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510(k) Data Aggregation
(127 days)
The eNeura Therapeutics® Spring TMS® is indicated for the acute treatment of pain associated with migraine headache with aura.
The SpringTMS® is a portable, hand-held device that delivers a brief single 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 called the occipital cortex to stop or lessen the effects of migraine headaches. Since a single pulse of magnetic stimulation is emitted, this method of stimulation is called single pulse transcranial magnetic stimulation or sTMS. The SpringTMS is indicated for the acute treatment of pain associated with migraine headache with aura. The device is designed for patient use where treatments are selfadministered and can be delivered in a variety of settings including the home or office. The device is intended for prescription use only.
The provided document is a 510(k) premarket notification for the SpringTMS device. It describes the device, its intended use, and argues for its substantial equivalence to a predicate device (Cerena™ Transcranial Magnetic Stimulator).
However, it does not contain acceptance criteria related to clinical performance (e.g., diagnostic accuracy, treatment efficacy percentages) for the device itself. Instead, the "acceptance criteria" discussed are primarily related to engineering, safety, and performance bench testing to demonstrate substantial equivalence to a previously approved device.
Therefore, the requested information components related to clinical studies, ground truth, expert adjudication, sample sizes for test/training sets, and MRMC studies are largely not present in the provided text.
Here's a breakdown of what can be extracted and what is missing based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
| Testing Type | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Performance Bench Testing | ||
| Magnetic Pulse Characteristics vs. Time | Within specification for magnetic pulse shape (identical to predicate) | "Both devices have the same specification for magnetic pulse shape and both tested within specification. No new issues of safety or efficacy have been raised. The measured rate of change of the magnetic field is substantially equivalent." |
| Magnetic Pulse Field Map | Substantially equivalent to predicate device's field map, raising no new safety/efficacy issues. | "No new issues of safety or efficacy have been raised. The Magnetic Pulse Field Maps for the SpringTMS and the predicate device are substantially equivalent." |
| Location of 5 Gauss Line | Substantially equivalent to predicate device's location of the 5 Gauss line, raising no new safety/efficacy issues. | "No new issues of safety or efficacy have been raised. The location of the 5 Gauss line for the SpringTMS and the predicate are substantially equivalent." |
| Software Verification Validation Testing | Meeting all requirements of the Software Requirements Specification (SRS), with safety/performance specifications substantially equivalent to predicate's SRS. | "SpringTMS Software met all requirements of the SRS. No new issues of safety or efficacy have been raised. All safety and performance specifications for the SpringTMS SRS are substantially equivalent to those in the SRS for the predicate." |
| Electromagnetic Compatibility & Electrical Safety | Meeting acceptance criteria of specified standards (IEC 60601-1:2005, IEC 60601-1-2:2007), raising no new safety/efficacy issues. | "The SpringTMS and the predicate device met all acceptance criteria. No new issues of safety or efficacy have been raised. Therefore the SpringTMS is substantially equivalent to the predicate." |
| Clinical Performance (e.g., treatment efficacy) | Not specified in this document. The document states the device has the "identical" indication for use as the predicate, meaning its clinical effectiveness is assumed to be equivalent based on the predicate's prior approval. | No new clinical performance data is presented in this document to establish efficacy percentages or outcomes for the SpringTMS. It relies on the substantial equivalence to the predicate device, which was presumably justified by its own clinical data at the time of its approval (K130556). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable as the testing described is primarily bench testing and software verification, not clinical performance testing on a patient sample. No "test set" of patient data is mentioned.
- Data Provenance: Not applicable. The testing is internal engineering and software verification.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable. No clinical "ground truth" or expert adjudication for performance criteria is described.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. No clinical test set requiring adjudication is described.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
- MRMC Study: No, an MRMC comparative effectiveness study was not conducted or described in this document. The submission focuses on substantial equivalence to a predicate device based on technological characteristics and bench testing, not on comparative clinical efficacy against human readers or other treatments.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
- Standalone Performance: Not applicable. This is a medical device (Transcranial Magnetic Stimulator), not an AI algorithm. Its "performance" refers to its physical output (magnetic pulses) and safety characteristics, not an algorithmic assessment of data.
7. The Type of Ground Truth Used
- Type of Ground Truth: For the technical and safety testing (magnetic pulse characteristics, software requirements, electrical safety), the "ground truth" involved adherence to established engineering specifications and international standards (e.g., IEC 60601-1, IEC 60601-1-2) or demonstrating equivalence to the predicate device's measured characteristics.
- There is no clinical ground truth (e.g., pathology, outcomes data, expert consensus on patient response) discussed for the SpringTMS itself in this document, as the submission relies on the predicate's known efficacy.
8. The Sample Size for the Training Set
- Sample Size: Not applicable. This refers to training data for an algorithm. The SpringTMS is a hardware device for treatment, not an AI/algorithm that is "trained."
9. How the Ground Truth for the Training Set Was Established
- Ground Truth Establishment: Not applicable for the same reasons as #8.
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(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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