(87 days)
THE ELEXIR is indicated for the acute treatment of migraine (program 1) and the prophylactic treatment of episodic migraine (Program 2) in patients 18 years of age or older
The ELEXIR device is a transcutaneous electrical nerve stimulator (TENS) that is applied to the forehead using a self-adhesive electrode positioned over the upper branches of the trigeminal verve bilaterally. It is intended to stimulate the upper branches of the trigeminal verve in order to reduce the frequency of migraine attack.
The provided text does not contain specific acceptance criteria or performance data for the ELEXIR device itself. Instead, it states that the device's safety and effectiveness are supported by non-clinical (biocompatibility, electrical safety, performance, usability, software) tests and a clinical evaluation report based on data from the predicate device, CEFALY® Dual. The document claims that the ELEXIR device is "not applied with clause b.6) of 21CFR882.5981," which likely refers to a requirement for clinical performance data for devices to treat headache. However, it then states that a clinical evaluation report was prepared using collected clinical data of the predicate device, concluding that the subject device is safe and effective.
Therefore, I cannot provide a table of acceptance criteria and reported device performance from the provided text, nor can I answer questions 2, 3, 4, 5, 6, 7, 8, and 9 for the subject device (ELEXIR). The document explicitly mentions that clinical performance data for the subject device are not available and that its safety and effectiveness are inferred from the predicate device's data.
Here's a summary of what can be extracted:
- Acceptance Criteria for Non-Clinical Tests: The acceptance criteria for the non-clinical tests are implicitly the successful fulfillment of the listed international and FDA guidance standards.
- Study Proving Device Meets Acceptance Criteria (Non-Clinical): Various non-clinical tests were performed.
1. A table of acceptance criteria and the reported device performance
The document does not provide specific numerical acceptance criteria or performance results for the ELEXIR device in a table format. It states that non-clinical tests were performed in accordance with various standards, implying that meeting these standards constitutes the acceptance criteria.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not provided for ELEXIR. For the clinical evaluation, data was collected from the predicate device. No details on its sample size or provenance are given for the predicate device's clinical data, other than it was "collected clinical data."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable, as no direct clinical study data for the subject device (ELEXIR) is presented. The clinical evaluation relies on data from the predicate device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no direct clinical study data for the subject device (ELEXIR) is presented.
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 transcutaneous electrical nerve stimulator, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a transcutaneous electrical nerve stimulator.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the clinical evaluation, the safety and effectiveness for headache treatment were established using "collected clinical data" of the predicate device. The specific type of "ground truth" (e.g., patient-reported outcomes, physician diagnosis, etc.) for the predicate device's data is not detailed in this document.
8. The sample size for the training set
Not applicable, as this is not an AI/ML device that requires a training set. If referring to the predicate device's clinical data used for evaluation, no sample size is provided.
9. How the ground truth for the training set was established
Not applicable, as this is not an AI/ML device. If referring to the predicate device's clinical data, the method for establishing ground truth is not specified.
§ 882.5891 Transcutaneous electrical nerve stimulator to treat headache.
(a)
Identification. A transcutaneous electrical nerve stimulator to treat headache is a device used to apply an electrical current to a patient's cranium through electrodes placed on the skin.(b)
Classification. Class II (special controls). The special controls for this device are:(1) The patient-contacting components of the device must be demonstrated to be biocompatible.
(2) Appropriate analysis/testing must validate electromagnetic compatibility and electrical, mechanical, and thermal safety.
(3) The technical parameters of the device, including waveform, output modes, maximum output voltage and current (with 500, 2,000, and 10,000 ohm loads), pulse duration, frequency, net charge (µC) per pulse, maximum phase charge at 500 ohms, maximum current density (mA/cm
2 , r.m.s.), maximum average current (mA), maximum average power density (W/cm2 ), and the type of impedance monitoring system must be fully characterized.(4) Electrical performance, adhesive integrity, shelf life, reusability, and current distribution testing of the electrodes must be conducted.
(5) Appropriate software verification, validation, and hazard analysis must be performed.
(6) Clinical performance data must demonstrate that the device is safe and effective as a treatment for headache in the indicated patient population.
(7) Labeling must include the following:
(i) Appropriate contraindications such as not for use in subjects with an implanted metallic or electronic device in the head, a cardiac pacemaker, or an implanted or wearable defibrillator.
(ii) Appropriate warnings such as not to apply the device on the neck or chest, not to use the device in the presence of electronic monitoring equipment, not to use in the bath or shower, not to use while sleeping, not to use while driving, not to use while operating machinery.
(iii) Appropriate precautions such as the long-term effects of chronic use of the device are unknown.
(iv) A summary of the expected risks and benefits of using the device.
(v) A summary of the clinical performance data, including information on the patient population for which the device has and has not been demonstrated to be effective, and any adverse events and complications.
(vi) Information on how the device operates and the typical sensations experienced during treatment.
(vii) A detailed summary of the device technical parameters.
(viii) An expiration date/shelf life for the electrodes and the number of times they can be reused.
(ix) Disposal instructions.