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510(k) Data Aggregation
(125 days)
Spark Biomedical, Inc.
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 |
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(90 days)
Spark Biomedical, Inc.
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 on and/or 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 on and/or 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 at home. The system consists of three main components 1) a disposable Earpiece, 2) a Cable, and 3) the External Pulse Generator (EPG).
Here's a breakdown of the acceptance criteria and the study details for the Sparrow Ascent device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The FDA clearance letter does not explicitly state pre-defined acceptance criteria in terms of specific performance metrics (like sensitivity, specificity, or % reduction). Instead, the clinical study's primary efficacy endpoint served as the performance criterion for effectiveness.
| Acceptance Criteria (Primary Efficacy Endpoint) | Reported Device Performance |
|---|---|
| Successful mean percent change in COWS score (defined as a ≥15% reduction) from baseline, 60 minutes after the start of active tAN therapy. | Successfully met. At the conclusion of Day 1 (120 minutes), 93.8% of participants had a clinically significant reduction in COWS score (≥15% reduction). This increased to 100% on Day 2 and was sustained across Day 5. |
| Safety Endpoints: Prevalence of all adverse events (AEs), serious adverse events (SAEs), adverse device events (ADEs), serious adverse device effects (SADEs), unanticipated serious adverse device effects (USADEs), and device deficiencies. | In 14 patients, who experienced a total of 943.6 hours of skin contact, there were no instances of adverse tissue reactions reported. The overall clinical study demonstrated acceptable safety profile, though specific AE rates are not detailed in this summary. |
| Biocompatibility: Demonstrated compliance with ISO 10993 standards and supportive information from the RESTORE clinical study. | Compliance with ISO 10993 series for cytotoxicity, skin sensitization, and irritation. RESTORE clinical study further supported biocompatibility with no adverse tissue reactions in 943.6 hours of skin contact among 14 patients. |
| Software Verification: Compliance with IEC 62304 and ISO 14971. | Explicitly states compliance with IEC 62304 and ISO 14971. |
| Electromagnetic Compatibility and Electrical Safety: Compliance with ANSI/AAMI 60601-1, 60601-1-11, and 60601-1-2. | Explicitly states compliance with ANSI/AAMI 60601-1, 60601-1-11, and 60601-1-2. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Clinical Study): 23 participants were enrolled, and 20 received tAN therapy.
- Data Provenance: The study was conducted at two US sites, making the data provenance United States and prospective (as it was a designed clinical study for this purpose).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not mention the use of experts to establish a "ground truth" for the test set in the traditional sense of image interpretation or diagnosis. The ground truth for effectiveness was based on the Clinical Opiate Withdrawal Scale (COWS) scores, which are a standardized and objective measure of opioid withdrawal symptoms. These scores are typically assessed by trained clinical personnel. The document does not specify the number or qualifications of the personnel who administered the COWS scores in this study.
4. Adjudication Method for the Test Set
The document does not describe a traditional adjudication method for the test set data (e.g., 2+1, 3+1). The primary and secondary endpoints were based on changes in COWS scores, which are quantitative measures. The study was a double-blind, randomized, controlled study, which inherently helps to reduce bias in the assessment of outcomes.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The device is a direct treatment device (nerve stimulator), not an AI-powered diagnostic tool for interpretation by human readers. Therefore, the concept of "how much human readers improve with AI vs without AI assistance" is not applicable here.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
The device itself is a "standalone" therapeutic device (a transcutaneous nerve stimulator) that delivers stimulation. It does not involve an algorithm providing outputs for human interpretation. Its performance is assessed directly on patient outcomes (reduction in COWS scores). The "algorithm" in this context refers to the device's operational parameters, not an AI diagnostic algorithm. The study described assesses the device's direct therapeutic effectiveness.
7. The Type of Ground Truth Used
The ground truth for the effectiveness study was clinical symptom scores (COWS scores), which are a standardized and objective measure of opioid withdrawal severity. Safety ground truth was based on reported adverse events (AEs).
8. The Sample Size for the Training Set
The document refers to the clinical study of the predicate device (K201873) and "leverag[ing] prior clinical testing" for effectiveness, but it primarily details the study performed for the current device (Sparrow Ascent). It's not clear if there was a separate "training set" in the context of machine learning, as this is a medical device, not an AI algorithm. The study described appears to be the primary clinical evidence for the device's effectiveness.
9. How the Ground Truth for the Training Set Was Established
As this is a medical device and not an AI algorithm, the concept of a "training set" and establishing "ground truth for the training set" in the machine learning sense is not directly applicable. The effectiveness was established through a prospective, double-blind, randomized, controlled multi-center clinical study evaluating the impact of the nerve stimulator on COWS scores, as described in section 7 above. The summary also references the prior clearance of the predicate device (NSS-2 Bridge, DEN170018) which would have undergone its own clinical studies to establish similar effectiveness.
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(179 days)
Spark Biomedical, Inc.
The Sparrow 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 Therapy System is a non-invasive, battery-operated, prescription device designed to transcutaneously stimulate nerves on and/or around the auricle 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 system includes three components: Earpiece, Patient Controller, and the Clinician Application. Sparrow is used in clinical environments (i.e., rehab centers and hospitals) and at home. Users of the subject device include experiencing opioid withdrawal symptoms.
Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Key Metric | Acceptance Criteria (Implied) | Reported Device Performance (All Subjects, N=26) | Reported Device Performance (Study Completers, N=14) |
|---|---|---|---|
| COWS score percent reduction at 60 minutes | ≥15% reduction from baseline | 50.4% | 50.5% |
| Percentage of patients who passed the naloxone challenge | Not explicitly stated as acceptance criteria, but reported. | 10/26 (38.5%) | 10/14 (71.4%) |
| Percentage of patients completing the study | Not applicable (outcome of study, not a performance metric) | 14/26 (53.8%) | --- |
| Percentage of patients transitioning to MAT | Not explicitly stated as acceptance criteria, but reported. | 12/26 (46.2%) | 7/14 (50.0%) |
| Prevalence of adverse events (AEs) | Acceptable safety profile (no explicit numeric threshold) | Documented and considered in benefit-risk analysis | Documented and considered in benefit-risk analysis |
| Prevalence of serious adverse events (SAEs) | Acceptable safety profile (no explicit numeric threshold) | Documented and considered in benefit-risk analysis | Documented and considered in benefit-risk analysis |
| Prevalence of adverse device events (ADEs) | Acceptable safety profile (no explicit numeric threshold) | Documented and considered in benefit-risk analysis | Documented and considered in benefit-risk analysis |
| Prevalence of serious adverse device effects (SADEs) | Acceptable safety profile (no explicit numeric threshold) | Documented and considered in benefit-risk analysis | Documented and considered in benefit-risk analysis |
| Prevalence of unanticipated serious adverse device effects (USADEs) | Acceptable safety profile (no explicit numeric threshold) | Documented and considered in benefit-risk analysis | Documented and considered in benefit-risk analysis |
| Prevalence of device deficiencies | Acceptable safety profile (no explicit numeric threshold) | Documented and considered in benefit-risk analysis | Documented and considered in benefit-risk analysis |
Primary Effectiveness Endpoint and Acceptance Criteria:
The primary effectiveness endpoint of the clinical study was a successful mean percent change in COWS score (defined as a ≥15% reduction) from baseline to 60 minutes after the start of active tAN therapy. The reported performance of 50.4% reduction for all subjects and 50.5% for study completers demonstrates that the device met this primary acceptance criterion.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: 26 participants (N=26) were enrolled in the study. 14 completed the study.
- Data Provenance: Prospective. The study was conducted at one US site. The text indicates it was a "double-blind, randomized, prospective study."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
The document does not explicitly state the number or qualifications of experts used to establish the ground truth (COWS scores) for the test set. COWS (Clinical Opiate Withdrawal Scale) is a standardized tool, typically administered by trained clinical personnel. The study was conducted "under the supervision of trained clinical personnel," implying these professionals would have been responsible for assessing COWS scores.
4. Adjudication Method for the Test Set:
The document does not explicitly detail an adjudication method for the COWS scores or other assessments used in the test set. Given that COWS is a clinical assessment, it's typically performed directly by clinicians during the study visits.
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 multi-reader multi-case (MRMC) comparative effectiveness study was not done. The device, the Sparrow Therapy System, is a transcutaneous nerve stimulator, not an AI-based diagnostic or assistive software that involves human readers interpreting images or data. Therefore, the concept of human readers improving with AI assistance is not applicable to this device type.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
The Sparrow Therapy System is a physical medical device (nerve stimulator) that delivers therapy. It operates independently as intended once activated, but its use is "under the supervision of trained clinical personnel." It is not an algorithm or software-only device where "standalone" performance in the absence of human input would be a relevant metric in the same way it would be for an AI diagnostic tool. However, the effectiveness study (reduction in COWS scores) represents the "standalone" performance of the device in its intended clinical setting in achieving the therapeutic effect.
7. The Type of Ground Truth Used:
The primary ground truth used for effectiveness was the Clinical Opiate Withdrawal Scale (COWS) score. This is a clinical assessment tool used to quantify the severity of opioid withdrawal symptoms.
8. The Sample Size for the Training Set:
The document does not mention a separate "training set" in the context of device development or clinical validation for the Sparrow Therapy System. This suggests that the clinical study described (with N=26 participants) served as the primary means of evaluating the device's effectiveness. For medical devices, particularly physical ones, a "training set" in the sense of machine learning algorithms is often not applicable unless the device incorporates complex adaptive algorithms. The device's design and stimulation parameters were likely developed through engineering and preclinical testing.
9. How the Ground Truth for the Training Set Was Established:
As no specific "training set" is mentioned in the context of clinical data for the device, this question is not directly applicable. If the device incorporates an adaptive algorithm, the methods for establishing ground truth for any data used to train such an algorithm would need to be described, but this information is not present in the provided text.
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