(546 days)
The gammaCore Non-invasive Vagus Nerve Stimulator is intended to provide non-invasive vagus nerve stimulation (nVNS) on the side of the neck. The gammaCore device is indicated for the acute treatment of pain associated with episodic cluster headache in adult patients.
The gammaCore Non-invasive Vagus Nerve Stimulator (hereafter referenced as "gammaCore device") is a hand-held portable device (Figure 1) consisting of an outer plastic case, a battery, signal generating and amplifying electronics, a thumbwheel to power on the device and control stimulation intensity (range 0-5 continuous, relative), LED and horn (indicate device status), and a pair of stainless steel skin contact surfaces (referred to as the "stimulation surfaces"). Electrode conductive gel is applied to the electrode surfaces prior to placement on the skin of the neck over the pathway of the vagus nerve.
The provided text describes clinical trials for the gammaCore Non-invasive Vagus Nerve Stimulator, but it is not an AI/ML-driven medical device. The focus of the acceptance criteria and the "study that proves the device meets the acceptance criteria" in the prompt implies an AI/ML context, which is not present in the provided document.
Therefore, many of the requested elements regarding sample size for test sets, data provenance, expert-established ground truth, adjudication methods, MRMC studies, standalone algorithm performance, and training set details are not applicable to this non-AI/ML device.
However, I can extract and present the information available regarding the device's performance in clinical trials relative to its intended use and any implied "acceptance criteria" based on the FDA's decision to grant De Novo classification.
Here's an attempt to structure the available information as requested, while acknowledging the limitations due to the non-AI/ML nature of the device:
Acceptance Criteria and Device Performance for gammaCore Non-invasive Vagus Nerve Stimulator (Non-AI/ML Device)
The FDA granted De Novo classification for the gammaCore Non-invasive Vagus Nerve Stimulator based on a clinical comparison of probable risks and benefits to health. The "acceptance criteria" are implied by the clinical endpoints studied and the FDA's determination of probable benefit outweighing probable risks for the indicated population.
1. Table of Acceptance Criteria (Implied) and Reported Device Performance
Since this is a non-AI/ML device and not a diagnostic/AI model, the acceptance criteria are not in terms of traditional metrics like sensitivity, specificity, AUC. Instead, for a therapeutic device, acceptance is based on demonstrating a clinically meaningful benefit and an acceptable safety profile. The primary clinical endpoints in the studies serve as the de facto "performance metrics."
| Acceptance Criteria (Implied by Clinical Endpoints) | Reported Device Performance (Episodic Cluster Headache Cohort) |
|---|---|
| Efficacy: Clinically meaningful improvement in acute pain relief. | ACT1 Study (Primary Endpoint): |
- Response rate (pain 0 or 1 at 15 min, no rescue med at 60 min): 34.2% (nVNS) vs. 10.6% (Sham) (P=0.008, statistically significant in post-hoc subgroup analysis).
- Sustained treatment response rate (pain 0 or 1 at 60 min, no rescue med at 60 min): 34.2% (nVNS) vs. 10.6% (Sham).
- Subjects who were responders at 15 min for ≥50% of treated attacks: 34.2% (nVNS) vs. 14.9% (Sham) (P=0.04).
- Change in duration of attacks from baseline: -14.4 minutes (nVNS) vs. 16.3 minutes (Sham) (P=0.03). |
| | ACT2 Study (Primary Endpoint): - Attacks pain-free at 15 min (no rescue med at 30 min): 47.5% (nVNS) vs. 6.2% (Sham) (P
§ 882.5892 External vagal nerve stimulator for headache.
(a)
Identification. An external vagal nerve stimulator for headache is a prescription device used to apply an electrical current to a patient's vagus nerve through electrodes placed on the skin for the treatment of headache.(b)
Classification. Class II (special controls). The special controls for this device are:(1) 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 shall be fully characterized through non-clinical performance testing.(2) Software verification, validation, and hazard analysis shall be performed.
(3) Biocompatibility evaluation of the patient-contacting components of the device shall be performed.
(4) The device shall be tested for electrical, thermal, and mechanical safety, and for electromagnetic compatibility (EMC).
(5) The labeling must include:
(i) Instructions for proper use of the device, including placement of the device on the patient; and
(ii) Instructions on care and cleaning of the device.