(190 days)
The WiTouch" Pro Transcutaneous Electrical Nerve Stimulator Device is used for the symptomatic relief and management of chronic intractable back pain and relief of pain of the upper and lower back associated with arthritis. It is also used for adjunctive treatment for post-surgical and post-trauma acute back pain.
The WiTouch™ Pro medical device is a Transcutaneous Electrical Nerve Stimulator (TENS) used to reduce the perception of pain by electrically stimulating peripheral nerves across the skin (transcutaneously). The design consists of a battery powered current generator with integral electrodes and replaceable electrical dispersive hydrogel pads (gel-pads). One side of the adhesive gel-pad adhere to the integral electrode, and the other side adhere the device to the healthy intact skin of the patient's back to provide a transcutaneous analgesic electrical stimulus to the painful area.
The provided 510(k) summary for the WiTouch™ Pro Transcutaneous Electrical Nerve Stimulator (TENS) device does not contain information about acceptance criteria or a dedicated study to prove that the device meets specific performance criteria in the way a diagnostic AI/ML device would.
This 510(k) submission focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and safety standards, rather than performance metrics related to diagnostic accuracy or clinical outcomes of a new treatment modality.
Here's a breakdown of why many of your requested items cannot be fulfilled from this document:
- Acceptance Criteria & Reported Performance: This document doesn't define quantitative performance acceptance criteria (e.g., sensitivity, specificity, accuracy, F1-score) for the device's efficacy in pain relief. Instead, it compares technical specifications (waveform, current density, power density, physical characteristics) to predicate devices to argue substantial equivalence.
- Sample Size, Data Provenance, Expert Ground Truth, Adjudication, MRMC, Standalone Performance, Ground Truth Type for Test Set: These are all concepts relevant to studies evaluating the diagnostic or therapeutic performance of a device or algorithm, often involving patient data and human expert review. This 510(k) does not describe such a study. The "study" here is essentially the comparison of technical specifications against FDA-recognized safety and electrical standards and existing predicate devices.
- Training Set Sample Size & Ground Truth: These are concepts for AI/ML model development. The WiTouch™ Pro is a hardware TENS device, not an AI/ML diagnostic tool, so these concepts do not apply in this context.
Summary of Information Available from the Document:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state "acceptance criteria" in terms of performance metrics like sensitivity or specificity. Instead, it demonstrates inherent safety and equivalence through compliance with recognized standards and comparison of technical specifications to legally marketed predicate devices. The "reported device performance" is essentially that its electrical output and physical characteristics are within acceptable ranges and comparable to existing TENS devices.
| Acceptance Criteria (Implied by Predicate Comparison & Standards) | Reported Device Performance (WiTouch™ Pro) |
|---|---|
| Maximum average power density of electrodes with gel-pads |
§ 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).