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The Sparrow Ascent 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 Ascent is a transcutaneous auricular neurostimulation (tAN) system intended to provide non-invasive, transcutaneous stimulation of the nerves around the auricle (ear). The device is indicated as an aid in the reduction of opioid withdrawal symptoms in adult patients. The Sparrow Ascent is a battery operated, prescription device that delivers mild electrical stimulation to the nerves around the auricle (ear), which carry information to the central nervous system. The Sparrow Ascent is to be used in clinical environments (e.g., doctor's office, clinics, rehab centers, and hospitals) and/or at home. Users of the subject device include adults experiencing opioid withdrawal symptoms. Stimulation parameters (i.e., the strength of stimulation) are set by the user's clinician, and users can only adjust stimulation intensity (amplitude) at home. The system consists of three main components 1) a disposable Earpiece, 2) a Cable, and 3) the External Pulse Generator (EPG).

The provided FDA 510(k) clearance letter pertains to the Sparrow Ascent Transcutaneous Nerve Stimulator. The key aspect of this submission is a modification to the device's earpiece, specifically changing the stimulation site for the auricular branch of the vagus nerve (ABVN) from the cymba concha to the mastoid. The manufacturer aims to demonstrate that this change does not raise new questions of safety or effectiveness and that the modified device remains substantially equivalent to its predicate.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this 510(k) submission are primarily based on demonstrating functional equivalence of the new mastoid stimulation site to the previously cleared cymba concha site, specifically in terms of brain activation patterns, and overall safety and efficacy as compared to the predicate and reference devices.

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The NET Device is a transcutaneous alternating current stimulator (ACS) 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 NET Device is a non-invasive, battery-powered, portable, prescription device designed to provide bilateral, transcranial, transcutaneous, alternating current stimulation (tACS) to be used in patients experiencing opioid withdrawal under the supervision of trained clinical personnel. The system is comprised of one component (the NET Device), accessories (patient leads, electrodes, USB cable), and software (the clinician application). NET Devices, patient leads, and USB cables are reusable. No reprocessing, sterilization, maintenance, or recalibration is required. Electrodes are for single patient use only. The NET Device is used in professional healthcare facility environments (e.g., rehab centers and hospitals). If benefit is not established within 60 minutes of use, discontinue use and seek other methods of treatment.

The provided document is a 510(k) summary for the NET Device, which is a transcutaneous alternating current stimulator intended for patients experiencing opioid withdrawal. The study described focuses on demonstrating the substantial equivalence of the NET Device to its predicate device, the Sparrow Therapy System.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance

The document doesn't explicitly state "acceptance criteria" for performance in a tabular format. Instead, it defines a clinically meaningful decline in COWS (Clinical Opiate Withdrawal Scale) score as ≥15% reduction from baseline to 1-hour after the start of active NET stimulation, and then reports the device's performance against this benchmark. Safety is assessed by the absence of device-related adverse events and comparison of risk profiles to the predicate device.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: 108 participants.
  • Active group: 53 participants
  • Sham group: 55 participants
• Data Provenance:
  • Study Type: Prospective, randomized, parallel-group, sham-controlled, superiority study.
  • Country of Origin: One US site.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

The "ground truth" in this study is the Clinical Opiate Withdrawal Scale (COWS) score. The document states that COWS scores were measured, but it does not specify the number of experts or their qualifications for assessing these scores. It's implied that trained clinical personnel (nurses, physicians) administered the COWS assessments as standard practice for such a study, but no specific details are provided.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

The document does not describe any specific adjudication method for the COWS scores in the test set. It is standard for COWS assessments to be performed by a single trained clinician at each time point, so a multi-reader adjudication method would be unusual for this type of scale.

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

An MRMC comparative effectiveness study was not done. This study is not evaluating an AI algorithm assisting human readers, but rather a direct therapeutic device (transcutaneous alternating current stimulator) and its effect on opioid withdrawal symptoms, compared to a sham control. Therefore, there is no discussion of human readers or AI assistance.

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

This question is not applicable. The NET Device is a therapeutic medical device, not an AI algorithm. Its performance is directly observed in patients, not as an algorithm-only output.

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

The primary "ground truth" used for effectiveness was the Clinical Opiate Withdrawal Scale (COWS) score, which is a standardized, clinician-rated assessment of opioid withdrawal severity. This is a form of expert assessment by trained clinical personnel.
Secondary outcomes included:

• Cumulative inpatient MOUD (Medications for Opioid Use Disorder) utilization.
• Illicit opioid use during the outpatient phase (measured by oral fluid drug screen or timeline follow-back interview).
• Presence of device-related adverse events for safety.

8. The sample size for the training set

This question is not applicable. The NET Device is a physical medical device, not a machine learning model, so there is no "training set" in the context of AI/ML. The clinical study described is a pivotal trial to demonstrate safety and effectiveness for regulatory clearance, not for training an algorithm.

9. How the ground truth for the training set was established

This question is not applicable, as there is no training set for an AI/ML algorithm.

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The Sparrow Ascent 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 Ascent is a transcutaneous auricular neurostimulation (tAN) system intended to provide non-invasive, transcutaneous stimulation of the nerves on and/or around the auricle (ear). The device is indicated as an aid in the reduction of opioid withdrawal symptoms in adult patients. The Sparrow Ascent is a battery operated, prescription device that delivers mild electrical stimulation to the nerves on and/or around the auricle (ear), which carry information to the central nervous system. The Sparrow Ascent is to be used in clinical environments (e.g., doctor's office, clinics, rehab centers, and hospitals) and/or at home. Users of the subject device include adults experiencing opioid withdrawal symptoms. Stimulation parameters (i.e., the strength of stimulation) are set by the user's clinician, and users can only adjust stimulation intensity at home. The system consists of three main components 1) a disposable Earpiece, 2) a Cable, and 3) the External Pulse Generator (EPG).

Here's a breakdown of the acceptance criteria and the study details for the Sparrow Ascent device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA clearance letter does not explicitly state pre-defined acceptance criteria in terms of specific performance metrics (like sensitivity, specificity, or % reduction). Instead, the clinical study's primary efficacy endpoint served as the performance criterion for effectiveness.

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

• Sample Size (Clinical Study): 23 participants were enrolled, and 20 received tAN therapy.
• Data Provenance: The study was conducted at two US sites, making the data provenance United States and prospective (as it was a designed clinical study for this purpose).

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

The document does not mention the use of experts to establish a "ground truth" for the test set in the traditional sense of image interpretation or diagnosis. The ground truth for effectiveness was based on the Clinical Opiate Withdrawal Scale (COWS) scores, which are a standardized and objective measure of opioid withdrawal symptoms. These scores are typically assessed by trained clinical personnel. The document does not specify the number or qualifications of the personnel who administered the COWS scores in this study.

4. Adjudication Method for the Test Set

The document does not describe a traditional adjudication method for the test set data (e.g., 2+1, 3+1). The primary and secondary endpoints were based on changes in COWS scores, which are quantitative measures. The study was a double-blind, randomized, controlled study, which inherently helps to reduce bias in the assessment of outcomes.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The device is a direct treatment device (nerve stimulator), not an AI-powered diagnostic tool for interpretation by human readers. Therefore, the concept of "how much human readers improve with AI vs without AI assistance" is not applicable here.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

The device itself is a "standalone" therapeutic device (a transcutaneous nerve stimulator) that delivers stimulation. It does not involve an algorithm providing outputs for human interpretation. Its performance is assessed directly on patient outcomes (reduction in COWS scores). The "algorithm" in this context refers to the device's operational parameters, not an AI diagnostic algorithm. The study described assesses the device's direct therapeutic effectiveness.

7. The Type of Ground Truth Used

The ground truth for the effectiveness study was clinical symptom scores (COWS scores), which are a standardized and objective measure of opioid withdrawal severity. Safety ground truth was based on reported adverse events (AEs).

8. The Sample Size for the Training Set

The document refers to the clinical study of the predicate device (K201873) and "leverag[ing] prior clinical testing" for effectiveness, but it primarily details the study performed for the current device (Sparrow Ascent). It's not clear if there was a separate "training set" in the context of machine learning, as this is a medical device, not an AI algorithm. The study described appears to be the primary clinical evidence for the device's effectiveness.

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

As this is a medical device and not an AI algorithm, the concept of a "training set" and establishing "ground truth for the training set" in the machine learning sense is not directly applicable. The effectiveness was established through a prospective, double-blind, randomized, controlled multi-center clinical study evaluating the impact of the nerve stimulator on COWS scores, as described in section 7 above. The summary also references the prior clearance of the predicate device (NSS-2 Bridge, DEN170018) which would have undergone its own clinical studies to establish similar effectiveness.

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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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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:

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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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

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.

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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

• 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

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