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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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