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The Relivion® transcutaneous electrical nerve stimulator is indicated for the acute treatment of migraine with or without aura in patients 18 years of age or older. It is a prescription device to be self-used at home.

The modified Relivion® is an external non-invasive neurostimulator designed for transcutaneous electrical nerve stimulation. The modified Relivion® headset integrates three pairs of output electrodes which come in contact with the subject's scalp at the forehead and occiput. The electrodes deliver the stimulation pulses produced by the headset's stimulation unit to the subject's scalp. The frontal electrodes stimulate the trigeminal (supraorbital and supratrochlear) nerve branches and the posterior electrodes stimulate the greater occipital nerve branches.

The modified Relivion® includes single-use replaceable electrode pads that are positioned on-top of the electrodes prior to treatment and are wetted by the user before use, in order to provide proper conductivity between the electrodes and the scalp.

The modified Relivion® is powered by a rechargeable battery and the headset incorporates an onboard user interface that enables the user to activate/deactivate the device and to adjust the stimulation intensity. Upon treatment activation, the treatment automatically runs and ends after 60 minutes or alternatively, the user can stop the treatment when desired.

The modified Relivion® can communicate via a low energy Bluetooth link with the modified Relivion®'s dedicated mobile application on the patient's smartphone. The modified Relivion®'s mobile application is optional, and it is used by the patient to display the device status and provide indications and alerts. Additionally, the modified Relivion® mobile application also enables the patient to report their migraine headache status.

The main modification introduced in the Relivion® Device compared to the cleared predicate device (K203419) is an added optional Physician Interface that enables physicians to remotely follow-up on the patient's migraine attacks status and the treatments they performed using the Relivion device, based on the data transferred to it via the modified mobile application.

Both the modified Relivion®'s mobile application (for patients) and added physician interface (for physicians) are referred together as the optional "Patient Management Interface" (PMI) of the modified Relivion® Device.

This document is a 510(k) premarket notification from Neurolief Ltd. for their Relivion® device, seeking clearance for a modified version. The primary modification is the addition of an optional Physician Interface to the existing mobile application. This is not a study proving a device meets acceptance criteria, but rather a document seeking clearance by demonstrating substantial equivalence to a previously cleared predicate device based on bench testing and software validation.

Therefore, the requested information, specifically regarding acceptance criteria and performance data for a clinical study, cannot be extracted from this document, as it outlines bench testing and software validation for modifications to an already cleared device, not a new clinical study with specific performance acceptance criteria for human efficacy.

The document explicitly states: "Because the modification to the device impacted only the software, no further testing was required." This indicates that no new clinical study was performed.

The "Performance Data" section solely refers to:

• Bench testing for the modifications (output parameters meeting specifications).
• Software testing for the Patient Management Interface (PMI) and Physician Interface (verification and validation, cybersecurity).

It does not provide details of a clinical study, acceptance criteria for clinical performance, sample sizes for a test set or training set, expert adjudication, MRMC studies, or specific ground truth methodologies for clinical outcomes.

Therefore, I am unable to fulfill the request for this specific information based on the provided text.

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The Relivion® transcutaneous electrical nerve stimulator is indicated for the acute treatment of migraine with or without aura in patients 18 years of age or older. It is a prescription device to be self-used at home.

The Relivion® is an external non-invasive neurostimulator designed for transcutaneous electrical nerve stimulation. The Relivion® headset integrates three pairs of output electrodes which come in contact with the subject's scalp at the forehead and occiput. The electrodes deliver the stimulation pulses produced by the headset's stimulation unit to the subject's scalp. The frontal electrodes stimulate the trigeminal (supraorbital and supratrochlear) nerve branches and the posterior electrodes stimulate the greater occipital nerve branches.

The Relivion® includes single-use replaceable electrode pads that are positioned on-top of the electrodes prior to treatment and are wetted by the user before use, in order to provide proper conductivity between the electrodes and the scalp.

The Relivion® is powered by a rechargeable battery and the headset incorporates an on-board user interface that enables the user to activate/deactivate the device and to adjust the stimulation intensity. Upon treatment activation, the treatment automatically runs and ends after 60 minutes or alternatively, the user can stop the treatment when desired.

The Relivion® can communicate via a low energy Bluetooth link with the Relivion® dedicated mobile application on the user's smartphone. The Relivion® mobile application is optional and it is used to display the device status and provide indications and alerts.

The provided document is a 510(k) premarket notification for the Relivion® device, a transcutaneous electrical nerve stimulator for the acute treatment of migraine. It details the device's characteristics, performance data, and comparison to a predicate device (Cefaly® Acute).

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Relivion® device, as derived from the RIME study (the pivotal clinical trial for the commercial version of the device), focused on the efficacy of pain relief.

Study Details Proving Acceptance Criteria are Met

The primary study cited to demonstrate the Relivion® device's efficacy and safety for its intended use (the commercial version for which clearance is sought) is the RIME study.

1. Sample Size Used for the Test Set and Data Provenance:

   • Test Set Sample Size: 131 patients (109 females and 22 males).
   • Data Provenance: Patients were enrolled at 12 sites in the US and Israel. This indicates both prospective and multi-country data collection.

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

   • The document describes a sham-controlled clinical trial where patients' self-reported pain levels and other migraine-related symptoms (e.g., Migraine Burden Scale, MBS) constitute a significant portion of the "ground truth."
   • While the study involved clinical sites and likely medical professionals overseeing the trial, the "ground truth" for the primary and secondary endpoints is based on patient-reported outcomes.
   • No specific number or qualifications of experts establishing "ground truth" in terms of independent adjudication of outcomes are mentioned beyond what is inherent in the clinical trial design (e.g., investigators at the sites). The blinding assessment was done by reviewing subjects' feelings about the treatment, but not explicitly stated as "expert" ground truth for the clinical endpoints themselves.

3. Adjudication Method for the Test Set:

   • The study was a prospective, randomized, parallel-group, sham-controlled clinical trial.
   • To maintain blinding, "measures included concealed allocation, use of an identical sham device and the same treatment protocol in all the study stages: device training, self-practice period and treatment period."
   • "Additionally, sham stimulation was set to a level well above the sensory threshold to further enhance subject's blinding."
   • A "blinding assessment" was conducted, revealing that subjects' feelings regarding the treatment received did not influence the study outcome.
   • The results were analyzed based on statistical comparison between the active and sham groups. This is a standard clinical trial design for efficacy measurement, and the "adjudication" is inherent in the blinded, randomized, controlled nature of the study and statistical analysis of patient-reported outcomes. There is no mention of a separate expert adjudication panel for individual case outcomes in the typical sense (e.g., 2+1 radiologist review).

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

   • No. This device is a direct-to-patient neuromodulation device for migraine treatment. The clinical evaluation focuses on patient outcomes (pain relief, pain freedom, MBS improvement) measured from the device's application, either active or sham, compared to baseline and between groups. It does not involve human readers interpreting images or data, hence an MRMC study is not applicable.

5. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

   • The device functions as a standalone treatment device. Its performance is measured by its direct effect on migraine symptoms as reported by patients, not as an algorithm assisting a human in a diagnostic or interpretive task. The clinical study (RIME) inherently assesses the "standalone" performance of the device in a real-world use case (self-used at home).

6. The Type of Ground Truth Used:

   • The ground truth used for evaluating the device's performance is patient-reported outcomes (PROs), specifically:
     • Migraine headache pain levels (from severe/moderate/mild to no pain at 2 hours).
     • Pain freedom (at 1 and 2 hours).
     • Improvement in Migraine Burden Scale (MBS) (at 1 and 2 hours).
     • Reduction in overall pain level (at 1 hour).
     • Absence of rescue medication use within the specified timeframe.
   • In the context of the study design, these PROs serve as the clinical "ground truth" for assessing the device's efficacy.

7. The Sample Size for the Training Set:

   • The document describes the Relivion® as a neurostimulator, not a machine learning or AI model that requires a "training set" in the computational sense.
   • Therefore, there is no "training set" of data for an algorithm. The clinical studies (OS-TNS, SP-301, and RIME) are clinical trials to evaluate the device's safety and efficacy in human subjects.

8. How the Ground Truth for the Training Set Was Established:

   • As there is no computational "training set" for an algorithm, this question is not applicable. The device's mechanism of action is transcutaneous electrical nerve stimulation, which is a physical intervention, not a data-driven model. The "ground truth" for previous clinical testing (OS-TNS and SP-301 studies) would have been established through similar patient-reported outcomes, following standard clinical trial methodologies and ethical guidelines (GCP, institutional ethics committees).

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