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The gammaCore Sapphire Non-invasive Vagus Nerve Stimulator is intended to provide noninvasive vagus nerve stimulation (nVNS) on the side of the neck. The gammaCore is indicated for the acute treatment of pain associated with episodic cluster headache in adult patients.

gammaCore Sapphire (gammaCore), like the predicate gammaCore-2 device, is a multi-use, hand-held, rechargeable, portable device consisting of a rechargeable battery, signal generating and amplifying electronics, with a slide control switch for user / operator control of the signal amplitude (relative range 0-40 continuous). Like gammaCore-2, gammaCore Sapphire:

• includes a charging station incorporated into the "clam shell" storage case connected to a power adapter to charge the device as necessary by the end user
• provides visible (light and display) and audible feedback (beep) 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
• . delivers 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.
• the number of remaining doses available in a 24-hour period is indicated on the . Display.

In comparison to the gammaCore-2 predicate K172270 (programmed by the manufacturer to deliver 24 doses per day up to a maximum of 99 days), gammaCore Sapphire can be programmed to deliver 24 doses per day for 10, 31, or 93 days and can be refilled / reloaded for additional 10, 31, or 93 day periods via an RFID card encoded and provided by electroCore or its authorized agent.

This document is a 510(k) Summary for the gammaCore Sapphire device, which is an external vagus nerve stimulator for headache. It focuses on demonstrating substantial equivalence to a predicate device (gammaCore-2) rather than presenting a novel device's performance data against acceptance criteria from a clinical study. Therefore, most of the requested information regarding acceptance criteria and a study proving the device meets them (especially in the context of clinical efficacy) is not present in this document.

The document highlights non-clinical testing to demonstrate that the modifications to the device are safe and effective, focusing on the RFID refill functionality.

Here's a breakdown of what can and cannot be extracted from the provided text:

Preamble: The document states, "The verification and validation activities, as identified by the risk analysis to ensure that the modified device is as safe and effective as the predicate device, have been completed and demonstrate that the predetermined acceptance criteria have been met." However, it does not provide the specific acceptance criteria or the detailed results of these verification and validation activities.

1. A table of acceptance criteria and the reported device performance

• Not explicitly provided. The document states that "predetermined acceptance criteria have been met" for non-clinical testing related to the modifications (RFID refill functionality), but it does not list these criteria or the performance results. The focus is on demonstrating that the modification doesn't negatively impact safety or effectiveness compared to the predicate, not on a new clinical performance study.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not applicable for a clinical test set. The document refers to "verification and validation activities" for non-clinical aspects (e.g., RFID functionality). No clinical test set data is provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable. This relates to clinical studies establishing ground truth, which were not conducted for this 510(k) submission regarding the device modifications.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable. This relates to clinical studies and ground truth establishment, which were not performed in this context.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• No, a MRMC comparative effectiveness study was not done. This is a modification to an existing device (gammaCore-2 to gammaCore Sapphire), and the submission states: "Clinical Data: Clinical studies were not required to validate the modifications in the gammaCore Sapphire." Therefore, there's no data on human reader improvement with AI assistance. The device is a stimulator, not an AI diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable. This device is a medical stimulator, not an algorithm, so "standalone performance" in the context of an algorithm is not relevant here. The device itself operates "standalone" in delivering stimulation.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not applicable. This relates to clinical studies. For the non-clinical "verification and validation activities," the "ground truth" would be engineering specifications and functional performance (e.g., does the RFID card successfully load the correct number of doses, is the Bluetooth feature accessible only by the manufacturer, etc.). No clinical ground truth on patient outcomes is presented for a new study.

8. The sample size for the training set

• Not applicable. This is for machine learning models. This document describes a medical device, not an AI algorithm.

9. How the ground truth for the training set was established

• Not applicable. This is for machine learning models.

Summary of what the document DOES state regarding studies:

• Nonclinical Testing: "The verification and validation activities, as identified by the risk analysis to ensure that the modified device is as safe and effective as the predicate device, have been completed and demonstrate that the predetermined acceptance criteria have been met." This implies internal engineering and functional testing, not clinical studies.
• Clinical Data: "Clinical studies were not required to validate the modifications in the gammaCore Sapphire." This is a key point, meaning no new clinical trials were conducted to support this 510(k) submission for the device modifications. The substantial equivalence relies on the predicate device's existing clinical evidence and the non-clinical testing of the modifications.

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The gammaCore-S Non-invasive Vagus Nerve Stimulator is intended to provide noninvasive vagus nerve stimulation (nVNS) on the side of the neck. The gammaCore -S device is indicated for the acute treatment of pain associated with episodic cluster headache and migraine headache in adult patients.

The gammaCore-S device (Catalog # 10009-40601 gammaCore-S, 31 day, 300 treatment device) is a hand-held portable device consisting of an outer plastic case, a battery, signal generating and amplifying electronics, LED and horn (indicate device status), and a pair of stainless steel skin contact surfaces (referred to as the "stimulation surfaces"). The device operating status is visible on a LCD display screen. Caps are provided to cover the stimulation surfaces when the device is not in use. Conductive electrode gel is provided for use with the device.

The gammaCore-S device produces a low voltage electric signal consisting of five 5000 Hz pulses that are repeated at a rate of 25 Hz. The waveform of the electric pulses is approximately a sine wave with a peak voltage limited to 24 Volts when placed on the skin and a maximum output current of 60mA. The signal is transmitted through the skin of the neck to the vagus nerve. The device allows up to 30 seconds for the operator to position and adjust the stimulation intensity, treatment is intended to be applied for 90 seconds (the treatment automatically stops 120 seconds after the device is powered on). Each device allows for multiple treatments (up to 300 2-minute treatments).

The document provided is a 510(k) Pre-market Notification from the FDA regarding the gammaCore-S device. This type of submission focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving safety and efficacy through a de novo clinical trial with defined acceptance criteria for individual performance metrics.

Therefore, the typical structure for outlining acceptance criteria and a study proving a device meets them (as would be seen for a new device requiring a full PMA or specific performance claims in a de novo classification) is not directly applicable here.

However, I can extract the relevant information from the provided text that describes the evidence used to support the expanded indication for migraine headaches, which implicitly serves the purpose of demonstrating that the device is "substantially equivalent" for this new indication.

Here's how the information aligns with your requested points, with an emphasis on how "substantial equivalence" is demonstrated rather than strict performance acceptance criteria for a novel device:

Device: gammaCore-S
Indication Expansion: Acute treatment of pain associated with migraine headache in adult patients.
Predicate Device: gammaCore-S (K171306), indicated for acute treatment of pain associated with episodic cluster headache.

1. Table of "Acceptance Criteria" (Implicit for Substantial Equivalence) and Reported Device Performance

As this is a 510(k) for an expanded indication of an identical device, the "acceptance criteria" are not reported as specific performance metrics (e.g., sensitivity, specificity, accuracy) like they would be for a diagnostic AI. Instead, the "acceptance criteria" are implicitly met by demonstrating safety and effectiveness for the new indication, showing superiority over sham, and confirming no new safety or effectiveness questions.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: The document does not explicitly state the total number of patients enrolled but describes it as a "multicenter" study.
• Data Provenance: The study was conducted across 10 expert headache centers in Italy from January 11, 2016, through March 31, 2017. It was a prospective, randomized, double-blind, parallel-group, sham-controlled clinical study.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This is not applicable in the context of this 510(k) submission. The "ground truth" here is the patient's subjective experience of pain and its resolution, as measured by standard clinical pain scales and reported outcomes in a sham-controlled trial. There are no "experts" establishing a "ground truth" in the sense of image annotation or disease diagnosis for an AI algorithm. The study was conducted by medical professionals at "expert headache centers."

4. Adjudication Method for the Test Set

Not explicitly stated regarding an adjudication method in the context of expert review. The study was a randomized, double-blind, parallel-group, sham-controlled study, which is the primary method of minimizing bias and establishing the effectiveness of the treatment itself. Blinding (patient and potentially assessor) serves a similar purpose to adjudication in ensuring unbiased outcome assessment.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC study was not conducted. This is not an AI-assisted diagnostic device where human readers interact with AI. It is a direct treatment device where patients use the device themselves.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Yes, in a sense. The "standalone" performance here refers to the device's ability to treat migraine pain when used by patients, as compared to a sham device. The clinical study directly assessed the device's therapeutic effect (i.e., its "performance") in real-world use by patients. There isn't an "algorithm" in the typical AI sense that would have separate standalone performance metrics (like AUC or accuracy) outside of its direct therapeutic application.

7. The Type of Ground Truth Used

The ground truth was based on patient-reported outcomes and clinical assessments of pain, pain intensity, and responder rates, as documented in a randomized controlled trial. This is directly tied to the primary and secondary endpoints:

• Primary Endpoint: Aborting the first treated attack at 30, 60, and 120 minutes.
• Secondary Endpoints: Mild or no pain at 120 minutes, changes in pain intensity from baseline, and ≥50% responder rates (pain-free and mild/pain-free) at 120 minutes.
• Safety Data: Adverse events reported.

8. The Sample Size for the Training Set

This is not applicable. The gammaCore-S is a direct treatment device, not an AI/ML algorithm that requires a "training set" in the computational sense. The clinical study served as a validation of the device's effectiveness for the expanded indication.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no "training set" in the AI/ML context for this device. Ground truth (patient outcomes) was established through direct measurement and reporting in a clinical trial setting using standard pain assessment methodologies.

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The gammaCore-S Non-invasive Vagus Nerve Stimulator is intended to provide noninvasive vagus nerve stimulation (nVNS) on the side of the neck. The gammaCore-S device is indicated for the acute treatment of pain associated with episodic cluster headache in adult patients.

gammaCore-S is a device that provides non-invasive Vagus Nerve Stimulation (nVNS) when applied to the side of the neck. This is a mild electrical stimulation of the vagus nerve, which runs through the neck and carries information to the central nervous system. Each stimulation with gammaCore-S lasts two minutes. The patient controls the stimulation strength.

This document is a 510(k) premarket notification for the gammaCore-S device, which is an external vagal nerve stimulator for headache. The document does not contain the information requested in the prompt regarding acceptance criteria and a study proving the device meets those criteria.

The document states:

• "Clinical Data: Clinical studies were not required to validate the modifications in the gammaCore-S."
• "The verification and validation activities, as identified by the risk analysis to ensure that the modified device is as safe and effective as the predicate device, have been completed and demonstrate that the predetermined acceptance criteria have been met."

Therefore, I cannot provide the requested information from this document because it explicitly states that clinical studies (which would typically contain such data) were not performed for this specific submission, as it relates to a modification of an already approved device.

To answer your request, a document detailing the clinical study or non-clinical performance data for the original gammaCore device (the predicate device) would be needed, or a document outlining the specific "predetermined acceptance criteria" and how they were met through non-clinical verification and validation activities for the gammaCore-S modifications.

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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."

2. Sample Size and Data Provenance

• ACT1 Study:
  • Total Enrolled: 150 patients with Cluster Headache (101 Episodic CH, 49 Chronic CH).
  • Modified Intent-to-Treat (mITT) Population: 60 subjects in nVNS group, 73 subjects in Sham group (total 133 for primary analysis after excluding those who didn't treat at least one CH attack).
  • Data Provenance: Multi-center clinical trial. Locations not specified beyond "multi-center." Implied prospective.
• ACT2 Study:
  • Total Enrolled: 102 patients with Cluster Headache (30 Episodic CH, 72 Chronic CH).
  • mITT Population: 48 subjects in nVNS group, 44 subjects in Sham group (for primary endpoint analysis, number of attacks treated was 495 for nVNS and 400 for Sham).
  • Data Provenance: Europe, "postmarket clinical study." Implied prospective.

3. Number of Experts and Qualifications for Ground Truth

• Not applicable for a therapeutic device clinical trial. Ground truth here is patient-reported pain scores (0-5 scale) and use of rescue medication, as well as clinician-assessed adverse events. It's not a diagnostic image interpretation scenario where expert readers establish ground truth.
• Diagnosis of Cluster Headache for study inclusion was based on ICHD-II criteria, established by medical professionals at the study sites.

4. Adjudication Method for the Test Set

• Not applicable. The "test set" here refers to the clinical trial participants. The primary outcomes (pain scores, rescue medication use) were assessed directly by the patients and recorded electronically or in diaries. Adverse events were reported by patients and assessed by study investigators/clinicians. No external adjudication panel like in imaging studies.

5. MRMC Comparative Effectiveness Study

• Not applicable. This device is a direct therapeutic intervention, not an AI assisting human readers, so an MRMC comparative effectiveness study is not relevant. The studies were direct comparisons of active device vs. sham in patients.

6. Standalone (Algorithm Only) Performance

• Not applicable. This is a hardware therapeutic device, not a standalone algorithm.

7. Type of Ground Truth Used

• Patient-reported outcomes and clinical assessments.
  • Pain Relief: Patient-reported pain intensity on a 5-point headache pain scale (0: No pain to 4: Very severe pain).
  • Rescue Medication Usage: Patient-reported.
  • Adverse Events: Patient-reported and clinically assessed by study investigators.
  • Diagnosis of CH: Based on ICHD-II criteria by qualified clinicians at study sites.

8. Sample Size for the Training Set

• Not applicable. This is not an AI/ML device, so there is no "training set" in the computational sense. The clinical studies were conducted to evaluate the device's efficacy and safety directly.

9. How the Ground Truth for the Training Set was Established

• Not applicable. (See point 8).

Summary regarding the context:

The provided document details the regulatory review of a physical medical device (vagus nerve stimulator) and its supporting clinical trials. The questions in the prompt are highly geared towards AI/ML medical devices, which typically involve algorithms processing data (e.g., images, physiological signals) for diagnostic or predictive purposes, where concepts like "test sets," "training sets," "expert ground truth," and "MRMC studies" are standard. Since the gammaCore device is a therapeutic device that is directly applied to the patient to stimulate a nerve, these AI/ML-specific concepts are largely irrelevant to its evaluation.

The FDA's "acceptance criteria" for this device were met by demonstrating a probable benefit for the acute treatment of episodic cluster headache (as shown by the statistically significant and clinically meaningful improvements in pain relief in the eCH cohort) and an acceptable risk profile (largely mild and transient adverse events, with no device-related serious adverse events).

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