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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:

2. Sample Size for Test Set and Data Provenance

• Sample Size for Test Set: 44 participants.
  • Intervention group: 22 participants (mean age = 24.7 ± 2.6 years)
  • Control group: 22 participants (mean age = 26.6 ± 3.9 years)
• Data Provenance: Single center, prospective study. The country of origin is not explicitly stated in the provided text, but the company address is San Mateo, CA, USA, suggesting the study likely took place in the US or was conducted under US regulatory standards.

3. Number of Experts and Qualifications for Ground Truth

• The ground truth in this study is based on patient-reported outcomes using the Numerical Rating Scale (NRS) for pain intensity and quality of life measures.
• No external experts were explicitly stated to establish ground truth for individual cases in the test set. The patients themselves provided the primary data. Medical professionals would have been involved in the administration of the study, data collection, and assessment of participants, but not in establishing an "expert ground truth" as might be seen in imaging studies.

4. Adjudication Method

• None as described. The primary and secondary endpoints were measured directly from patient self-reports using the Numerical Rating Scale (NRS). This method does not typically involve an adjudication process among experts for interpretation.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No. This was a clinical trial comparing a device to a control group for pain relief, not an MRMC study comparing human reader performance with and without AI assistance for interpretation tasks. The device itself is a therapeutic stimulus, not an AI diagnostic aid.

6. Standalone (Algorithm Only) Performance

• Yes, in the sense of the device operating independently. The Primary Relief device is a therapeutic device that delivers electrical stimulation. Its "performance" refers to its ability to generate specific electrical pulses and the clinical outcome from those pulses.
• The "standalone performance" was evaluated through:
  • Performance bench testing: Validating effectiveness of each unit, comparing effectual output with a reference device, and monitoring continuous performance for 72 hours.
  • Clinical study: The device was administered to the intervention group without human-in-the-loop interpretation or modification of its core function during the treatment period. The human "in the loop" was the prescriber and the patient. While a healthcare professional inserts the needles, the device then operates autonomously to deliver stimulation.

7. Type of Ground Truth Used

• Patient-reported outcomes: Specifically, the Numerical Rating Scale (NRS) for:
  • Pain intensity (primary efficacy endpoint)
  • Six measures intended to assess quality of life (secondary efficacy endpoints)

8. Sample Size for the Training Set

• Not applicable / Not explicitly mentioned. The provided document describes a clinical study to evaluate the device, not a machine learning model that would have a "training set." The Primary Relief device is a hardware therapeutic device, not an AI algorithm that learns from data.

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

• Not applicable. As there is no machine learning component described, there is no "training set" or "ground truth for the training set" in the context of AI development.

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