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510(k) Data Aggregation
(125 days)
The Sparrow Ascent is a transcutaneous nerve field stimulator that is intended to be used in patients experiencing opioid withdrawal in conjunction with standard symptomatic medications and other therapies for opioid withdrawal symptoms under the supervision of trained clinical personnel.
The Sparrow Ascent is a transcutaneous auricular neurostimulation (tAN) system intended to provide non-invasive, transcutaneous stimulation of the nerves around the auricle (ear). The device is indicated as an aid in the reduction of opioid withdrawal symptoms in adult patients. The Sparrow Ascent is a battery operated, prescription device that delivers mild electrical stimulation to the nerves around the auricle (ear), which carry information to the central nervous system. The Sparrow Ascent is to be used in clinical environments (e.g., doctor's office, clinics, rehab centers, and hospitals) and/or at home. Users of the subject device include adults experiencing opioid withdrawal symptoms. Stimulation parameters (i.e., the strength of stimulation) are set by the user's clinician, and users can only adjust stimulation intensity (amplitude) at home. The system consists of three main components 1) a disposable Earpiece, 2) a Cable, and 3) the External Pulse Generator (EPG).
The provided FDA 510(k) clearance letter pertains to the Sparrow Ascent Transcutaneous Nerve Stimulator. The key aspect of this submission is a modification to the device's earpiece, specifically changing the stimulation site for the auricular branch of the vagus nerve (ABVN) from the cymba concha to the mastoid. The manufacturer aims to demonstrate that this change does not raise new questions of safety or effectiveness and that the modified device remains substantially equivalent to its predicate.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this 510(k) submission are primarily based on demonstrating functional equivalence of the new mastoid stimulation site to the previously cleared cymba concha site, specifically in terms of brain activation patterns, and overall safety and efficacy as compared to the predicate and reference devices.
| Acceptance Criteria | Reported Device Performance (from the document) |
|---|---|
| Brain Activation Equivalence: Spatial distribution of brain activity following mastoid stimulation is equivalent to cymba concha stimulation of the ABVN. | fMRI study showed activation maps for mastoid and cymba concha stimulation were significantly correlated (r = 0.61, p < 0.001). This indicates consistent central responses between the two stimulation sites and reliable stimulation-induced brain activation at the mastoid. |
| Similar Current Density: The output related to nerve activation for the subject device is similar to the reference device. | "[T]he current density (i.e., the output related to nerve activation) is similar between the subject and the reference devices and helps demonstrate equivalent effectiveness." (No specific numerical range provided in the summary, but stated as similar.) |
| Similar Power and Charge Density: The output related to stimulation site impact for the subject device is similar to the predicate and reference devices. | "[P]ower and charge density (i.e., the output related to the impact on the stimulation site) is similar between the subject, the predicate, and the reference devices, and helps demonstrate equivalent safety." (No specific numerical range provided in the summary, but stated as similar.) |
| Non-clinical Performance: Device operates as expected, meets product requirements, delivers safe and effective stimulation. | "Non-clinical performance testing verified that, like the predicate, the subject device operates as expected when used as intended, and both meets and satisfies product requirements." "concluded that the subject device can safely and effectively deliver transcutaneous peripheral nerve stimulation when used as intended." |
| Biocompatibility: Materials used remain biocompatible. | "In addition to testing performed to support the clearance of K230796 (e.g., biocompatibility), which remains applicable to the subject device..." (Implies original biocompatibility data sufficient and still valid). |
| Service Life: Demonstrated 3-year service life. | "extended service life testing was completed for the subject device to verify a service life of 3 years." |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set (Clinical Study): 24 healthy adults.
- Data Provenance: The document does not explicitly state the country of origin. It describes a prospective clinical study (fMRI study) conducted to compare brain activation patterns.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
- The document does not mention the use of external experts to establish ground truth for the fMRI study. The "ground truth" in this context is the objective physiological response (brain activation patterns) measured by the fMRI, which is interpreted by the study's researchers based on established neuroimaging analysis techniques (e.g., GLM).
- The qualifications of the researchers/analysts interpreting the fMRI data are not specified in the provided text.
4. Adjudication Method for the Test Set
- No adjudication method is described for the fMRI study results. The analysis methods (e.g., General Linear Modeling, one-sample t-tests, correlation analysis) are standard scientific approaches for interpreting fMRI data, not an adjudication process by multiple human observers.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No MRMC comparative effectiveness study was mentioned or performed. This submission is not evaluating human reader performance with or without AI assistance. Instead, it focuses on the equivalence of a technological characteristic (stimulation site) for a device that delivers nerve stimulation for opioid withdrawal, supported by objective physiological data (fMRI).
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Performance
- This is not an AI/Software as a Medical Device (SaMD) submission in the typical sense that would require standalone algorithm performance evaluation. The device is a hardware stimulator. The fMRI study evaluates the physiological effect of the stimulation, which is a standalone effect of the device itself, not an algorithm's diagnostic performance.
7. Type of Ground Truth Used
- The primary "ground truth" for the clinical study was objective physiological data (brain activation patterns as measured by fMRI). This data was then analyzed statistically to demonstrate equivalence.
8. Sample Size for the Training Set
- Not applicable / Not explicitly mentioned. This submission describes a modification to a hardware device and an fMRI study to demonstrate functional equivalence. There is no mention of an AI algorithm or a training set for such an algorithm. The 24 healthy adults were part of a test (or validation) set for the fMRI study, not a training set for an AI model.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As no AI algorithm training set is mentioned, the method for establishing its ground truth is not provided.
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