(67 days)
The Allive is indicated for the prophylactic treatment of episodic migraine in patients 18 years of age or older.
The Allive 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 is a 510(k) summary for a medical device called "ALLIVE," a transcutaneous electrical nerve stimulator (TENS) intended for the prophylactic treatment of episodic migraine. It focuses on demonstrating substantial equivalence to a predicate device (CEFALY® K160237) rather than providing specific performance data against defined acceptance criteria from a clinical trial of the ALLIVE device itself.
Therefore, many of the requested details about acceptance criteria, performance data, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, and training data provenance cannot be extracted from this document, as the submission relies on non-clinical testing and a clinical evaluation report based on the predicate device's clinical data.
Specifically, the document states on page 12: "Although clinical performance data are required to demonstrate that the device is safe and effective as a treatment for headache in the indicated patient population on the special control according to clause b.6) of 21CFR882.5981, we consider that the subject device (Allive) is not applied with clause b.6) of 21CFR882.5981." and "Although there are not the clinical performance data of the subject device, we prepare the clinical evaluation report by using the collected clinical data of the predicate device."
Based on the provided text, here's what can be extracted and what cannot:
Acceptance Criteria and Study Proving Device Meets Criteria
The document does not detail specific acceptance criteria for the ALLIVE device's clinical performance, nor does it present a clinical study of the ALLIVE device itself. Instead, it argues for substantial equivalence based on technical comparisons and a review of the predicate device's clinical data.
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria for ALLIVE's Clinical Performance: Not explicitly stated in this document for the ALLIVE device. The submission relies on demonstrating substantial equivalence to a predicate device.
- Reported Device Performance: No clinical performance data specific to the ALLIVE device is reported in this document. The document states, "Although there are not the clinical performance data of the subject device, we prepare the clinical evaluation report by using the collected clinical data of the predicate device."
2. Sample sizes used for the test set and the data provenance
- Test Set Sample Size: Not applicable/not provided for a clinical study of the ALLIVE device. The "test set" here refers to non-clinical tests (biocompatibility, electrical safety, performance, usability, software).
- Data Provenance: Non-clinical test data was generated for the ALLIVE device by the manufacturer (Nu Eyne Co., Ltd., Korea). The clinical evaluation references "collected clinical data of the predicate device," but specific provenance (e.g., country of origin, retrospective/prospective) for that predicate data is not detailed in this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This information pertains to medical imaging or diagnostics, where expert review establishes ground truth. The ALLIVE device is a therapeutic TENS device. Its performance is evaluated through technical specifications and indirectly through the predicate device's clinical outcomes.
4. Adjudication method for the test set
- Not applicable. As above, this typically applies to expert review processes for diagnostic accuracy, not physical device performance or therapeutic outcomes.
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
- No. This is not an AI/imaging device. No MRMC study was conducted or referenced for the ALLIVE device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a TENS unit, not an algorithm. Its performance is inherent to its physical operation and effect on the patient.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the non-clinical performance tests (electrical, biocompatibility, etc.), the "ground truth" is adherence to established international standards (e.g., IEC 60601-1, ISO 10993-5/10) and manufacturer's SOPs, verified through laboratory testing.
- For the clinical evaluation, the ground truth would have been derived from the outcomes data of the predicate device's clinical trials, as summarized in the Clinical Evaluation Report, which is not provided in detail here beyond its existence.
8. The sample size for the training set
- Not applicable. This device is not an AI algorithm that requires a "training set."
9. How the ground truth for the training set was established
- Not applicable. See point 8.
§ 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.