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510(k) Data Aggregation
(243 days)
The NSS-2 BRIDGE is a percutaneous nerve field stimulator (PNFS) system, that can be used as an aid to reduce the symptoms of opioid withdrawal, through application to branches of Cranial Nerves V, VII, IX and X, and the occipital nerves identified by transillumination.
NSS-2 BRIDGE is a device that electrically stimulates branches of Cranial Nerves V. VII. IX and X, and the occipital nerves identified by transillumination through percutaneous electrodes to aid in the reduction of opioid withdrawal symptoms. The device consists of (1) a percutaneous nerve field stimulator (PNFS; Figure 1), (2) a multi-pin wire harness percutaneous electrode array (Figure 2), and (3) a pen light for use in the transillumination technique that aids in positioning of the percutaneous electrodes (Figure 3).
Acceptance Criteria and Study for NSS-2 BRIDGE
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance/Study Findings |
|---|---|---|
| Effectiveness | The device, when used as an aid to reduce symptoms of opioid withdrawal, should demonstrate a clinically significant reduction in opioid withdrawal symptoms. A COWS score change of 15% for a given individual is considered clinically significant. | Clinical Study Results: A single-arm, open label, multi-center retrospective study (n=73) demonstrated a significant reduction in COWS scores: - Baseline: Mean COWS score of 20.1 (±6.1) - 20 minutes post-placement: Mean COWS score reduced to 7.5 (±5.9), a 62.7% reduction (p<0.001 vs baseline) - 60 minutes post-placement: Mean COWS score reduced to 3.1 (±3.4), an 84.6% reduction (p<0.001 vs baseline) - Day 5 post-placement (subset n=33): Mean COWS score of 0.6, a 97.1% reduction (p<0.001 vs baseline) - Overall: 100% (73/73) subjects had a reduction in COWS scores by 30 minutes with a minimum decrease of at least 31%. At 60 minutes, 78% (57/73) had withdrawal scores of ≤3. - MAT Transition: 88.8% (64/73) successfully transitioned to medically assisted therapy (MAT). |
| Safety | - Biocompatibility for patient-contacting materials. - Compliance with electrical, mechanical, and thermal safety standards. - Sterility of percutaneous components. - Absence of significant adverse events. | - Biocompatibility: Biocompatibility information was leveraged from the previously cleared EAD device (K140530) for most patient-contacting materials (fixation plasters, foam adhesive, metal of electrode arrays). No additional testing was required for changes in electrode configuration or housing material due to the non-patient-contacting nature of the housing with the adhesive. - Electrical/Mechanical/Thermal Safety: Conformed to IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-10 (leveraged from K140530). - Sterility: Sterilization Validation conducted using VDMAX25 method according to ISO 11137-2:2007 demonstrated SAL of 10^-6. Fulfilled requirements of ISO 11737-2:2009. - Adverse Events (Clinical Study): No adverse events were recorded in any subject (n=73) during the entire time of neurostimulation. - Adverse Events (Retrospective Chart Review): A separate retrospective chart review of 1207 PNFS devices (19312 punctures) across 6 US sites for various indications reported: bleeding (n=11), pain (n=2), dermatitis (n=11). All resolved spontaneously upon device removal. No infections noted for this device. |
| Performance (Bench) | - Verification of temporal characteristics and amplitude of pulse train. - Verification of pulse train duty cycle. - Verification of maximum operating time (120 hours). | - Additional electrical bench testing (leveraged from K140530) was performed under 1kΩ resistance. - Successfully verified new output duty cycle and pulse characteristics for NSS-2 BRIDGE. - Successfully verified temporal characteristics and amplitude of the pulse train. - Successfully verified that the device does not exceed maximum operating time of 120 hours. |
| Software | - Software verification and validation (for "Minor" level of concern). | - Software information leveraged from K140530. - Additional software verification successfully performed for NSS-2 BRIDGE to verify the new output duty cycle performed as specified (2 hours on, 1 minute off, repeating over 120 hours). Software was considered "Minor" level of concern. |
| Shelf Life/Packaging | - Continued sterility, package integrity, and device functionality over specified shelf life. | - Shelf life and sterility information leveraged from K140530 as no changes to sterilization method, shelf life, or packaging. - Validation of packaging system performed per ISO 11607-1:2009 and ASTM F1980-07:2011 (accelerated aging). |
| Use Environment | - Splash-proof, not watertight. | - Stated limitation: "The appliance is splash-proof but not watertight. When showering, the device must not be allowed to come into direct contact with water." (This is a design characteristic, implicitly met if labeling reflects it). |
2. Sample Size for Test Set and Data Provenance
- Sample Size: 73 patients.
- Data Provenance: Retrospective study. Data was collected from participating outpatient drug treatment clinics located across five US states: St. Louis, MO (27 patients), Liberty, IN (13), Florence, KY (12), Anchorage, AK (9), Rising Sun, IN (6), Richmond, IN (2), Dayton, OH (2), and Indianapolis, IN (2).
3. Number of Experts and Qualifications for Ground Truth
The study does not mention the use of experts to establish ground truth for the test set. The ground truth for opioid withdrawal symptoms was established through the Clinical Opioid Withdrawal Scale (COWS) scores, which were recorded as part of the treatment protocol in the participating clinics. These scores are obtained by medical professionals (e.g., clinicians, nurses), but the study does not specify their exact qualifications or the number of individuals involved in scoring each patient. The COWS is a standardized, subjective assessment tool.
4. Adjudication Method for the Test Set
The study does not mention any specific adjudication method for the COWS scores in the test set. Scores were "recorded" and "extracted from the medical chart," implying a single assessment per time point per patient.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. The study was a single-arm, open-label retrospective study, evaluating the device's effect without a direct comparison to human readers' performance with and without AI assistance or a control group receiving no intervention/placebo in the same manner.
6. Standalone (Algorithm Only) Performance Study
No, a standalone (algorithm only) performance study was not done. The device (NSS-2 BRIDGE) is a hardware device that electrically stimulates nerves; it does not involve an AI algorithm to analyze data or provide a diagnosis. Its performance is directly tied to its physical application and electrical stimulation.
7. Type of Ground Truth Used
The ground truth used was expert assessment using a standardized clinical scale, specifically the Clinical Opioid Withdrawal Scale (COWS). The COWS is a widely recognized tool for assessing the severity of opioid withdrawal symptoms, typically administered by trained healthcare professionals. While not "pathology" or "outcomes data" in the direct sense of a biological marker, it represents a clinical judgment based on observable signs and reported symptoms.
8. Sample Size for the Training Set
The document does not define a "training set" in the context of this device's effectiveness study. The NSS-2 BRIDGE is a medical device, not an AI/machine learning algorithm requiring a distinct training phase with a dedicated dataset. The clinical study described served as the primary evidence for its efficacy for regulatory purposes.
9. How the Ground Truth for the Training Set Was Established
As there was no distinct "training set" for an AI/ML algorithm, this question is not applicable. The device's mechanism of action is electrical stimulation, not a learned algorithm.
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