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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):

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.

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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 designed to be used as an aid to reduce opioid withdrawal symptoms by the method of cranial electrical stimulation at the auricular stimulation points. 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 atimulation electrode 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 and a duty cycle of 2 hours ON/1 minute OFF. 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 Drug Relief v1 device and its substantial equivalence to a predicate device, Drug Relief (K173861). The document primarily focuses on demonstrating that the new device has similar performance specifications and safety characteristics to the previously cleared predicate.

Here's an analysis of the provided information concerning acceptance criteria and studies:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of predetermined acceptance criteria with corresponding performance results. Instead, it relies on demonstrating that the "Drug Relief v1 has equivalent performance specifications when compared to the predicate device." This is a common approach for 510(k) submissions, where the new device's performance is compared to a legally marketed predicate rather than against absolute, pre-defined acceptance metrics for efficacy in a clinical setting.

However, the core of the performance evaluation for this type of device, as indicated, revolves around:

• Electrical Safety Parameters: Max Charge Density (µC/cm²) and Max Average Power Density (W/cm²).
• Functional Performance: Pulse width, duty cycle, amplitude, and current values over the intended operating time (120 hours).
• Biocompatibility: Ensuring materials are safe for patient contact.
• Software Verification and Validation: Confirming the software functions as intended.
• Sterilization: Achieving a defined sterility assurance level (SAL).

The document states that the reported device performance for the Drug Relief v1 shows these characteristics are "identical or near identical" to the predicate device. Specifically, the electrical output parameters are presented in "Table 13.3.2 Comparison of Technical System Characteristics" (pages 6-7).

2. Sample Size Used for the Test Set and Data Provenance

The document describes nonclinical testing, including "performance bench testing" and "electrical safety (electromagnetic compatibility and safety)" for the Drug Relief v1 device (page 7). It also mentions "software verification and validation" and "biocompatibility testing."

• Sample Size: The specific sample sizes for these tests (e.g., how many devices were tested for electrical safety or how many batches for sterilization) are not explicitly stated in the provided text.
• Data Provenance: The studies are described as nonclinical (bench testing) and likely conducted by the manufacturer (DyAnsys, Inc.). There is no mention of clinical data, human subjects, country of origin related to human data, or retrospective/prospective study design, as this submission is based on demonstrating substantial equivalence through technical and performance comparisons to a predicate device.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable and not provided because the evaluation presented is based on nonclinical testing (bench tests, electrical safety, etc.) and direct comparison to a predicate device's technical specifications. There is no "ground truth" derived from expert interpretation of clinical data in this document.

4. Adjudication Method for the Test Set

This is not applicable and not provided as the submission does not involve clinical studies with human readers or diagnostic interpretations requiring adjudication.

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

This is not applicable and not provided. The Drug Relief v1 is a percutaneous nerve stimulator, not an AI-based diagnostic imaging or analysis device. There is no mention of human readers, AI assistance, or MRMC studies.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

This is not applicable and not provided. The device is a nerve stimulator, not an algorithm, and the submission does not refer to AI or algorithmic performance evaluation.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

As this is a nonclinical performance and electrical safety submission, the "ground truth" refers to established engineering standards, electrical measurement protocols, and material science specifications. For example:

• Electrical Safety: Standards like those for current leakage, output parameters, and EMC.
• Biocompatibility: ISO standards for biological evaluation of medical devices.
• Sterilization: ISO standards for sterilization processes and sterility assurance.
• Functional Performance: The established specifications of the predicate device (Drug Relief K173861) serve as the benchmark for "equivalent performance."

8. The Sample Size for the Training Set

This is not applicable and not provided, as there is no mention of an algorithm or AI model requiring a training set in this submission.

9. How the Ground Truth for the Training Set was Established

This is not applicable and not provided, for the same reason as point 8.

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