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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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The 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.

The Neriviolnfinity 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 NerivioInfinity 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 0-40mA), to start, pause or stop the stimulation program, and to view device status such as the device's connection state, stimulation, battery level (when connected to NerivioInfinity), 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 NerivioInfinity 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.

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided FDA 510(k) summary:

The core of this submission is to expand the indicated age range of the Nerivio and NerivioInfinity devices to include children aged 8-11. Therefore, the acceptance criteria and study focus on demonstrating the safety and effectiveness of the device in this younger population, showing it is comparable to its performance in the previously cleared adolescent and adult populations.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is an age range expansion for an already cleared device, the "acceptance criteria" are implicitly demonstrating comparable safety and effectiveness in the new age group (8-11 years old) to the previously cleared age group (12 years and older). The performance metrics align with what would be expected for a migraine treatment device.

Implicit Acceptance Criteria (for the 8-11 age group) and Reported Device Performance:

*Note: The study population included patients aged 6-11 years old. The device indication sought and granted in the 510(k) is for 8 years of age or older. The use of data from 6-7 year olds in the study would further support the safety and effectiveness for 8-11 year olds, as younger children might present more challenges in terms of compliance or adverse events.

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

• Sample Size: The clinical investigation included n=293 patients aged 6-11 at their first use of Nerivio (for safety and overall usage patterns in the real world). For effectiveness endpoints (acute treatment), analyses were performed on a subset of patients who completed voluntary pre- and post-treatment surveys, with the number of patients varying for each specific outcome (e.g., 18 for headache relief, 25 for headache freedom, 18 for functional disability, 10 for nausea/vomiting, 8 for phonophobia, 9 for photophobia).
• Data Provenance: The study consisted of a retrospective analysis of prospectively-collected real-world data for children in the United States. The data was collected between May 2020 to October 2023.

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

This type of study does not involve expert readers establishing ground truth in the traditional sense (e.g., for image interpretation). The "ground truth" for effectiveness is patient-reported outcomes of migraine symptoms, consistent with how efficacy trials for migraine treatments are typically conducted. Safety data is collected via customer service reports, which are also patient-reported or initiated.

4. Adjudication Method for the Test Set

Not applicable in this context. Adjudication methods (e.g., 2+1, 3+1) are typically used in studies where multiple expert readers interpret subjective data (like medical images) and their disagreements need to be resolved to establish ground truth. This study relies on patient-reported outcomes for effectiveness and adverse event reporting for safety.

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. This device is a standalone therapeutic device for migraine treatment, not an AI-assisted diagnostic tool that would involve human "readers" interpreting cases.

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

This is a device that directly treats a condition; it's not an AI algorithm that provides a diagnosis or analysis. Therefore, a "standalone algorithm performance" evaluation is not relevant in the same way it would be for an AI diagnostic device. The device's performance is its direct therapeutic effect, not its output as an algorithm.

7. The Type of Ground Truth Used

The ground truth for effectiveness was patient-reported outcomes (PROs) on migraine symptoms (headache pain, functional disability, nausea/vomiting, phonophobia, photophobia) via voluntary pre- and post-treatment surveys. For safety, the ground truth was based on reported adverse events through customer service complaints and other product issue reports.

8. The Sample Size for the Training Set

Not applicable. This is not a study validating an AI model that requires a distinct training set. The clinical investigation is a real-world study assessing the device's performance in a new age group. The "knowledge" or "training" for the device itself comes from its prior development and existing clinical data which supported its previous clearances for older populations.

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

Not applicable, as there is no "training set" in the context of an AI/ML model for this specific submission. The established efficacy and safety data from prior clinical trials in adolescents and adults (e.g., K223169 and K232152) serve as the benchmark against which the performance in the 8-11 age group is compared for equivalence.

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The Nerivio is intended for acute treatment of migraine with or without aura in patients 18 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.

The Nerivio is a wearable, battery-powered device that is controlled by a mobile application. The system delivers low energy electrical pulses to the upper arm for 45 minutes per treatment, after which the device turns off automatically. The device hardware consists of an armband intended to be worn on a user's upper arm. The armband contains the electronic circuitry and the battery in a plastic storage case as well as two electrodes that are attached to the interior of the armband and placed against the user's skin. The device is operated and controlled via software that is installed and run on a user's personal mobile device such as a mobile phone or tablet. The device hardware communicates with the mobile application through a Bluetooth protocol. This mobile application software allows the user to control the stimulation intensity from 0 to 100% (representing intensity levels of 0- 40mA), to start or stop the stimulation program, and to view device status such as the device's connection state, a progress bar for stimulation duration, battery level, and user notifications. The patient is instructed to adjust the intensity to the strongest stimulation level below the perceived pain level. Treatments with Nerivio are intended to be self-administered by the user immediately after the onset of migraine headache or aura.

The provided document describes the Nerivio device and its substantial equivalence to a predicate device (Nerivio Migra), primarily based on clinical studies rather than an AI/ML algorithm's performance. Therefore, many standard AI/ML acceptance criteria and study elements (like training set size, ground truth for training, expert adjudication, MRMC studies, standalone performance with metrics like sensitivity/specificity, or specific effect sizes of AI with human readers) are not present in this document.

However, I can extract the acceptance criteria and performance data related to the clinical studies conducted for device efficacy and safety as described in the provided text. The "acceptance criteria" here refer to the primary efficacy endpoints defined for the clinical trials, which demonstrate the device's effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document outlines clinical study endpoints as measures of device performance, which serve as "acceptance criteria" for demonstrating efficacy and safety. The primary endpoint for efficacy was "pain relief at 2 hours post-treatment."

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

The clinical studies acted as the primary "test set" for validating the device's performance.

• Study 1 Sample Size:
  • 42 patients recruited initially.
  • 38 participants completed at least one treatment in response to a migraine.
  • 296 qualifying migraine headaches treated.
• Study 2 Sample Size:
  • 97 participants completed at least one treatment.
  • 91 participants formed the final analysis set for test treatment.
  • 493 evaluable treatments of qualifying migraine headaches conducted.
• Data Provenance: The document states that Study 2 was conducted at 9 sites in the USA. Study 1 was conducted at 2 sites, but the country of origin is not explicitly stated, although it's within the context of FDA submission, suggesting US or international sites adhering to US standards. Both studies were prospective, open-label, single-arm, multicenter studies.

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

The concept of "experts" establishing ground truth in the traditional sense of medical image analysis (e.g., radiologists) is not applicable here. The ground truth for efficacy was self-reported by the patients using an electronic diary application:

• Pain scores: Self-reported by participants (e.g., severe or moderate pain to mild or none, or mild pain to none).
• Absence/presence of associated migraine symptoms: Self-reported.
• Functional disability: Self-reported.

The diagnostic criteria for chronic migraine (ICHD-3) were applied to select eligible participants, implying medical professionals (neurologists/headache specialists) were involved in patient selection. However, their role wasn't in establishing ground truth for individual treatments but in determining study eligibility.

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

No specific adjudication method (like 2+1 or 3+1 for expert review) is mentioned for the patient-reported outcomes. Given that the data collected was patient self-reported via an electronic diary, it implies direct measurement of patient experience, not subject to expert adjudication of the outcome itself, although clinical staff would have monitored data collection.

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

This is not an AI/ML device, and no MRMC comparative effectiveness study involving human readers or AI assistance was conducted or reported. This device is a direct treatment device, not a diagnostic imaging or AI-assisted diagnostic tool.

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

This is not an AI/ML algorithm. The device, Nerivio, operates as a standalone therapeutic device that patients self-administer. Its "performance" refers to its direct therapeutic effect on migraine symptoms.

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

The "ground truth" for the efficacy studies was primarily patient-reported outcomes data. This includes:

• Self-reported pain levels (e.g., severe, moderate, mild, none).
• Self-reported presence or absence of associated migraine symptoms (nausea, photophobia, phonophobia).
• Self-reported functional ability.

8. The sample size for the training set

The concept of a "training set" in the context of an AI/ML algorithm is not applicable here. The device does not employ an AI/ML model that requires training data. The "training treatment" mentioned in Study 2 (97 participants completed at least one training treatment) refers to an initial treatment session to familiarize participants with the device, not an AI model training phase.

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

Not applicable, as there is no AI/ML training set. The "training treatment" phrase refers to the initial use of the device by patients.

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