(87 days)
The StimPad OTC is indicated for the relief of pain associated with sore or aching muscles of the lower back, arms, or legs due to strain from exercise or normal household work activities.
The StimPad® OTC is a non-invasive nerve stimulation therapy device that can be placed directly at the site of pain for direct electrical stimulation. Stimulation is achieved through self-contained electrodes that are snap fit connected to the electronic components. There are no separate wires or electrode pads. The StimPad® OTC is powered by a replaceable, 3 volt Lithium battery (CR2032). The StimPad™ device has pre-programmed settings for frequency (ie, 7.1 Hz), pulse width (ie, 47 milliseconds for the low, medium and high intensity settings at 500 ohms, 2000 ohms, and 10,000 ohms) and the timed setting for treatment duration (4 seconds or less). The treatment duration is limited to four seconds or less of stimulation per application/treatment, and the user is prevented from modifying this setting. The intensity levels can be adjusted between low (stimulation is usually imperceptible), medium (usually the most comfortable), and high (maximum level for comfort).
I am sorry, but the provided text does not contain the specific information required to answer your request regarding the acceptance criteria and the study that proves the device meets them. The document is a 510(k) summary for the StimPad OTC device, which primarily focuses on demonstrating substantial equivalence to predicate devices for regulatory purposes.
Here's a breakdown of what's missing:
- Acceptance Criteria Table: There is no explicit table of acceptance criteria for performance metrics (e.g., sensitivity, specificity, accuracy, etc.) for the device itself. The document focuses on comparing electrical and physical parameters to predicate devices.
- Reported Device Performance: While there are output specifications and compliance with safety standards, there are no reported performance metrics against specific clinical or technical acceptance criteria.
- Study Details for Performance: The document mentions a "formal usability evaluation study" to confirm appropriateness for OTC use. However, it does not provide details like:
- Sample size used for the test set.
- Data provenance (country of origin, retrospective/prospective).
- Number and qualifications of experts.
- Adjudication method.
- Whether it was a MRMC study or a standalone study.
- Type of ground truth used.
- Sample size for the training set (if applicable for a usability study).
- How ground truth for the training set was established.
The document mainly discusses the technical characteristics and safety compliance of the StimPad OTC in comparison to its predicate devices to establish substantial equivalence. It highlights that the "StimPad® OTC and StimPad® have different indications for use and intended user populations since the former is an over the counter use device and the latter is a prescription use device. Empirical proof of substantial equivalence was not necessary in this instance since the difference between the devices is simply that StimPad® OTC is available for OTC use rather than prescription by medical practitioner. Adequacy of the StimPad® OTC for OTC use was determined by formal usability evaluation study. The study confirms that StimPad® OTC is appropriate for over the counter use."
Therefore, while a usability study was conducted, the detailed information about its methodology and results, as requested in your prompt, is not present in this document.
§ 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).