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510(k) Data Aggregation
(179 days)
Sparrow Therapy System
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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