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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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The Nerivio 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 home environment at the onset of migraine headache or aura for acute treatment, or every other day for preventive treatment.

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 is composed of a pair of UltraStim® electrodes (K130987) covered with hydrogel and removable protective film, an electronic circuitry that includes firmware, LED indicator and a power button for activating the device and for wireless connection with Android and iOS mobile platforms and a battery contained in a plastic case situated within thermoplastic elastomers ("TPE") shell. In addition, an armband that is wrapped over the device to secure the Nerivio position on the user's arm is included. 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, stimulation duration, remaining number of treatments, 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 are intended to be self-administered by the user immediately after the onset of migraine headache or aura.

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:

Device Name: Nerivio
Indications for Use (New/Expanded): 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 home environment at the onset of migraine headache or aura for acute treatment, or every other day for preventive treatment.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes a clinical study for the preventive indication for Nerivio, comparing it against a sham device. The "acceptance criteria" are implied by the primary and secondary efficacy endpoints of the clinical trial designed to demonstrate superiority over sham for migraine prevention.

2. Sample Size and Data Provenance

• Test Set Sample Size: 248 participants randomized (Active: 128, Sham: 120) for the Intent-to-Treat (ITT) dataset. Analysis for the primary endpoint was also performed on a modified ITT (mITT) dataset of 95 active and 84 sham participants (total 179) who completed at least 12 treatments.
• Data Provenance: The randomized, controlled trial was prospective and multicenter. While the specific countries are not mentioned, the context of FDA submission suggests it was likely conducted, at least primarily, within the United States. It was a prospective study.
• For the adolescent real-world data: 61 patients. Data collected prospectively through the Nerivio App between January 2, 2021, and November 26, 2022, from US patients.

3. Number of Experts and Qualifications for Ground Truth (Clinical Trial)

• The document does not explicitly state the number or qualifications of experts used to establish the ground truth for the clinical trial. However, the ground truth was based on participants' self-reported data using an electronic daily migraine diary application installed on their smartphones, following the International Classification of Headache Disorders (ICHD-3) criteria for migraine. This suggests that the diagnostic criteria were applied by healthcare professionals at the 15 study sites, who would be qualified to diagnose migraine. The assessment of efficacy endpoints (migraine days, headache days, medication usage) relied on the self-reported diary data.

4. Adjudication Method for the Test Set

• The document does not mention an adjudication method for the test set data (e.g., 2+1, 3+1 for imaging reads). The data collection for efficacy endpoints was through self-reported daily diaries.

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

• No, an MRMC comparative effectiveness study was not performed. This study was a Randomized Controlled Trial (RCT) comparing the device directly against a sham control for migraine prevention, not a study evaluating human reader performance with or without AI assistance.

6. Standalone Performance (Algorithm Only without Human-in-the-Loop)

• This device is a physical neuromodulation device, not an AI algorithm for diagnosis or image interpretation. Therefore, the concept of "standalone performance" for an algorithm without human-in-the-loop does not directly apply in the typical sense of AI/imaging devices. The "performance data" presented is clinical efficacy and safety data from a human-device interaction (patients using the device).

7. Type of Ground Truth Used

• For the main clinical trial: The ground truth for headache/migraine days and medication usage was established through patient self-reported daily migraine diaries collected prospectively via an electronic application on smartphones. Migraine diagnosis itself was based on ICHD-3 criteria.
• For the adolescent real-world data: Similar to the clinical trial, the ground truth for migraine headache days was collected through the Nerivio App from self-reported data.

8. Sample Size for the Training Set

• This device is not an AI/ML algorithm that requires a "training set" in the conventional sense of supervised learning. The device's mechanism of action is electrical neuromodulation, not a learned algorithm.
• The clinical trial mentioned (K223169) is a validation study for the new preventive indication, building upon prior studies (like K203181) for acute treatment. The "training data" for the device's design would effectively be the pre-clinical research and prior clinical studies that informed its development and established its mechanism of action (conditioned pain modulation).

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

• As a hardware medical device with a well-defined physical mechanism, there's no "training set" ground truth in the AI sense. The "ground truth" for the device's development and prior understanding of its mechanism (e.g., conditioned pain modulation) would be based on previous basic science, preclinical studies, and prior clinical trials (such as K203181 which established its acute treatment efficacy). The current submission leverages this existing knowledge and demonstrates expanded efficacy for prevention using a randomized controlled trial. For the extrapolation to adolescents, the "ground truth" relies on the established mechanism of action (CPM) being the same across age groups, supported by real-world evidence collected via the device's app.

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The Nerivio is indicated for acute 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 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 Nerivio is identical to the previously cleared Nerivio device with a modification to the indications for use to allow treatment in patients aged 12 years and older.

The device is composed of a pair of UltraStim® electrodes (K130987) covered with hydrogel and removable protective film, an electronic circuitry that includes firmware, LED indicator and a power button for activating the device and for wireless connection with Android and iOS mobile platforms and a battery contained in a plastic case situated within thermoplastic elastomers ("TPE") shell. In addition, an armband that is wrapped over the device to secure the Nerivio position on the user's arm is included.

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, stimulation duration, remaining number of treatments, and user notifications.

The patient is instructed to adjust the intensity to the strongest stimulation level just 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 text describes a clinical study for the Nerivio device, indicated for acute treatment of migraine. However, it does not detail acceptance criteria in the typical format of a table with specific metrics and thresholds for a device's performance. Instead, it presents results of clinical endpoints related to safety and efficacy.

Based on the provided text, here's an attempt to structure the information according to your request, inferring acceptance criteria from the reported efficacy outcomes:

1. Table of "Acceptance Criteria" (Inferred from Efficacy Endpoints) and Reported Device Performance

Note: The document does not explicitly state numerical acceptance thresholds. The "acceptance criteria" listed above are derived directly from the endpoints measured in the clinical study, implying that meeting these outcomes was considered sufficient for demonstrating safety and effectiveness for the expanded indication.

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

• Sample Size for Final Analysis Set (Test Set): 39 participants (adolescents aged 12-17 years old) for efficacy endpoints. A total of 45 participants entered the treatment phase, and safety analyses were performed on all 45.
• Number of treated migraine headaches: 159 qualifying migraine headaches.
• Data Provenance: Prospective, open-label, single-arm, multicenter study conducted at 12 sites in the USA.

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

The study involved self-reported pain scores, absence/presence of migraine-associated symptoms, and functional disability recorded by participants using an electronic diary application. The ground truth for headache diagnosis (ICHD-3 criteria for migraine) would have been established by healthcare professionals at the study sites; however, the number and specific qualifications of these professionals are not detailed in the provided text. No independent expert panel was used for establishing individual case ground truth during the treatment phase as data was self-reported.

4. Adjudication Method for the Test Set

No explicit adjudication method (like 2+1 or 3+1 consensus by experts) is described for the patient-reported outcomes that formed the test set. The data was collected directly from participants via electronic diaries. For "missing data" for the primary efficacy endpoint, a worst-case scenario imputation was used, where all treatments with missing pain level data were considered failures.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. This was a single-arm study evaluating the device's effect in adolescents, not a comparative effectiveness study involving human readers assisting AI or comparing human performance with and without AI assistance. The device functions as a direct treatment, not an AI diagnostic aid.

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

This question is not applicable in the context of this device. Nerivio is a medical device that delivers electrical stimulation for migraine treatment, not an algorithm, so evaluation of "standalone (algorithm only)" performance is not relevant. The performance evaluated is that of the device in use by humans.

7. The Type of Ground Truth Used

The ground truth for the effectiveness of the device was established based on:

• Patient-reported outcomes: Self-reported pain scores (mild, moderate, severe, none), presence/absence of associated symptoms (nausea, photophobia, phonophobia), and functional disability (via electronic diary).
• Validated questionnaire: Pediatric Migraine Disability Assessment (PedMIDAS) questionnaire for migraine-related disability.
• Safety data: Incidence and characteristics of adverse events reported by participants.

8. The Sample Size for the Training Set

The text does not refer to a "training set" in the context of machine learning, as this is a medical device for treatment, not an AI model. The study described is a clinical investigation to evaluate the device's safety and efficacy in a specific patient population (adolescents), thus acting as a validation study for the expanded indications.

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 model to which this question would apply. The "ground truth" for the device's intended use (migraine treatment) is established through clinical practice guidelines (ICHD-3 criteria for migraine diagnosis) and observed patient responses to treatment.

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The Nerivio Migra is indicated for acute treatment of migraine with or without aura in patients 18 years of age or older who do not have chronic migraine. It is a prescription use, selfadministered device for use in the home environment at the onset of migraine headache or aura.

The Nerivio Migra 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 Migra are intended to be self-administered by the user immediately after the onset of migraine headache or aura.

The basic pulse structure is biphasic, with symmetrical interleaving phases and rectangular shape. The amplitude shift signal alternates between a nominal maximum and a nominal minimum of the amplitude signal. The maximal output current is 40mA. The assumed impedance is 1K ohm +/- 500 ohms.

The provided text describes the regulatory information, device description, non-clinical/bench studies, and clinical study details for the Nerivio Migra device. It does not contain information about a study that specifically proves the device meets acceptance criteria in the formal sense often used for AI/ML medical devices (e.g., target metrics for sensitivity, specificity, or similar performance measures).

Instead, the document details a clinical trial designed to demonstrate the safety and effectiveness of the Nerivio Migra device for its intended use compared to a sham device. The "acceptance criteria" here are implicitly tied to the statistical significance and clinical meaningfulness of the primary and secondary endpoints in this clinical trial, as well as satisfactory results from non-clinical testing.

Based on the provided text, here's a breakdown of the information that aligns with your request, interpreting "acceptance criteria" as the successful demonstration of safety and effectiveness through the described clinical study and non-clinical testing:

Acceptance Criteria and Device Performance (Interpreted from Clinical Trial Endpoints and Non-Clinical Testing)

Study Details:

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

   • Test Set (Clinical Study):
     • Randomized Participants: 252 (126 active group, 126 sham group)
     • mITT (Modified Intent to Treat) analysis set (primary effectiveness analysis, excluding run-in and adhering to 1hr onset/2hr assessment): 202 participants (99 active, 103 sham).
     • PP (Per-protocol) analysis set: 197 participants (98 active, 99 sham).
     • ITT (Intent to Treat) analysis set: 203 participants (99 active, 104 sham).
   • Data Provenance: Prospective, multi-center, randomized, double-blind, sham-controlled study. The text does not explicitly state the country of origin for the clinical data; however, the contact information for the manufacturer is in Israel.

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

   • This device is not an AI/ML device that requires "ground truth" derived from expert image interpretation or pathology. Its effectiveness is measured by patient-reported outcomes (pain level, MBS relief, etc.) directly. Therefore, this question is not applicable in the context of this device's clinical study design. The "ground truth" for effectiveness is the patient's subjective experience reported at specific time points.

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

   • Not applicable as this is a patient-reported outcome study, not a study involving expert adjudication of findings (e.g., radiology reads).

4. 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 is not an AI/ML device assisting human readers. It's a therapeutic device for direct patient use.

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

   • Not applicable. This is a direct patient-use therapeutic device.

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

   • Outcomes Data: Patient-reported outcomes (pain scores, MBS status) at specified time points post-treatment. This is the "ground truth" for evaluating the device's effectiveness.

7. The sample size for the training set:

   • Not applicable. This is not an AI/ML device requiring a training set in the conventional sense. The device delivers electrical stimulation.

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

   • Not applicable. (See #7).

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