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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 Neriviolnfinity is indicated for acute and/or preventive treatment of migraine with or without aura in patients 12 years of age or older. It is a prescription use, self-administered device for use in the onset of migraine headache or aura for acute treatment, or every other day for preventive treatment.

The Neriviolnfinity 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 is composed of: A pair of UltraStim® electrodes (K130987) covered with hydrogel and removable protective film, embedded in an electrodes pad set. The electrodes pad is disposable and replaceable. An electronic circuitry that includes microcontroller with firmware and for wireless connection to Android and iOS mobile platforms, LED indicator, a USB-C charging port, a power button for activating the device and a battery contained in a plastic enclosure. An armband that is wrapped over the device to secure the NerivioInfinity position on the user's arm is included. The device is 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 duration, battery level, and user notifications.

The provided text is a 510(k) summary for the NerivioInfinity device. It details the device, its intended use, and a comparison to a predicate device (Nerivio). However, it does not contain the information requested regarding acceptance criteria, specific performance data (beyond "functioned as expected"), sample sizes for testing, ground truth establishment, or multi-reader multi-case studies.

The summary explicitly states: "No clinical trials were performed with the subject device, given that the therapeutic elements (electrodes, electrical waveform, location on the body, treatment instructions, treatment duration, etc.) are the same as in the predicate device." This means that the device's performance was not evaluated through a new clinical study. Instead, substantial equivalence was claimed based on its similarity to the predicate device, which presumably underwent clinical testing for its original clearance.

Therefore, I cannot provide a table of acceptance criteria and reported device performance from this document for the NerivioInfinity, nor details about its test set, ground truth establishment, or clinical study design, as these were not conducted for this specific device clearance.

The "Performance Data" section solely describes non-clinical bench tests and usability tests.

Here's what can be extracted based on the provided text, while also noting what cannot be provided:

1. A table of acceptance criteria and the reported device performance:

• Cannot be provided for the NerivioInfinity from this document. The document states that "No clinical trials were performed with the subject device." The "Performance Data" section refers to non-clinical bench tests and usability tests, stating that "In all instances, the NerivioInfinity functioned and expected." No specific quantitative acceptance criteria or performance metrics (e.g., sensitivity, specificity, accuracy, or clinical efficacy outcomes like pain reduction percentages) are detailed for the non-clinical tests.

2. Sample sizes used for the test set and the data provenance:

• A "test set" in the context of clinical performance or AI evaluation (as implied by the question) was not used for this device's clearance according to the document.
• For non-clinical bench tests and usability tests: The specific sample sizes are not provided. The document mentions "internal bench tests and external lab testing" and "Human factor (Usability) tests were performed to validate that all critical tasks related to use-errors and knowledge errors were successfully performed by representative intended users." No details on the number of "representative intended users" or the number of units tested are given.
• Data provenance: N/A for clinical data directly from this device's testing. For the non-clinical tests, the provenance is "internal bench tests" and "external lab testing" without further geographical details. The company is based in Netanya, Israel.

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

• N/A. As no clinical "test set" for performance evaluation (in the sense of the original prompt's context, i.e., diagnostic accuracy or clinical efficacy) was used for this device's clearance, there was no need for experts to establish ground truth in that context. Usability tests involved "representative intended users" but not "experts" establishing "ground truth" on medical outcomes.

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

• N/A. No clinical test set.

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:

• N/A. This device is a direct neuromodulation device, not an AI-assisted diagnostic or therapeutic device that would typically involve human "readers" or an MRMC study.

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

• N/A. This device is a standalone therapeutic device, not an algorithm. Its performance is evaluated through its physical and electrical characteristics and clinical outcomes (established by the predicate device's studies).

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

• N/A for the NerivioInfinity's clearance under this 510(k). The basis for clearance is "substantial equivalence" to the predicate device, meaning its safety and effectiveness are inferred from the predicate's established performance. For the predicate device, it would have been clinical outcomes data (e.g., migraine reduction, pain relief).

8. The sample size for the training set:

• N/A. This device does not have a "training set" in the context of machine learning or AI.

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

• N/A. This device does not have a "training set."

Summary of Device Performance (from the document but not necessarily "acceptance criteria"):

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