(231 days)
The TrueRelief Device is intended for use under the supervision of a Healthcare Professional.
TrueRelief is intended for temporary symptomatic relief of chronic intractable pain, and as an adjunctive treatment in the management of post-surgical and post-traumatic acute pain.
The TrueRelief device is an AC power operated device that consists of three main components and associated power cables: the pulse generator, a primary probe and a secondary probe. The signal generator applies electromagnetic energy transcutaneously through the primary and secondary probes into painful tissue, similar to Transcutaneous Electrical Nerve Stimulation (TENS) device. The TrueRelief device uses a proprietary waveform with small voltage fluctuations to achieve pain relief.
This 510(k) summary describes a TENS device, which is not an AI/ML device. Therefore, the requested information regarding AI/ML device performance and associated studies (acceptance criteria, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) is not applicable.
The document focuses on demonstrating substantial equivalence to predicate devices through technical comparisons and compliance with electrical safety and electromagnetic compatibility standards.
Here's a breakdown of the relevant information provided:
1. A table of acceptance criteria and the reported device performance:
The document lists "Performance Testing" as a comparable characteristic between the subject device (TrueRelief Device) and its predicates. It states that "The TrueRelief Device was tested and certified to comply with recognized standards for electrical safety (IEC 60601-1, IEC 60601-2-10, IEC 60601-1-6)" and "Electromagnetic Compatibility: The TrueRelief Device was tested and certified to comply with recognized standards for electromagnetic compatibility (IEC 60601-1-2)." It also mentions "Usability/Human Factors: Usability/Human Factors were evaluated, which demonstrated that the established requirements for usability were met, and the device's design is appropriate for the intended users and use environment."
The specific acceptance criteria (e.g., maximum leakage current values) are implicitly defined by the standards listed, and the "reported device performance" is that it "complies" with these standards. The comparative table of technological characteristics also lists specific electrical parameters for the device (e.g., Patient Leakage Current
§ 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).