(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.
§ 882.5808 Transcranial magnetic stimulator for headache.
(a)
Identification. A transcranial magnetic stimulator device for headache is a device that delivers brief duration, rapidly alternating, or pulsed, magnetic fields that are externally directed at spatially discrete regions of the brain to induce electrical currents for the treatment of headache.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Appropriate analysis/testing must demonstrate electromagnetic compatibility, electrical safety, and thermal safety.
(2) Appropriate verification, validation, and hazard analysis must be performed on the device software and firmware.
(3) The elements of the device that contact the patient must be assessed to be biocompatible.
(4) Non-clinical testing data must demonstrate that the device performs as intended under anticipated conditions of use. This includes full characterization of the magnetic pulse output and resulting magnetic field map. This also includes characterization of the sound level of the device during use.
(5) Clinical testing must demonstrate that the device is safe and effective for treating headache in the indicated patient population.
(6) The physician and patient labeling must include the following:
(i) A summary of the clinical performance testing, including any adverse events and complications.
(ii) The intended use population in terms of the types of headaches appropriate for use with the device.
(iii) Information on how to report adverse events and device malfunctions.
(iv) A diagram or picture depicting the proper placement of the device on the user.