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The Primary Relief is a percutaneous electrical nerve stimulator (PENS) system indicated for up to 3 days for symptomatic relief of post-operative pain following cesarean section delivery or up to 3 days adjunctive symptomatic relief of post-operative pain following cardiac surgery.

The Primary Relief is designed to aid in the reduction of post-operative pain by the method of cranial electrical stimulation at the auricular stimulation points. The Primary Relief is a wearable, battery-operated device that is designed to administer periodical low level electrical pulses to the ear over three days / 72 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 72 hours. There stimulation 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 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.

Here's a breakdown of the acceptance criteria and study information for the Primary Relief device, based on the provided FDA 510(k) summary:

Description of Acceptance Criteria and Proving Study

The acceptance criteria for the Primary Relief device appear to be primarily focused on demonstrating its effectiveness in reducing post-operative pain, specifically after cardiac surgery, to support its expanded indications for use. The study aimed to show a statistically significant reduction in pain scores compared to a sham device.

1. Table of Acceptance Criteria and Reported Device Performance

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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 Primary Relief is a percutaneous electrical nerve stimulator (PENS) system indicated for up to 3 days for symptomatic relief of post-operative pain following cesarean section delivery.

The Primary Relief is a wearable, battery-operated device that is designed to administer periodical low level electrical pulses to the ear over 3 days / 72 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 72 hours. There are three stimulation 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. 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.

Here's a breakdown of the acceptance criteria and study details for the DyAnsys Primary Relief device, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document doesn't explicitly list "acceptance criteria" in the traditional sense of specific quantitative thresholds the device needed to meet. Instead, it focuses on demonstrating substantial equivalence to a predicate device (SPRINT PNS System) and safety/effectiveness through clinical and non-clinical testing.

Here’s a table summarizing the performance aspects evaluated and the reported results:

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The First Relief is a percutaneous electrical nerve stimulator (PENS) system indicated for multiple treatments up to 56 days for symptomatic relief of chronic, intractable pain from diabetic peripheral neuropathy.

The First Relief is designed to aid in the treatment of chronic pain symptoms by the method of cranial electrical stimulation at the auricular stimulation points. The First Relief is a wearable, battery-operated device that is designed to administer periodical low level electrical pulses to the ear over seven days / 168 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 168 hours. There stimulation 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.

Here's an analysis of the provided text to extract the requested information about the device's acceptance criteria and the study proving it:

The provided 510(k) Summary for the "First Relief" device (K212859) describes a clinical study to support its substantial equivalence to a predicate device. However, it does not present specific quantitative acceptance criteria or reported device performance in a direct comparison table as requested. Instead, it discusses the outcomes of the clinical study, focusing on statistical significance of pain and other related scores, and states that these "demonstrated the safety of the therapy" and "showed similar improvements."

There is no mention of a "test set" and its specific characteristics (sample size, data provenance), "ground truth" establishment, "adjudication method," or "MRMC comparative effectiveness study" in the context of specific quantitative metrics for acceptance. The study is a comparative clinical trial, not an AI or imaging-based device study that would typically involve those details.

Based on the provided text, I will present the information that is available and clearly state what is not available as per your request.

1. Table of acceptance criteria and the reported device performance:

As mentioned, the document does not explicitly state quantitative acceptance criteria (e.g., "VAS score reduction of X points is acceptable") or a direct comparison table of these criteria against reported device performance, which is common for algorithm-based devices. Instead, it describes the results of a clinical trial designed to show improvement. Therefore, the "reported device performance" below reflects the observed clinical outcomes rather than directly matching pre-defined acceptance criteria.

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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 First Relief v1 is a percutaneous electrical nerve field stimulator (PENFS) system intended to be used in patients 11-18 years of age with functional abdominal pain associated with irritable bowel syndrome (IBS). The First Relief v1 is intended to be used for 120 hours per week up to 3 consecutive weeks, through application to Cranial Nerves V, VII, IX and X, and the occipital nerves identified by trans-illumination, as an aid in the reduction of pain when with other therapies for IBS.

The First Relief v1 is designed to aid in the reduction of pain when combined with other therapies of IBS in patients 11 - 18 years of age with Functional Pain associated with the Irritable bowel syndrome (IBS) by the method of Cranial electrical stimulation at the auricular stimulation points. The First 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 (V, VII, IX and X) 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.

This FDA 510(k) summary for the "First Relief v1" device does not contain a study that establishes acceptance criteria and then proves the device meets those criteria. Instead, it focuses on demonstrating substantial equivalence to a predicate device ("IB-Stim", DEN180057) through non-clinical testing and comparison of technical characteristics.

Here's a breakdown of the information that is and is not available in the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not present a formal table of acceptance criteria derived from a clinical trial or performance study, nor does it report specific device performance metrics against such criteria. The comparison table provided (pages 4-5) details the technical characteristics of the applicant's device (First Relief v1), their own previous device (Drug Relief), and the predicate device (IB-Stim). It highlights similarities and minor differences in design and specifications, not performance outcomes against predefined acceptance criteria.

2. Sample size used for the test set and data provenance:

• Sample size: Not applicable, as no clinical test set for performance against acceptance criteria is described. The document mentions "non-clinical testing" and "bench tests" but does not specify sample sizes for these.
• Data provenance: Not applicable for a clinical test set. The data presented are technical specifications and test results from non-clinical (bench) testing.

3. Number of experts used to establish the ground truth for the test set and their qualifications:

Not applicable, as no clinical test set with human-established ground truth is described.

4. Adjudication method for the test set:

Not applicable, as no clinical test set requiring adjudication is described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size:

No MRMC comparative effectiveness study is mentioned. The document focuses on demonstrating physical and technical equivalence to a predicate device.

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

Not applicable. The "First Relief v1" is a physical medical device (percutaneous electrical nerve field stimulator), not an algorithm or software requiring standalone performance evaluation in the context of AI.

7. The type of ground truth used:

Not applicable, as there is no clinical study that would require a ground truth determination for diagnostic or treatment outcomes. The "ground truth" in this context refers to engineering specifications and performance benchmarks established during non-clinical testing (e.g., electrical output measurements).

8. The sample size for the training set:

Not applicable. This device is not an AI/ML algorithm that requires a training set.

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

Not applicable.

Summary of what is presented in the document instead:

The document demonstrates substantial equivalence to the predicate device (IB-Stim) based on:

• Intended Use: Nearly identical.
• Technological Characteristics: Very similar, with minor differences outlined in the table (e.g., product dimensions, weight, battery type/capacity, wire assembly type, sterilization method, shelf life).
• Non-Clinical Performance Testing: "The First Relief v1 has equivalent Performance specifications when compared to the predicate device." This includes functional testing for 120 hours to monitor continuous performance, capturing pulse width, pulse duration, amplitude, and current values.
• Compliance with Standards: The device complies with a list of IEC and ISO standards related to electrical safety, EMC, biocompatibility, and sterilization.
• Sterilization Testing: Detailed information on EtO sterilization validation for the needle package.
• Biocompatibility Testing: Performed per ISO 10993.

The key statement regarding performance is: "The First Relief v1 has equivalent Performance specifications when compared to the predicate device." This is a qualitative statement based on non-clinical (bench) testing, rather than a quantitative comparison against specific acceptance criteria from a clinical study. The FDA's clearance is based on the argument that these similarities and non-clinical test results demonstrate that the new device is as safe and effective as the predicate.

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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 ANSiStim-PP is an electro-acupuncture device for use in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states.

The ANSiStim®-PP is a wearable, battery-operated device that is designed to administer continuous low-level electrical pulses to the ear over four days / 96 hours from the time of activation of the device. The electrical pulse from the device will be delivered to the stimulation point 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 96 hours. There are three Stimulation needles 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 auricular cranial nerves. The ground electrode is inserted at one specific point (constant in all treatments) which forms the functional earthing to the device is also provided with a bottom ground.

There are three options available for using the ground terminal in the device. Either the ground electrode or the bottom ground can be used. Or both the ground electrode and bottom ground can be used together.

This constant current source guarantees equivalent stimulation energy regardless of the individual impedance of the skin. The treatment period varies based on the severity of the pain in the individual.

The stimulation pattern consists of 1 Hz single pulses with square waveform. The current direction is inverted every second pulse, which is intended to avoid polarization effects. To minimize the risk of adaption or tolerance to the electrical stimulation is applied for 3 hours, followed by a pause of 3 hours.

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.

This document, a 510(k) summary for the ANSiStim-PP device (K170391), describes the device and its comparison to a predicate device (ANSiStim, K141168). However, it does not contain the level of detail typically found in a clinical study report that would address many of the specific questions about acceptance criteria and study design for a device's performance.

The focus of this 510(k) is demonstrating substantial equivalence to a legally marketed predicate device through performance testing, indicating that the new device meets the same safety and effectiveness standards without requiring a new clinical study. It is not a clinical study proving performance against specific clinical acceptance criteria for an AI or diagnostic device in the way your prompt describes.

Therefore, I cannot provide a direct answer to most of your questions as the information is not present in the provided text. The document refers primarily to bench testing, compliance with standards, and non-clinical testing to demonstrate equivalence.

Here's what I can extract and address based on the provided text, and where the information is not available:

Acceptance Criteria and Study Details (Based on the provided K170391 510(k) Summary):

1. Table of Acceptance Criteria and Reported Device Performance

• Acceptance Criteria: The document implies that the acceptance criteria for the ANSiStim-PP device are that its "Performance specifications" are equivalent to the predicate device (ANSiStim K141168). This is assessed through "Performance testing" and "functional test" for 96 hours.

• Reported Device Performance:
  "The ANSiStim®-PP has equivalent Performance specifications when compared to the predicate device."
  "The functional test is performed for 96 hours to monitor the 3 hours ON state followed by 3 hours OFF state. The pulse duration, amplitude and current values are captured for the ANSiStim®-PP device."
  "The bench test has been performed and found that the ANSiStim®PP met all the requirements specifications and standards requirements."

  Specific performance values (e.g., exact pulse duration, amplitude, current ranges) are not detailed in this summary for the ANCIStim-PP, nor are the specific numerical targets for "equivalence" to the predicate. It states they are "equivalent" and "met all requirements."

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

• Not Applicable / Not Provided. This document describes non-clinical bench testing, not a clinical test set with patient data. The "test set" would be the manufactured devices themselves that undergo performance testing. There is no information on the number of units tested.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not Applicable. This is not a study that uses expert review for ground truth establishment. The performance testing is against engineering specifications and compliance standards.

4. Adjudication method for the test set

• Not Applicable. No human adjudication of results is described as this is not a diagnostic device with subjective outputs requiring expert consensus.

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 is an electro-acupuncture device, not an AI-assisted diagnostic imaging device. No MRMC study was performed or is relevant here.

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

• Not Applicable. This is a hardware device that delivers electrical pulses. Its performance is measured by its output characteristics (current, frequency, waveform, duration). It does not have an "algorithm-only" mode in the context of AI.

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

• The "ground truth" for this device's performance testing would be the engineering specifications and established standards (e.g., IEC 60601-1, ISO 10993 series) for electrical characteristics, biocompatibility, and sterilization, as well as the performance values of the legally marketed predicate device.

8. The sample size for the training set

• Not Applicable. This is not an AI/ML device that requires a training set.

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

• Not Applicable. As above, no training set for an AI/ML model.

In summary, this 510(k) notification focuses on demonstrating substantial equivalence through engineering and laboratory testing (bench testing, functional testing for 96 hours, biocompatibility, sterilization, electrical safety, EMC) against a predicate device and relevant international standards. It does not involve a clinical study with patient data, expert review, or AI performance metrics as typically required for more complex diagnostic or AI-driven medical devices.

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The ANSiStim™ is an electro-acupuncture device for use in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states.

The ANSiStim™ is a wearable battery-operated device that is designed to administer continuous low-level electrical pulses at the ear over four days. The stimulation needles are inserted at three specific points, which have the ability to stimulate the acupoints in the human body. Three zinc air batteries with 1.4 V provide the required stimulation energy for a maximum of 96 hours. This constant current source guarantees equivalent stimulation energy regardless of the individual impedance of the skin. The stimulation pattern consists of 1 Hz single pulses with square waveform. The current direction is inverted every second pulse, which is intended to avoid polarization effects. To minimize the risk of adaption or tolerance to the electrical stimulation, stimulation is applied for 3 hours, followed by a pause of 3 hours.

Here's a breakdown of the acceptance criteria and study information for the ANSiStim™ device based on the provided text:

Acceptance Criteria and Device Performance

The ANSiStim™ device demonstrates substantial equivalence to its predicate device (P-STIM, K050123) through performance, biocompatibility, and sterilization testing.

Table 1: Acceptance Criteria and Reported Device Performance

• Acute Systemic Toxicity study (ISO 10993-11:2006)
• Subcutaneous Implantation (1-week) study (ISO 10993-6:2007)
• Skin Sensitization Study (ISO 10993-10:2010)
• Intracutaneous Reactivity Test (ISO 10993-10:2010)
• Test for in vitro cytotoxicity (ISO 10993-5:2009)
• Biocompatibility testing for 3M materials (Foam Pad, Adhesive Tape, Conductive Adhesive) per ISO 10993-1 standards (e.g., In Vitro Cytotoxicity, Skin Irritation, Sensitization). | Acute Systemic Toxicity study in Swiss albino mice: No mortality, morbidity, clinical signs, or gross/clinical/histopathology changes; all animals showed increased body weight. Conclusion: "No systemic toxicity."
  Subcutaneous Implantation (1-week) study in Wistar rats: No mortality, morbidity, or clinical signs; all animals showed increased body weight. Average difference in biological response between test and control sites was 0.4. Conclusion: "Non-irritant."
  Skin Sensitization Study in Guinea pigs: No mortality, morbidity, or sensitization reactions; all animals showed increased body weight. Conclusion: "No sensitization reactions."
  Intracutaneous Reactivity Test in New Zealand White rabbits: No mortality, morbidity, or clinical signs; all animals showed increased body weight. No intracutaneous reactivity. Conclusion: "No intracutaneous reactivity."
  Test for in vitro cytotoxicity (Elution method): Cultures treated with test item extracts in different dilutions graded as 0. Conclusion: "Non-cytotoxic."
  3M Material Testing: Foam Pad, Adhesive Tape, and Conductive Adhesive demonstrated compliance with ISO 10993-1 for relevant tests (Cytotoxicity, Skin Irritation, Sensitization).
  Overall Conclusion: "ANSiStim™ did not show any signs of toxicity, non-cytotoxic, no induced sensitization, non-irritant and intracutaneous reactivity within limits throughout the experimental period." |
  | Sterilization Testing | Needle package subjected to bio-burden test.
  EtO Sterilization using bio-burden approach to achieve defined sterility assurance level (SAL).
  Biological indicators (BIs) used to ensure sterility.
  Chemical indicator on needle packs.
  Sterility test shows no turbidity.
  Residual risk report in line with standards.
  Evaluated and confirmed shelf-life.
  Transportation and Distribution study conducted.
  Compliance with ISO 11135:2014, ISO 11140-1:2005/(R)2010, ISO 10993-7:2008/(R)2012, ISO 11737-1:2006/(R)2011, ISO 11737-2:2009, ISO 11138-2:2006/(R)2010. | Bio-burden test: Performed on needle package.
  EtO Sterilization: Used for needle assembly with defined parameters.
  Sterility Assurance: Ensured by appropriate biological indicators.
  Chemical Indicator: Present on needle packages.
  Sterility Test: Indicated no turbidity.
  Residual Risk Report: Evidenced results inline with standards.
  Shelf-life: Evaluated and confirmed.
  Transportation and Distribution Study: Conducted.
  Overall Conclusion: Sterilization process and results meet specified ISO standards. |
  | Device Specifications (Comparison to Predicate) | Indication of Use, dimensions, weight, needle dimensions, frequency, current, waveform, battery operation, battery type, number/voltage of batteries, operating time. Temperatures and Humidity may show "improved specification validated by test report" compared to predicate. | Indication of Use: Identical to predicate.
  Dimensions: Identical (63288 mm).
  Weight: Identical (5 gm including battery).
  Needle Dimensions: Identical (0.42 mm).
  Frequency: Identical (1Hz).
  Current: Identical (~1mA).
  Waveform: Identical (Square Pulse).
  Battery Operation: Identical (Yes).
  Battery Type: Identical (Zinc Air, AC A10).
  No./Voltage: Identical (31.4V).
  Operating Time: Identical (96 h).
  Operating Temperature: 5°C to 45°C (Predicate: 5°C to 30°C) - "Improved specification validated by test report."
  Operating Humidity (Non-Condensing): 40% to 80% (Predicate: 40% to 60%) - "Improved specification validated by test report." |

Study Details

The provided document describes a summative report for a 510(k) premarket notification, which focuses on demonstrating substantial equivalence to a previously cleared predicate device (P-STIM, K050123). This is primarily achieved through bench testing for performance, biocompatibility, and sterilization, rather than clinical trials involving human participants or elaborate AI model evaluation.

Regarding the specific questions:

1. A table of acceptance criteria and the reported device performance: See Table 1 above.

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

   • Test Set Sample Size:
     • Performance Testing: Not explicitly stated but refers to "each unit" for functional tests and "the ANSiStim™ and its predicate device" for comparative analysis. This implies multiple units or components were tested.
     • Biocompatibility Testing:
       • Acute Systemic Toxicity: Swiss albino mice (number not specified).
       • Subcutaneous Implantation: Wistar rats (number not specified).
       • Skin Sensitization: Guinea pigs (number not specified).
       • Intracutaneous Reactivity: New Zealand White rabbits (number not specified).
       • In vitro cytotoxicity: Cell cultures (number not specified).
       • 3M Material Testing: Performed by 3M, details not specified but likely involves standard biological testing methodologies.
     • Sterilization Testing: "Each batch of needle assembly" is subjected to tests. Specific number of samples per batch not provided.
   • Data Provenance: The document states DyAnsys, Inc. is located in San Mateo, CA, USA, and refers to "DyAnsys India Pvt Ltd" in the biocompatibility conclusion. This suggests testing may have occurred in multiple locations or been managed by the Indian subsidiary. The testing is prospective in the sense that the device was specifically tested to demonstrate equivalence for this submission.

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):

   • Not applicable in the context of this 510(k) submission. The "ground truth" here is compliance with established engineering, electrical, and international biocompatibility/sterilization standards, as well as demonstrating comparable function to a legally marketed predicate device. This is evaluated by technical experts in those fields (e.g., toxicologists, microbiologists, electrical engineers) typically working for testing labs, consistent with the reference to "the test lab concluded." The document does not describe a clinical study requiring expert consensus on diagnoses or outcomes.

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

   • None. This type of adjudication is typically relevant for clinical studies or image-based diagnostic AI, where multiple human readers assess cases and discrepancies need resolution. This 510(k) predominantly relies on objective measurements from bench testing and adherence to published standards.

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, an MRMC comparative effectiveness study was not done. This device is an electro-acupuncture stimulator, not an AI-powered diagnostic or assistive tool for human readers. Its substantial equivalence is based on its physical properties, electrical performance, and safety (biocompatibility, sterilization), not on improving human interpretation of medical data.

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

   • No. This device is a hardware electro-acupuncture stimulator, not an algorithm. Its "standalone performance" is demonstrated through its functional tests and comparison of its electrical output to the predicate device.

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

   • The "ground truth" for this submission is primarily objective measurements against engineering specifications and international standards, along with demonstrated equivalence to the performance and safety profiles of the predicate device.
     • Performance: Measured electrical parameters (pulse width, duration, amplitude, current) against design specifications and comparison to predicate.
     • Biocompatibility: Biological responses (toxicity, irritation, sensitization, cytotoxicity) measured against acceptance criteria defined by ISO 10993 standards.
     • Sterilization: Microbiological tests (bio-burden, sterility), and chemical indicator checks against ISO 11135 and related standards.

8. The sample size for the training set:

   • Not applicable. This device is a physical stimulator, not an AI/machine learning algorithm requiring a "training set" in the conventional sense.

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

   • Not applicable. As a non-AI physical medical device, there is no "training set" or corresponding ground truth establishment process in the context of machine learning. The device's design and manufacturing are based on established engineering principles and prior validated devices.

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