(122 days)
The eNeura Inc. SpringTMS® is indicated for the acute and prophylactic treatment of migraine headache in adolescents (age 12 and older) and adults.
The SpringTMS® is a portable, hand-held device that is designed and intended to deliver 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 and prophylactic treatment of migraine headache. The device is designed for patient use where treatments are self-administered and can be delivered in a variety of settings including the home or office. The device is intended for prescription use only.
The provided text is a 510(k) summary for the eNeura SpringTMS device and solely focuses on demonstrating substantial equivalence to a previously cleared predicate device (K162797) for an expanded indication for use (adolescents aged 12 and older).
The key takeaway is that no new performance data or clinical studies were conducted for this specific 510(k) submission (K182976) because the subject device is technically identical to its predicate, and no changes in design or manufacturing that would affect functionality have been made. Therefore, the device relies on the performance data from the predicate device (K162797).
As such, the information requested in your prompt related to new acceptance criteria, device performance, sample sizes for test and training sets, ground truth establishment, expert adjudication, or MRMC studies for K182976 is not available in the provided document. The document explicitly states: "Thus, clinical testing was not conducted for this premarket notification, nor was required to support the safety and performance of the SpringTMS for the expanded Intended Use/Indications for Use population. Please refer to K162797 for further information regarding the prospective, single-arm, non-randomized Non-Significant Risk clinical study (ESPOUSE) conducted by eNeura using the SpringTMS device."
Therefore, I cannot populate the table or answer the specific questions based only on the provided text, as the document points to K162797 for details on the original study that established performance.
To answer your questions fully, the 510(k) summary for the predicate device, K162797, would need to be reviewed.
§ 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.