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TENS & EMS Device (Model: LY-ET-01, LY-ET-02, LY-ET-04):

• To be used for temporary relief of pain associated with sore and aching muscles in the upper and lower back, back of the neck, upper extremities (shoulder and arm), lower extremities (leg and feet) due to strain from exercise or normal household work activities by applying current to stimulate nerve. To be used for symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.
• To stimulate healthy muscles in order to improve and facilitate muscle performance .
• To temporarily increase local blood circulation in healthy muscles.

TENS & EMS Device is a pain management device with a combination of TENS and EMS therapy technology.
It can stimulate healthy muscles in order to improve and facilitate muscle performance, and temporary relief of pain associated with sore and aching muscles in the upper and lower back, back of the neck, upper extremities (shoulder and arm), lower extremities (leg and feet) due to strain from exercise or normal household work activities by applying current to stimulate nerve.
TENS & EMS Device (Model: LY-ET-01, LY-ET-04) has 3 modes (Model LY-ET-02 has 5 modes) and one channel, which provide electrical pulse stimulation through the electrode pads to the treatment area. The TENS & EMS Device has the operating elements of ON/OFF knob, Mode Selection button, Intensity adjustment Dial (or Intensity Increase button and Intensity decrease button) and Time Selection button which is user-friendly and easy to control.
The device is equipped with electrode pads and electrode wire is used to connect the pads to the main unit. All the accessories can only be purchased by a local distributor.

This document describes the premarket notification (510(k)) for the TENS & EMS Device (Models LY-ET-01, LY-ET-02, LY-ET-04). This filing primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing and comparison, rather than clinical efficacy studies. Therefore, many of the requested elements for acceptance criteria and study proving device meets criteria (especially those related to AI/MRMC studies, human reader improvement, and extensive clinical ground truth establishment) are not applicable in this context.

However, based on the provided text, I can extract information related to the acceptance criteria and the non-clinical studies conducted to demonstrate the device's safety and performance in the context of electrical safety and general device functionality, as required for a TENS/EMS device.

Here's a breakdown of the available information:

1. A table of acceptance criteria and the reported device performance

The document provides a table summarizing non-clinical performance testing. The "Acceptance criteria" column states the general requirements for the tests, and the "Test results" column indicates "Pass" for all listed tests. There are no specific quantitative performance metrics provided as acceptance criteria for the TENS/EMS functionality itself (e.g., specific pain reduction percentages), as this is a non-clinical submission relying on equivalence to a predicate device.

2. Sample sized used for the test set and the data provenance

• Sample Size for Non-Clinical Testing: "The test sample is the final, finished product." For each listed test (General requirements, Electromagnetic disturbances, Home Healthcare environment, Nerve and muscle stimulators), the sample size is specified as "Model: LY-ET-01, LY-ET-02, LY-ET-04." This implies a representative sample of each device model was used for testing, but specific numerical quantities (e.g., N=3 of each model) are not given.
• Data Provenance: The tests are laboratory "bench testing" conducted by the manufacturer, Jiangxi Royall Smart Technology Co., Ltd. (China). The document does not specify if these were retrospective or prospective tests, but they are typically prospective tests performed to verify compliance with standards for the specific device being submitted. All cited standards (IEC, ISO) are international.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable. The device is a TENS & EMS stimulator, and the testing documented is non-clinical (electrical safety, EMC, biocompatibility, usability, software V&V). There is no "ground truth" in the clinical sense (e.g., for disease diagnosis or treatment efficacy) established by experts for these types of tests. Compliance is against published international standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as this is related to clinical ground truth establishment or reader studies, which were not performed.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI-powered diagnostic or therapeutic device. The submission is for a TENS & EMS device, demonstrating substantial equivalence to predicate devices through non-clinical performance and safety testing.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an algorithm-only device. It's a physical medical device.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

For the non-clinical tests, the "ground truth" is compliance with the requirements and limits defined in the referenced international standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-1-10, IEC 60601-1-11, IEC 62366-1, ISO 10993 series).

8. The sample size for the training set

Not applicable. This type of device does not involve a "training set" in the context of machine learning or AI.

9. How the ground truth for the training set was established

Not applicable, as there is no training set for this device.

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