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Nerivio is indicated for acute and/or preventive treatment of migraine with or without aura in patients 8 years of age or older. It is a prescription use, self-administered device for use in the home environment at the onset of migraine headache or aura for acute treatment, or every other day for preventive treatment.

Nerivio Infinity is indicated for acute and/or preventive treatment of migraine with or without aura in patients 8 years of age or older. It is a prescription use, self-administered device for use in the home environment at the onset of migraine headache or aura for acute treatment, or every other day for preventive treatment.

The Nerivio and Nerivio Infinity are wearable, battery-powered, Remote Electrical Neuromodulation (REN) devices that are controlled by a mobile application. The systems deliver low energy electrical pulses to the upper arm for 45 minutes per treatment, after which the device turns off automatically.

The devices are composed of:

• A pair of UltraStim® electrodes (K130987) covered with hydrogel and removable protective film. In NerivioInfinity, the electrodes are embedded in a disposable, replaceable pad. In Nerivio, the electrodes are not disposable or replaceable.
• An electronic circuitry that includes microcontroller with firmware, LED indicator, a power button for activating the device, and Bluetooth radio for wireless connection to Android and iOS mobile platforms. The circuitry also includes a battery, which is rechargeable in NerivioInfinity and not rechargeable in Nerivio.
• An armband that is wrapped over the device to secure the device position on the user's arm is also included.

The devices are operated and controlled via mobile application software that is installed and run on the user's personal mobile device, such as a mobile phone or tablet. The device's hardware communicates with the mobile application through Bluetooth protocol. This mobile application software allows the user to control the stimulation intensity from 0 to 100% (representing intensity levels of 0-40 mA), to start, pause or stop the stimulation program, and to view device status such as the device's connection state, stimulation duration, battery level (when connected to Nerivio Infinity), remaining number of treatments (when connected to Nerivio), and user notifications.

The user is instructed to adjust the intensity to the strongest stimulation level just below the perceived pain level. Treatments with Nerivio and Nerivio Infinity are intended to be self-administered by the user immediately after the onset of migraine headache or aura or every other day for migraine prevention.

The provided FDA 510(k) clearance letter and summary for Nerivio and Nerivio Infinity primarily focus on demonstrating substantial equivalence to a previously cleared predicate device (K241756). It discusses minor changes and states that extensive non-clinical and clinical testing was not needed for this specific 510(k) submission because of the close similarity to the predicate.

Therefore, the document does not contain detailed acceptance criteria and studies demonstrating device performance against those criteria in the way one might expect for an initial device clearance or a completely new technology. Instead, it refers to existing knowledge and prior clearances, and specifically addresses the basis for revising certain labeling precautions.

I will extract the information available, acknowledging the limitations inherent in this type of submission.

1. Table of Acceptance Criteria and Reported Device Performance

As this K250405 submission is for modifications to an already cleared device, it doesn't present new acceptance criteria or new primary performance study results in the typical format. Instead, it relies on the predicate device's established performance and justifies that the minor changes do not raise new questions of safety or effectiveness. The "reported device performance" here relates to the basis for modifying labeling precautions.

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

• For long-term use data:
  • Sample Size: Not explicitly stated in the 510(k) document, but the cited study (Synowiec A, et. al. Adv Ther. 2024 Jan;41(1):170-18) would contain this information. The description mentions "real-world data on use of Nerivio collected from US patients."
  • Data Provenance: United States patients, retrospective (post-market studies).
• For pregnancy data:
  • Sample Size: Not explicitly stated in the 510(k) document, but the cited study (Peretz A, et. al. Headache. 2023;63(7):968-970) would contain this information.
  • Data Provenance: Not explicitly stated regarding country, but described as a "retrospective survey-study."

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

This information is not provided in the 510(k) document. The cited studies are "post-market studies of real-world data" and a "retrospective survey-study," which typically rely on patient-reported outcomes or clinical records rather than expert adjudication for ground truth directly related to device performance in the same way, for example, a diagnostic imaging AI would.

4. Adjudication Method for the Test Set

This information is not provided in the 510(k) document. Given the nature of the evidence (real-world data, survey), formal adjudication by a panel of experts for a test set is unlikely to have been the primary method for establishing "ground truth."

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

No, an MRMC comparative effectiveness study was not done and is not applicable to this device or its clearance. Nerivio/Nerivio Infinity is a direct therapeutic device, not an AI-assisted diagnostic tool that involves human "readers."

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

N/A. This device is a transcutaneous electrical nerve stimulator for migraine treatment, not an algorithm that performs a standalone task for evaluation. It is a user-controlled device with specific treatment parameters. The "algorithm" in this context refers to the device's firmware controlling the stimulation, which is part of the integrated device used by the patient. Its performance is evaluated through patient response to the therapy, not an "algorithm-only" performance in isolation.

7. The Type of Ground Truth Used

• For long-term use data: Patient-reported outcomes and potentially clinical records from "real-world data on use of Nerivio."
• For pregnancy data: Patient responses from a "retrospective survey-study."
• The fundamental "ground truth" for therapeutic neurological devices like this is reduction in migraine symptoms, frequency, and severity, typically assessed through patient diaries and validated questionnaires. This specific 510(k) focuses on validating the safety aspects of long-term and pregnancy use, drawing from real-world data.

8. The Sample Size for the Training Set

The document does not contain information about a "training set" in the context of machine learning, as this is a neuromodulation device, not an AI/ML diagnostic or predictive algorithm being trained. The development of the device's therapeutic parameters would have been established through prior clinical trials (likely supporting the predicate device's initial clearance) and engineering design, not an ML training process.

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

N/A, as there is no "training set" in the context of machine learning described in this 510(k) submission. The efficacy and safety data upon which the device's design and indications are based would have come from the clinical trials that established the predicate device's clearance.

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