(181 days)
The device is for temporary relief of pain associated with sore and aching muscles in the lower back due to strain from exercise or normal household and work activities.
The intended use is to provide approximately thirty minutes of analgesic electrical stimulus to reduce the perception of pain by electrically stimulating peripheral nerves across healthy intact skin of the user's lower back.
The device is a battery powered over the counter transcutaneous electrical nerve stimulator with a wireless remote control feature. The general purpose of the device is to apply an electrical stimulus to integral electrodes that are applied to a user's lower back to relieve pain. The device includes a current generator and permanently-affixed electrodes with user replaceable single patient use hydrogel pads (gel-pads) that may be reused for a limited number of reuses. The number of reuses of the gel-pads varv person-to-person dependent upon skin type, oils and pH levels. One side of the adhesive gel-pad adheres to the electrode, and the other the device to the healthy intact skin of the user's lower back to provide an analgesic electrical stimulus to the painful area. The user controls are located on a hand-held wireless remote control commonly referred to as a Key-fob. The user controls are simple straightforward power on/off and electrical stimulus intensity up/down.
This document describes a 510(k) premarket notification for "The Pain Pilot™ (a.k.a. Pain Pilot™) / WiTouch™," a transcutaneous electrical nerve stimulator (TENS) device. The purpose of a 510(k) submission is to demonstrate that a new device is substantially equivalent to a legally marketed predicate device, rather than to prove its efficacy through extensive clinical studies and acceptance criteria as might be seen for novel devices.
Therefore, the information provided focuses on demonstrating substantial equivalence to predicate devices based on technical characteristics and safety standards, rather than presenting a performance study with acceptance criteria in the typical sense for algorithm performance.
Here's an analysis based on the provided text, addressing your questions where possible:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" as performance metrics for an algorithm or device efficacy study. Instead, it demonstrates compliance with recognized safety standards and substantial equivalence to predicate devices based on technical specifications. The "performance" is implicitly tied to meeting these standards and being comparable to legally marketed TENS devices.
| Metric / Standard | Device Performance / Compliance |
|---|---|
| Safety Standards | |
| FDA Recognized Number 5-4, IEC 60601-1 (General) | Complies |
| FDA Recognized Number 5-60, IEC 60601-1-2 (Electromagnetic compatibility) | Complies |
| FDA Recognized Number 5-41, IEC 60601-1-4 (Programmable electrical medical systems) | Complies |
| FDA Recognized Number 17-5, IEC 60601-2-10 (Safety of nerve and muscle stimulators) | Complies |
| FDA Recognition Number 2-156, AAMI/AMSI/ ISO 10993-1 (Biological evaluation – risk management) | Complies |
| FDA Recognition Number 2-153, ISO 10993-5 (Biocompatibility – In Vitro cytotoxicity) | Complies |
| FDA Recognition Number 2-173, AAMI / ANSI / ISO 10993-10 (Biocompatibility – irritation and skin sensitization) | Complies |
| Compliance with U.S. FDA Title 21 CFR 898 Electrode Lead Wire Performance Standard | Yes |
| Technical Specifications (Comparison to Predicates) | |
| Maximum average power density of electrodes with gel-pads | Less than 0.25 watts per square centimeter (consistent with predicates to reduce thermal burn risk) |
| TENS Device Power Source | Battery 1.5VDC (2-Alkaline AAA) |
| Number of Output Modes | 4 |
| Number of Output Channels | 1 Channel, Asynchronous - Biphasic |
| Software/Firmware/Microprocessor Control? | Yes |
| Automatic Shut Off? | Yes |
| User Override Control? | Yes |
| Indicator Display (On/Off Status, Low Battery, Voltage/Current Level) | On/Off: Yes, Low Battery: Yes, Voltage/Current: No |
| Timer Range | Nonadjustable 30 minutes |
| Phase Duration | 120μs - 480μs |
| Maximum Current Density | 0.12mA @500Ω |
| Maximum Average Current | 1.6mA @500 Ω |
| Maximum Average Power Density (using 500Ω) | 0.69mW/cm² @500Ω |
2. Sample Size Used for the Test Set and Data Provenance
This document describes a 510(k) submission, which primarily relies on demonstrating substantial equivalence to existing predicate devices through technical comparisons and adherence to recognized standards. It does not present a clinical study with a "test set" and "data provenance" in the context of evaluating algorithm performance or clinical efficacy against specific acceptance criteria. The "study" here is predominantly a technical and regulatory comparison.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. As noted above, there's no clinical "test set" with ground truth established by experts for this 510(k) submission.
4. Adjudication Method for the Test Set
Not applicable. No test set requiring expert adjudication is described in the provided text.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of human readers improve with AI vs without AI assistance
Not applicable. This device is a TENS unit, not an AI-powered diagnostic or interpretive system. Therefore, no MRMC study involving human readers and AI assistance was conducted or reported.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm, so the concept of standalone algorithm performance does not apply.
7. The Type of Ground Truth Used
Not applicable. There is no "ground truth" as would be established for an AI algorithm or diagnostic test. The device's "truth" is its compliance with safety standards and its substantial equivalence to other legally marketed TENS devices.
8. The Sample Size for the Training Set
Not applicable. As this is not an AI/ML device, there is no "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable. No training set is involved.
Summary of the "Study" that Proves the Device Meets the Criteria:
The "study" presented in this 510(k) submission is a demonstration of substantial equivalence to legally marketed predicate devices, along with evidence of compliance with relevant FDA-recognized safety and performance standards.
- Methodology: The submission extensively compares the new device (The Pain Pilot™ / WiTouch™) to three predicate TENS devices (PM3030™, Painmaster™ MCT Patch, and T1040™). This comparison covers:
- Indications for Use (showing equivalence for lower back pain relief).
- Intended Use (showing equivalence in providing analgesic electrical stimulus).
- Technical specifications (e.g., power source, output modes/channels, control mechanisms, timer, dimensions, electrical characteristics like current density and power density).
- The submission argues that differences (like integral electrodes and wireless remote control) are "insignificant as it relates to safety and effectiveness, and is not critical to the intended use."
- Evidence: The primary evidence provided is the detailed table comparing the various specifications of the new device against the predicate devices (page 3 of 4). Additionally, declarations of conformity to numerous FDA-recognized international and national standards (IEC 60601 series for electrical safety, ISO 10993 for biocompatibility) are provided (page 4 of 4).
- Conclusion: The FDA's letter (pages 5-6 of 6) states that they have "determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices." This substantial equivalence determination serves as the "proof" that the device meets the regulatory "acceptance criteria" for marketing under the 510(k) pathway.
In essence, for a 510(k) submission like this for a TENS device, the acceptance criteria are satisfied by proving the new device is as safe and effective as a device already on the market through detailed technical comparison and adherence to recognized standards, rather than through a clinical trial with performance metrics.
§ 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).