management, and its efficacy was assessed through a randomized, sham-controlled clinical trial directly measuring patient outcomes.

6. Standalone (Algorithm Only) Performance Study

A standalone performance study was not done. The Cefaly® Acute is a device, not an algorithm in the typical sense of AI/ML software. Its performance is measured by its therapeutic effect on patients, not by its ability to process data independently of human interaction.

7. Type of Ground Truth Used

The ground truth used was patient-reported outcomes, specifically the change in pain score from baseline measured on an 11-point Visual Analog Scale (VAS).

8. Sample Size for the Training Set

This information is not applicable/not provided. The Cefaly® Acute is a medical device, not an AI/ML algorithm that requires a training set in the conventional sense. The document describes a clinical trial evaluating the therapeutic effect of the device.

9. How the Ground Truth for the Training Set was Established

This information is not applicable/not provided for the same reason as point 8.

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