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510(k) Data Aggregation
(88 days)
Nerivio, FGD000075-4.7
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
| Acceptance Criteria (Inferred from Efficacy Endpoints) | Reported Device Performance (Adolescent Study) |
|---|---|
| Primary Safety Endpoint: | |
| Incidence of device-related adverse events | 2.2% (1 participant) |
| Device-related serious adverse events | 0% (None) |
| Withdrawal due to device-related adverse events | 0% (None) |
| Secondary Efficacy Endpoints: | |
| Proportion of participants achieving pain relief at 2 hours post-treatment (≥ mild to none, or severe/moderate to mild/none). | 71.8% (28/39 participants) |
| Proportion of participants achieving pain-free at 2 hours post-treatment. | 35.9% (14/39 participants) |
| Disappearance of associated symptoms (nausea/vomiting, photophobia, phonophobia) at 2 hours post-treatment. | Nausea: 54.5% (12/22) |
| Photophobia: 41.9% (13/31) | |
| Phonophobia: 40.0% (10/25) | |
| Exploratory Endpoints: | |
| Sustained pain relief at 24 hours. | 90.9% (20/22 participants) |
| Sustained pain-free at 24 hours. | 90.9% (10/11 participants) |
| Improvement in functional ability at 2 hours. | 69.7% (23/33 participants) |
| Improvement in functional ability at 24 hours. | 69.0% (20/29 participants) |
| Within-subject consistency of pain relief (in at least 50% of treated headaches). | 66.7% (26/39 participants) |
| Within-subject consistency of pain-free (in at least 50% of treated headaches). | 33.3% (13/39 participants) |
| Reduction in Pediatric Migraine Disability Assessment (PedMIDAS) score. | Average decrease of 18.6 ± 23.4 (from 37.1±30.4 at enrollment to 18.5±26.8 at end of treatment phase). |
| System Usability Scale (SUS) score | Mean SUS score: 85.1±12.7 (high acceptability) |
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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