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510(k) Data Aggregation
(88 days)
gammaCore Sapphire (non-invasive vagus nerve stimulator) is intended to provide non-invasive vagus nerve stimulation (nVNS) on the side of the neck. gammaCore is indicated for:
- · Adjunctive use for the preventive treatment of cluster headache in adult patients.
- · The acute treatment of pain associated with episodic cluster headache in adult patients.
- · The acute treatment of pain associated with migraine headache in adult patients.
The gammaCore Sapphire (gammaCore) is a multiuse, handheld, rechargeable, portable device consisting of a rechargeable battery and signal-generating and amplifying electronics, with a slide control switch for user/operator control of the signal amplitude (relative range, 0-40 continuous).
The gammaCore Sapphire:
- . Includes a charging station incorporated into the "clam shell" storage case connected to a power adapter for charging of the device as necessary by the end user.
- . Provides visible (light and display) and audible (beep) feedback regarding device and stimulation status.
- . Allows for multiple stimulations or doses; each stimulation or dose lasts 120 seconds, after which the device automatically turns off unless turned off earlier by the user/operator. Note: One dose is defined as one stimulation cycle lasting 120 seconds (2 minutes).
- . Delivers up to a fixed number of doses within a 24-hour period; once the maximum daily number of doses has been reached, the device will not deliver any more doses until the following 24-hour period.
- Indicates on the display the number of remaining doses available in a 24-hour period. ●
The provided documentation describes the gammaCore Sapphire (non-invasive vagus nerve stimulator), which is indicated for:
- Adjunctive use for the preventive treatment of cluster headache in adult patients.
- The acute treatment of pain associated with episodic cluster headache in adult patients.
- The acute treatment of pain associated with migraine headache in adult patients.
The information primarily focuses on demonstrating substantial equivalence to predicate devices rather than defining specific acceptance criteria for performance benchmarks against a gold standard for a diagnostic AI device. However, based on the clinical study presented, we can infer a primary efficacy outcome as an "acceptance criteria" and the reported device performance from that study.
Here's the breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred from Primary Endpoint) | Reported Device Performance (SoC + nVNS group vs. Control) |
|---|---|
| Significantly greater reduction in the mean number of Cluster Headache (CH) attacks per week. | Study Outcome: Mean reduction of 5.9 CH attacks per week for SoC + nVNS vs. 2.1 for Control. |
| Therapeutic Gain: 3.9 fewer attacks per week (95% CI: 0.5, 7.2; P=0.02). | |
| Higher 50% responder rates (proportion of subjects with ≥50% reduction in CH attacks). | Study Outcome: 40% responder rate for SoC + nVNS vs. 8.3% for Control (P<0.001). |
| Reduction in the use of abortive medications (Sumatriptan and Oxygen). | Study Outcome: Reduction observed in SoC + nVNS group from baseline (7.2 to 5.9 for Sumatriptan, 17.3 to 13.9 for Oxygen). Control group showed smaller or no reduction. |
| Clinically meaningful improvements in Quality of Life (QoL) outcomes (EQ-5D-3L Index, VAS, HIT-6 scores). | Study Outcome: Statistically significant improvements in several QoL measures for SoC + nVNS group compared to control (e.g., EQ-5D-3L Index score change of 0.113 vs -0.047; P=0.011). |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set (Clinical Study):
- Sample Size:
- Safety Population: 48 subjects in the nVNS + SoC group and 49 subjects in the Control group (total 97 subjects).
- mITT (modified intent-to-treat) Population: Numbers vary slightly depending on the specific QoL measure evaluated (e.g., 35-37 for SoC + nVNS, 40-46 for Control).
- Data Provenance:
- Country of Origin: Europe (multicenter, across 10 sites).
- Retrospective or Prospective: Prospective, randomized, controlled study.
- Sample Size:
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The device is a therapeutic device (vagus nerve stimulator) for headache treatment, not a diagnostic AI device requiring expert-established ground truth for image or data interpretation. The "ground truth" in this context refers to the clinical outcomes and patient-reported data (e.g., number of headache attacks, abortive medication use, quality of life scores) observed and recorded during a clinical trial. These outcomes were assessed by clinical study personnel (e.g., investigators, nurses) and self-reported by patients, rather than adjudicated by independent experts in the same way a diagnostic image would be.
4. Adjudication Method for the Test Set
As this is a therapeutic device trial, standard clinical trial methodology was used. There isn't a stated adjudication method in the sense of multiple experts reviewing and reaching a consensus on individual patient outcomes or data points being "adjudicated." The outcomes (headache frequency, medication use, QoL scores) were derived from patient diaries and questionnaires, and then statistically analyzed. The study was described as "randomized, controlled," implying proper blinding where feasible to minimize bias in outcome reporting, though explicit details on blinding of outcome assessors weren't provided.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
No, an MRMC comparative effectiveness study was not done. This type of study is typically performed to evaluate the diagnostic accuracy of imaging or AI algorithms when interpreted by multiple human readers, often with and without AI assistance. This device is a therapeutic device, not an interpretative diagnostic tool.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
The gammaCore Sapphire is a physical medical device (vagus nerve stimulator) that directly delivers therapy, not a standalone algorithm. Therefore, "standalone" algorithm performance without human interaction is not applicable. The device's performance is intrinsically tied to its use by a human patient.
7. The Type of Ground Truth Used
The "ground truth" for evaluating the efficacy of the gammaCore Sapphire (for the preventive treatment of cluster headache) was based on patient-reported clinical outcomes and objective measures of disease activity, including:
- Change in mean number of cluster headache attacks per week.
- 50% responder rates (proportion of patients experiencing a ≥50% reduction in attacks).
- Reduction in abortive medication use (sumatriptan and oxygen).
- Quality of life outcomes (EQ-5D-3L Index score, EQ-5D-3L VAS score, HIT-6 score).
8. The Sample Size for the Training Set
The provided documentation does not detail a "training set" in the context of an AI algorithm. The device's efficacy was established through a clinical trial in which the treatment group received the active device. There is no mention of a pre-market "training set" for an AI component.
9. How the Ground Truth for the Training Set Was Established
Since there is no mention of an AI algorithm "training set," this question is not applicable based on the provided text. The device's efficacy was established through the clinical study described, where the "ground truth" was the observed clinical improvement in the patient population.
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