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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.

Note: The document distinguishes between "Group A" and "Group B" as "First Treatment Arm" and "Second Treatment Arm," respectively. However, in the section "However, treatment B (First Relief device) was the more effective one at reducing the ONLS and HAM scores over the long term," it clarifies that "treatment B" refers to the First Relief device, while also stating earlier that "Patients in two out of the three arms received the First Relief (Group A - first treatment arm)". This creates a slight ambiguity in direct mapping, but the key takeaway is that the First Relief device was associated with significant improvements in Group B.

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

• Sample Size (Clinical Study): 63 patients
• Data Provenance: Single center, prospective study. The document does not specify the country of origin, but given the FDA submission, it is likely a US-based study or a study accepted by the FDA.
• Test Set Description: Patients (30-74 years old; mean age = 57.0 ± 9.1 years) with Type II diabetes and diabetic peripheral neuropathy. Included patients were 18-75 years of age, with known diabetes mellitus for a minimum of 5 years, and diabetic neuropathic pain based on Toronto Expert Panel criteria.

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

This information is not provided in the document. The clinical trial relied on patient-reported outcomes (e.g., VAS, ISI, HAM-A) and objective measurements (VPT, ONLS) that are standard in clinical research, rather than expert-established ground truth in the context of interpretation of medical images or diagnostic tests. Diabetic peripheral neuropathy diagnosis was made after "a careful clinical examination."

4. Adjudication method for the test set:

This information is not provided as it is not a study focused on a "test set" in the context of independent evaluation of output from an algorithm needing adjudication. The clinical trial was double-blinded, implying that neither the patients nor the clinicians assessing outcomes knew if the patient was receiving the active device, the sham device, or the comparison device. This is a form of blinding to reduce bias, but not "adjudication" in the sense of resolving discrepancies in expert interpretations.

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 type of study is typically performed for AI/CADe systems that assist human readers in tasks like image interpretation. The "First Relief" is a therapeutic electrical nerve stimulator, not an AI software intended to assist human readers.

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

The device is a physical medical device with a specific therapeutic function, not an AI algorithm. Therefore, the concept of "standalone algorithm performance" is not applicable. The device operates independently once applied, delivering electrical stimulation.

7. The type of ground truth used:

• The "ground truth" in this clinical study (rather than an imaging or diagnostic study context) was based on patient-reported outcomes and objective clinical assessments of pain, nerve function, sleep, and anxiety.
  • Pain Intensity: Visual Analog Scale (VAS) score (patient-reported).
  • Nerve Function: Vibration Perception Threshold (VPT) value (objective measurement).
  • Insomnia: Insomnia Severity Index (ISI) (patient-reported).
  • Neuropathy Limitations: Overall Neuropathy Limitations Scale (ONLS) (likely clinician-assessed based on functional limitations).
  • Anxiety: Hamilton Rating Scale for Anxiety - A (HAM-A) (clinician-assessed based on interview).
  • Diabetic peripheral neuropathy diagnosis: "made after a careful clinical examination" based on Toronto Expert Panel criteria.

8. The sample size for the training set:

This information is not applicable and not provided. The "First Relief" is a physical medical device, not an AI/ML algorithm that requires a "training set." The clinical study described served as validation for its safety and effectiveness.

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

This information is not applicable and not provided for the reasons stated in point 8.

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