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510(k) Data Aggregation
(283 days)
The eNeura Therapeutics® Cerena™ Transcranial Magnetic Stimulator is indicated for the acute treatment of pain associated with migraine headache with aura.
The Neuralieve Cerena Transcranial Magnetic Stimulator (TMS) is a portable, hand-held, ACpowered device that delivers a brief pulse of magnetic energy at 0.9 Tesla to the back of the head to induce an electrical current in a portion of the brain (occipital cortex). This stimulation to the occipital cortex is intended to stop or lessen the effects of migraine headaches (with aura). The device is designed to be used in a home or office setting.
Here's a breakdown of the acceptance criteria and the study details for the Cerena Transcranial Magnetic Stimulator (TMS) device, as per the provided text:
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Cerena TMS device are based on its demonstrated safety and effectiveness in treating migraine headache with aura.
| Acceptance Criteria Category | Specific Criteria/Outcome | Reported Device Performance (Cerena vs. Sham) |
|---|---|---|
| Effectiveness - Primary | Proportion of subjects pain-free 2 hours post-treatment with baseline pain (pain score 1-3) | 37.74% for Cerena vs. 16.67% for Sham (p=0.0181) - Met (statistically significant difference in favor of Cerena) |
| Effectiveness - Secondary | Proportion of subjects pain-free 24 hours post-treatment with baseline pain (pain score 1-3) | 33.96% for Cerena vs. 10% for Sham (p=0.0025) - Met (supported device effectiveness) |
| Effectiveness - Associated Symptoms | Non-inferiority for proportion of subjects free of photophobia | Achieved (device does not worsen photophobia) - Met |
| Non-inferiority for proportion of subjects free of nausea | Not demonstrated - Not Met | |
| Non-inferiority for proportion of subjects free of phonophobia | Not demonstrated - Not Met | |
| Safety - Adverse Events | Low rate of device-related adverse events | 7 AEs in 5 subjects (9.43%) in Cerena group vs. 11 AEs in 7 subjects (11.67%) in sham group; majority were minor, no seizures reported - Met |
| Safety - Absence of Seizures | No seizures reported | No seizures reported - Met |
| Safety - Biocompatibility | Elements contacting patient assessed to be biocompatible | Justification of identical material with long safe use history for intact skin contact - Met |
| Safety - Electromagnetic Compatibility & Electrical Safety | Compliance with IEC 60601-1 and IEC 60601-1-2 | Tested and found in compliance - Met |
| Performance - Software | Verification, validation, and hazard analysis | Reviewed and documentation found adequate, consistent with "MODERATE" level of concern - Met |
| Performance - Magnetic Field Output | Characterization of magnetic pulse output and field map | Testing conducted to characterize device magnetic field output and pulse - Met |
| Performance - Sound Level | Sound level within OSHA safety limits | Testing performed to determine loudness and demonstrate compliance - Met |
The study successfully demonstrated the device's effectiveness in reducing migraine pain at 2 and 24 hours post-treatment compared to sham, and showed non-inferiority for photophobia. However, it did not demonstrate effectiveness in relieving nausea or phonophobia. Safety was also established with a low incidence of adverse events and no reported seizures.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set (Effectiveness Evaluation): 113 subjects
- 53 subjects in the Cerena group
- 60 subjects in the Sham group
- Data Provenance: The study was a prospective, randomized, double-blind, multi-center, sham-controlled trial. The country of origin is not explicitly stated, but it is a clinical trial conducted to support FDA de novo classification, implying it was likely conducted in the US or in compliance with US regulatory standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The ground truth for the clinical study was established by the subjects themselves, who reported their pain severity, associated migraine symptoms, and use of rescue medications at specified time points. Therefore, there were no external "experts" establishing ground truth in the traditional sense of image interpretation for this device. The diagnosis of migraine with aura was based on ICHD-II criteria, which would have been confirmed by medical professionals (physicians) at the study sites. The text does not specify the number or qualifications of these diagnosing physicians.
4. Adjudication Method for the Test Set
The study design was a prospective, randomized, double-blind, multi-center, sham-controlled trial. The "ground truth" (patient-reported outcomes) was self-reported by the subjects. There is no mention of an independent adjudication method (like 2+1 or 3+1 expert consensus) for the patient-reported efficacy endpoints. The double-blind nature (neither patient nor investigator knew treatment assignment) served as a control against bias.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically used for diagnostic devices involving human interpretation of images or other data. The Cerena TMS device is a therapeutic device, and its effectiveness was evaluated through direct patient outcomes (pain relief), not through human reader performance.
6. Standalone Performance Done
Yes, a standalone (algorithm only without human-in-the-loop performance) evaluation was done for the device's therapeutic effect. The clinical trial directly assessed the device's ability to reduce pain when used by subjects, without the intervention of an interpreting human expert at the point of treatment.
7. Type of Ground Truth Used
The primary ground truth used for effectiveness was patient-reported outcomes for pain severity, assessed on a scale of 0-3 (0=no pain, 3=severe pain), and for the presence of associated symptoms (photophobia, phonophobia, nausea). The initial diagnosis of migraine with aura was based on the International Classification of Headache Disorders, 2nd edition (ICHD-II) criteria, which serve as a clinically established ground truth for the patient population.
8. Sample Size for the Training Set
The document does not explicitly mention a separate "training set" in the context of device effectiveness, as would be common for AI/ML algorithms. The clinical trial of 201 subjects (102 Cerena, 99 sham) was the primary study for demonstrating safety and effectiveness. If "training set" refers to data used to inform the device's design or initial parameters, that information is not provided. For software, general verification, validation, and hazard analysis were performed, but not specifically in the context of an AI/ML training paradigm.
9. How the Ground Truth for the Training Set Was Established
As noted above, a distinct "training set" with established ground truth for an AI/ML algorithm is not described in this regulatory submission. The device's "training" in a broader sense would be its design, engineering, and iterative development process, informed by scientific understanding of TMS and migraine, rather than a data-driven machine learning training set with ground truth labels.
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