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Cefaly Dual Connected - OTC and Cefaly Dual Enhanced with RFID - OTC are indicated for:

1. Acute treatment of migraine with or without aura in patients 18 years of age or older
2. Preventative treatment of migraine in patients 18 years of age or older

Cefaly Dual Connected - Rx and Cefaly Dual Enhanced With RFID - Rx are indicated for:

1. Acute treatment of migraine with or without aura in patients 18 years of age or older
2. Prophylactic treatment of migraine in patients 18 years of age or older

The Cefaly® Dual Series of devices are small, non-invasive, and portable devices meant to be worn on the forehead using a self-adhesive electrode to treat migraine similar to Cefaly® Dual (K201895 OTC and K173006 R.). The devices are similar in construction and materials and use the same components (electronics and electrical components, and firmware), including the component that comes into patient contact which is the CEFALY® Electrode. The notable differences between the Subject and Predicate devices are Bluetooth technology and mobile application for the purpose of displaying device data, the new docking station, RFID for electrode detection, audio/visual indicators, and the dimensions and the weight of the electrode.

The provided text is a 510(k) premarket notification for the Cefaly Dual Series devices. It details the device's characteristics and compares them to predicate devices to demonstrate substantial equivalence. Crucially, this document does not contain information about a study that proves the device meets specific acceptance criteria in the format typically used for demonstrating the performance of a novel AI/ML-based medical device.

The document states:

• "No animal testing was required to justify the differences with the corresponding Predicate Devices." (page 40)
• "No clinical testing was required to justify the differences with the corresponding Predicate Devices." (page 40)

This indicates that the submission relies on demonstrating substantial equivalence to existing devices through bench testing and comparison of technological characteristics, rather than new clinical performance data to prove efficacy. The changes made to the device (e.g., Bluetooth, RFID, audio/visual indicators, charging system, weight, dimensions, electrode thickness, packaging) are assessed against safety and electrical standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10) and adhesion performance.

Therefore, I cannot provide the requested information for a study proving acceptance criteria for an AI/ML device because:

• No acceptance criteria for an AI/ML device are listed. The document pertains to a Transcutaneous Electrical Nerve Stimulator, not a device incorporating AI/ML for diagnostic or therapeutic decision-making.
• No study proving device performance against such criteria is presented. The "Performance Testing - Bench" section (Table 5.7.1) lists general electrical and EMC safety standards, and adhesion testing for electrodes, but not performance metrics related to migraine treatment outcomes that would typically be evaluated in a clinical trial.

Without a study described as such in the provided text, I cannot fill in the requested table or additional details. The information provided heavily focuses on hardware changes and their compliance with general safety standards, and substantiates that the functionality of the device (e.g., electrical stimulation parameters) remains equivalent to the cleared predicate devices, thus not requiring new clinical evidence of effectiveness for migraine treatment.

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