(38 days)
The Drug Relief v1 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.
The Drug Relief v1 is a wearable, battery-operated device that is designed to administer periodical low level electrical pulses to the ear over five days / 120 hours 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 provide the required stimulation energy for 120 hours. There are three stimulation electrode and one ground electrode which constitute of a titanium 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. The device is rectangular in shape and designed to fit comfortably on the neck. The biocompatible adhesive ensures that the device maintains contact with the skin during normal use. The adhesive fasteners ensure that the electrode needles and the entire device stay in place in a secure manner. 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 interpulse 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 describes the regulatory clearance of the "Drug Relief v1" device (K221231) by DyAnsys, Inc. It explicitly states that the device is substantially equivalent to a previously cleared predicate device, also named "Drug Relief v1" (K211971). The document primarily focuses on demonstrating this substantial equivalence rather than presenting an independent clinical study to prove the device meets specific performance criteria against a predefined ground truth in a clinical setting.
Therefore, many of the requested items related to clinical study design, expert involvement, and statistical measures of performance (like effect size with AI assistance) are not directly applicable or available in this regulatory submission. The "acceptance criteria" discussed are largely in the context of demonstrating equivalence to the predicate and safety/performance through non-clinical testing.
Here's an attempt to answer the questions based solely on the provided text, noting where information is not available:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of quantitative acceptance criteria and corresponding reported device performance against a clinical ground truth for the subject device (K221231). Instead, it focuses on demonstrating that the subject device has "equivalent performance specifications" and "identical fundamental technological and operational characteristics" to the predicate device (K211971). The "Performance Data" section discusses non-clinical testing.
Acceptance Criteria (Implicit - related to predicate equivalence and non-clinical performance):
| Acceptance Criteria (Implicit) | Reported Device Performance (K221231) |
|---|---|
| Intended Use / Indications for Use: Identical to predicate | Identical to predicate: "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." |
| Technological Characteristics: Equivalent to predicate | "identical intended use, indications for use, population, application of the device, environment of use" to predicate |
| Product Dimensions (mm x mm x mm): 38 * 21 * 10 | 38 * 21 * 10 |
| Mass (g): 8g (including battery) | 8g (including battery) |
| Frequency (Hz): 1 - 10 | 1 - 10 |
| Waveform: Biphasic with Rectangular Pulse | Biphasic with Rectangular Pulse |
| Battery Type: P13 Zinc Air batteries, non-rechargeable | P13 Zinc Air batteries, non-rechargeable |
| Battery Capacity: 310 mAh | 310 mAh |
| No. x Voltage (V): 3 x 1.4 V | 3 x 1.4 V |
| Pulse Width (ms): 0.980 | 0.980 |
| Duty Cycle: 2 hours ON / 1 min OFF | 2 hours ON / 1 min OFF |
| Typical Battery Operating Time (hours): 120 | 120 |
| Operating Temperature: 5 °C to 45 °C | 5 °C to 45 °C |
| Operating Humidity: 40% to 80% | 40% to 80% |
| Environmental Use: Clinics, Hospital, Home | Clinics, Hospital, Home |
| Sterilization of Electrodes: EtO Sterilization | EtO Sterilization |
| Re-use: Single use Device | Single use Device |
| Max Charge Density (µC / cm²) per needle: 67.16 @ 1 kΩ, 8.01 @ 10 kΩ | 67.16 @ 1 kΩ, 8.01 @ 10 kΩ |
| Max Average Power Density (W / cm²): 0.363 @ 1 kΩ, 0.0516 @ 10 kΩ | 0.363 @ 1 kΩ, 0.0516 @ 10 kΩ |
| Net Charge (µC per pulse): 0 (biphasic) | 0 (Due to biphasic nature of the waveform) |
| Software Controlled: Yes | Yes |
| Shelf Life: Increased from 6 months (predicate) to 12 months | 12 months (demonstrated through sterilization and non-clinical performance testing) |
| Biocompatibility: Pass | Subjected to biocompatibility testing (implied pass for clearance) |
| Electrical Safety (EMC and safety): Pass | Subjected to electrical safety (electromagnetic compatibility and safety) testing (implied pass for clearance) |
| Performance Bench Testing (120 hours continuous performance): Pass for pulse width, pulse duration, amplitude, current values | Functional test performed for 120 hours to monitor continuous performance. Captured pulse width, pulse duration, amplitude, and current values. Performance equivalent to predicate. |
| Software Validation: Pass | Subjected to software validation (implied pass for clearance) |
2. Sample size used for the test set and the data provenance
The document does not describe a clinical test set with human subjects or patient data. The "test set" discussed refers to non-clinical bench testing.
- Sample size: Not specified for individual bench tests, but implies a sufficient number of devices were tested for validation.
- Data provenance: Non-clinical bench testing data, likely conducted by DyAnsys, Inc.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. There was no clinical test set requiring expert ground truth establishment for diagnostic performance.
4. Adjudication method for the test set
Not applicable. No clinical test set and no expert adjudication were described.
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
Not applicable. This device is a nerve stimulator, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a nerve stimulator, not an algorithm. Its function is direct stimulation.
7. The type of ground truth used
For the non-clinical performance data, the "ground truth" was likely defined by engineering specifications and direct measurements against those specifications (e.g., measuring actual pulse width against the specified 0.980 ms). For establishing substantial equivalence, the "ground truth" was the characteristics, intended use, and indications for use of the predicate device (K211971).
8. The sample size for the training set
Not applicable. There is no mention of a training set for an algorithm in this submission.
9. How the ground truth for the training set was established
Not applicable. No training set was described.
§ 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.