(133 days)
The Drug Relief is a percutaneous nerve field stimulatory (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.
The Drug Relief™ is designed to aid in the treatment of opiate withdrawal symptoms by the method of electrical stimulation at the auricular stimulation points. The Drug Relief is a wearable, battery-operated device that is designed to administer periodical low-level electrical pulses to the ear over five days / 120 hours (2 hours ON/1 minute OFF) from the time of activation of the device. The electrical pulse from the device will be delivered to the branches of Cranial Nerves on the ear through a set of wire assembly and Stimulation needles. Three zinc air batteries with 1.4 V each provides the required stimulation energy for a maximum of 120 hours. There are three Stimulation electrodes and one ground electrode - which constitute of a needle and lead/ wire with the snap-fit ring. The stimulation needles are inserted at three specific points, which have the ability to stimulate the cranial nerves. The ground electrode is inserted at one specific point (constant in all treatments) which forms the functional earthing to the device. This constant current source guarantees equivalent stimulation energy regardless of the individual impedance of the skin. The stimulation pattern consists of rectangular pulses with differing inter-pulse intervals. A 3-pin connector is provided, which is used to check the output voltage of the device once it is activated and before applying to the patient with any one of the voltage measuring devices available in the market with the appropriate regulatory compliance.
The provided text is a 510(k) summary for the medical device "Drug Relief," a percutaneous nerve stimulator for opioid withdrawal. This document focuses on demonstrating substantial equivalence to a predicate device (NSS-2 BRIDGE) rather than presenting a clinical study with detailed acceptance criteria and performance metrics for the device itself.
Therefore, the information required to answer your request fully, particularly regarding specific acceptance criteria for "device performance" in a clinical setting, sample sizes for test sets, expert ground truth establishment, MRMC studies, and effect sizes, is not present in the provided document. The document primarily describes non-clinical performance and summarizes testing done to show equivalence to a predicate device.
However, I can extract and present the available information to address as many of your points as possible:
Summary of Acceptance Criteria and Device Performance (Based on Available Data)
Based on the provided 510(k) summary, the "acceptance criteria" appear to be primarily focused on demonstrating substantial equivalence to the predicate device (NSS-2 BRIDGE) through performance testing of the device's electrical characteristics and compliance with recognized standards, rather than clinical efficacy metrics.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Reported Device Performance / Comparison to Predicate |
|---|---|
| Electrical Performance | |
| Pulse Width | 0.980mSec (Equivalent to Predicate) |
| Operating Time | 120 hrs (5 days), 2 Hours ON (Periodically) (Equivalent to Predicate) |
| Frequency | Pulses with modulating frequency (1 Hz - 10 Hz) (Equivalent to Predicate) |
| Waveform | Rectangular pulse (Equivalent to Predicate) |
| Max Charge Density (per needle) | 65.67 @ 1K ohm; 7.96 @ 10K ohm (Compared to Predicate: 48.91 @ 1K ohm; 5.79 @ 10K ohm) |
| Max Average Power Density (per needle) | 0.346 @ 1K ohm; 0.0509 @ 10K ohm (Compared to Predicate: 0.2645 @ 1K ohm; 0.0371 @ 10K ohm) |
| Output Voltage Measurement Feasibility | 3-pin connector provided to measure output voltage. (Feasible on subject device, not on predicate) |
| Mechanical/Physical Equivalence | |
| Device Shape | Rectangle (Equivalent to Predicate) |
| Device Adhesive | Foam pad connected to adhesive – gel pad (Different from Tegaderm on predicate) |
| Needle Dimensions | 0.42 mm (widthlength) (Slightly different from predicate: 0.5mm width x 2mm length) |
| Wire Assembly | 4 units of wire with snap-fit ring (Different configuration than predicate) |
| Sterilization Method | EtO Sterilization (Different from Irradiation (Gamma) on predicate) |
| Shelf Life | 6 Months (Different from 12 months on predicate) |
| Compliance with Standards | |
| Electrical Safety | IEC 60601-1 (Compliance stated) |
| EMC | IEC 60601-1-2 (Compliance stated) |
| Biocompatibility | ISO 10993 (Compliance stated for several parts) |
| Sterilization | ISO 11135 and other related ISO standards (Compliance stated) |
| Functional Performance | |
| Continuous Performance | Monitored for 120 hours (Assumed to meet internal specifications for equivalence) |
| Effectiveness | "Validate the effectiveness of each unit" (Implied through functional test and comparison to predicate's "effectual output") |
Note: The document explicitly states that "These differences do not affect the safety and effectiveness of the device." This implies that the observed differences were deemed acceptable for substantial equivalence.
2. Sample Sizes Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not specify a sample size for a "test set" in the context of clinical performance or a human study. The "performance testing" described appears to be bench testing on the device units themselves.
- Data Provenance: Not applicable as no clinical study data for device performance or efficacy is presented. The comparison is against the specifications of a predicate device.
3. Number of Experts and Qualifications for Ground Truth
- Not applicable. The ground truth for this submission is based on the technical specifications and performance of a legally marketed predicate device, and compliance with recognized standards. There is no mention of expert-established ground truth for clinical performance.
4. Adjudication Method for the Test Set
- Not applicable. No clinical test set requiring adjudication is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No evidence of an MRMC study. The document focuses on device characteristics and substantial equivalence, not on human reader performance with or without AI assistance. The device itself is a stimulate, not an AI diagnostic tool.
6. Standalone (Algorithm Only) Performance
- Not applicable for an AI algorithm. This device is a percutaneous nerve stimulator. Its "performance" is based on its electrical output and how it delivers stimulation. The summary states that "The Drug Relief device and its components are subjected to performance testing to validate the effectiveness of each unit." This describes a standalone device performance test, but not an algorithm's performance.
7. Type of Ground Truth Used
- The "ground truth" for this 510(k) submission is primarily:
- Predicate Device Specifications: The technical and performance characteristics of the legally marketed predicate device (NSS-2 BRIDGE).
- Industry Standards: Compliance with recognized international standards (IEC, ISO) for medical devices, electrical safety, EMC, biocompatibility, and sterilization.
- Bench Testing Results: Measured electrical outputs and functional performance over time.
8. Sample Size for the Training Set
- Not applicable. This document describes a physical medical device, not a machine learning or AI model that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As above, there is no training set for this type of device.
§ 882.5896 Percutaneous nerve stimulator for substance use disorders.
(a)
Identification. A percutaneous nerve stimulator for substance use disorders is a device that stimulates nerves percutaneously to aid in the reduction of withdrawal symptoms associated with substance use disorders.(b)
Classification. Class II (special controls). The special controls for this device are:(1) The patient-contacting components of the device must be demonstrated to be biocompatible.
(2) Electromagnetic compatibility and electrical, mechanical, and thermal safety testing must be performed.
(3) Electrical performance testing of the device and electrodes must be conducted to validate the specified electrical output and duration of stimulation of the device.
(4) Software verification, validation, and hazard analysis must be performed.
(5) Sterility testing of the percutaneous components of the device must be performed.
(6) Shelf life testing must be performed to demonstrate continued sterility, package integrity, and device functionality over the specified shelf life.
(7) Labeling must include the following:
(i) A detailed summary of the device technical parameters;
(ii) A warning stating that the device is only for use on clean, intact skin;
(iii) Instructions for use, including placement of the device on the patient; and
(iv) A shelf life.