(90 days)
TENS: intended for temporary relief of pain associated with sore and aching muscles in the low back as well as upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities.
EMS: intended to stimulate healthy muscles in order to improve or facilitate muscle performance. The various types of muscle work that the EMS can impose on the stimulated muscles are able to improve or facilitate muscle performance. The EMS may therefore be considered a technique of muscle training.
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The provided text is a 510(k) clearance letter from the FDA for a Transcutaneous Electrical Nerve Stimulator (TENS) and Electrical Muscle Stimulator (EMS) device (Model EM-5200). This type of device is an electrical stimulator, not an AI/ML-driven diagnostic or prognostic tool.
Therefore, the concepts of acceptance criteria, study data, ground truth, experts, and training/test sets as they relate to AI/ML device performance evaluation do not apply to this document.
The FDA clearance for TENS/EMS devices like this one is typically based on:
- Substantial Equivalence: Demonstrating that the new device is as safe and effective as a legally marketed predicate device. This often involves comparing technological characteristics (e.g., waveform, intensity, frequency, output modes) and performance data (e.g., electrical safety, electromagnetic compatibility, biocompatibility).
- Performance Testing: Benchtop testing to ensure the device meets its specifications and applicable IEC standards.
- Clinical Data (if necessary): In some cases, if the device has novel technology or a new indication, limited clinical data might be required, but it would focus on safety and effectiveness for pain relief (TENS) or muscle performance (EMS), not diagnostic accuracy or AI algorithm performance.
In summary, the information requested in your prompt (AI/ML-specific acceptance criteria, ground truth, expert review, training/test sets) is not present in this document because the device in question is a conventional electrical stimulator, not an AI/ML medical device.
§ 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).