(103 days)
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.
| Acceptance Criteria (Explicitly stated in document) | Reported Device Performance (Observed Clinical Outcomes) |
|---|---|
| Primary Efficacy Endpoint: | |
| Visual Analog Scale (VAS) score reduction | Group B (First Relief): Significant reduction that persisted for 90-day follow-up. |
| Group A (First Treatment Arm - likely a different configuration or use of First Relief): Marked improvement (3.12 reduction). | |
| Group C (Sham): 1.18 reduction (control). | |
| Secondary Efficacy Endpoints: | |
| Vibration Perception Threshold (VPT) value | Showed similar improvements to pain score. |
| Insomnia Severity Index (ISI) | Showed similar improvements to pain score, significant improvement in sleep. |
| Overall Neuropathy Limitations Scale (ONLS) | Group B: Significant difference in reduction compared to Group C (Adj. P-value = 0.007). |
| Hamilton Rating Scale for Anxiety - A (HAM-A) | Group B: Significant difference in reduction compared to Group C (Adj. P-value |
§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.
(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).