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TENS:

1. It is intended for temporary relief of pain associated with sore and aching muscles in the shoulder, neck, back, waist, abdomen, lower extremities (legs), upper extremities (arms) due to strain from exercise or normal household and work activities.
2. It is also intended for symptomatic relief and management of chronic, intractable pain associated with arthritis.
   EMS:
3. To stimulate healthy muscles to improve and facilitate muscle performance. To be used for the improvement of muscle tone and firmness, and for strengthening muscles in the intended areas on the body.
4. To be used for relaxation of muscle spasm, increase of blood flow circulation, prevention or retardation of disuse atrophy, muscle re-education, maintaining or increasing range of motion, and immediate post-surgical stimulation of calf muscles to prevent venous thrombosis.

RelieforMe TENS/EMS Device model UPK-GE01 is designed to focus on pain relief, muscle strengthening and recovery features with TENS/EMS treatment techniques driven and controlled by intelligent programs/software.
RelieforMe TENS/EMS Device, a TENS/EMS combination device, is intended for temporary relief of pain associated with sore and aching muscles in the shoulder, neck, back, waist, abdomen, lower extremities (leg), upper extremities (arm) due to strain from exercise or normal household and work activities. The device is for 18 and older.
The device provides pain relief based on the intelligent use of the key pain-killer mechanisms of TENS (Transcutaneous Electrical Nerve Stimulation).

The provided document is a 510(k) Premarket Notification for the "RelieforMe TENS/EMS Device Model UPK-GE01". It is a submission to the FDA seeking to demonstrate substantial equivalence to legally marketed predicate devices, not an AI/ML device. Therefore, the information requested about acceptance criteria, study details, expert consensus, ground truth, and training sets for an AI/ML device is not applicable or present in this document.

The document focuses on comparing the subject device's features (such as power sources, output voltage/current, frequency, pulse width, biocompatibility, electrical safety, and EMC) to those of predicate TENS/EMS devices to show that it is "as safe and effective as the predicate device" and does "not raise new questions of safety and effectiveness."

Specifically, the document states:

• Non-Clinical Performance Data: "To demonstrate safety and effectiveness of RelieforMe TENS/EMS Device model UPK-GE01 and to show substantial equivalence to the predicate device, UMHEAL completed the following non-clinical tests. Results confirm that the design inputs and performance specifications for the device are met. The UPK-GE01 passed the testing in accordance with international standards shown below, supporting its safety and effectiveness, and its substantial equivalence to the predicate device:"
  • Electrical safety testing per IEC 60601-1 – Passed
  • Electromagnetic Disturbance (EMD) testing per IEC 60601-1-2 – Passed
  • Software verification and validation per FDA Guidance – results /conclusion
  • Treatment Programs Performance Verification Testing
  • Stability Verification Testing
  • HFE Validation Testing
  • FCC Testing
  • Transportation Testing per ASTM D4169 – Demonstrates package integrity maintained
• Clinical Performance Data: "Not applicable."

Therefore, I cannot provide the requested information regarding AI/ML specific criteria from this document.

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