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TENS:
To be used for the temporary relief of pain associated with sore or aching muscles in the shoulder, waist, back, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities.

EMS:
It is intended for muscle conditioning, used for stimulating abdomen muscles in order to improve or facilitate muscle performance.

The Hi-Dow Wireless TENS/EMS System is a battery operated wireless pulse generator that uses radiofrequency signals sent from a wireless remote control unit to wireless receivers attached to the electrodes(s), which are attached to the skin at the area to be treated. The wireless remote controls the intensity and mode functions of the receiver. When used in TENS Modes, the electrical impulses generated by the receivers stimulate the nerves that are causing pain resulting in gentle electrical sensations instead of pain. When used in EMS modes, the electrical impulses generated by the receivers produce muscle contractions, these contractions help to condition and improve the muscles.

The Hi-Dow Wireless TENS/EMS System is a double-channel and 4 modes muscle stimulation system that helps to relieve minor muscular aches and pains.

The output of both channels can be adjusted individually for intensity in 20 levels and the treatment time is 45 minutes.

The device is powered by rechargeable Lithium Batteries which are permanently built into the main unit and can be recharged with the charging unit supplied with the device.

The Device consists of an electronic stimulatory module which generates the required stimulation signals, 3 sets of electrode pads and a plug-in charging unit.

The electrodes are designed for single-patient/multiple application use. Because of the adhesive nature of the biocompatible conductive hydro gel, no securing materials are required to secure the device to the patient's skin. The electrodes snap onto the receiver.

The provided text is a 510(k) summary for the Hi-Dow Wireless TENS/EMS System, Model HD-5N. This document focuses on demonstrating substantial equivalence to previously cleared devices rather than providing detailed acceptance criteria and studies in the traditional sense of a clinical trial for novel device approval.

Therefore, the acceptance criteria and study information will be presented as they relate to the substantial equivalence determination for this type of device.

Here's the breakdown of the information requested, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

For a 510(k) submission, the "acceptance criteria" are typically demonstrating compliance with recognized standards and similarity to predicate devices, and "reported device performance" refers to the results of testing done to show this compliance and similarity.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: Not applicable in the context of this 510(k) summary. The "test set" here refers to the actual device undergoing engineering and performance testing against standards, not a clinical data set. The document does not specify the number of units tested.
• Data Provenance: The tests for biocompatibility, electrical safety, EMC, and software verification/validation are typically conducted in a laboratory setting. The country of origin of the data is not specified, but the manufacturing entity is "Hi-Dow Electron Technology(Hefei) Inc., Ltd." which suggests China. These are prospective tests conducted on the device itself. No patient data provenance is relevant for this type of submission focused on engineering performance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable. This 510(k) submission is for an electrical stimulation device (TENS/EMS) and relies on objective measurements against engineering standards and comparison to predicate devices, not on expert consensus for "ground truth" derived from clinical data (e.g., image interpretation). Experts involved would be those certifying compliance with the listed standards (e.g., electrical engineers, biocompatibility specialists), but their number and specific qualifications are not detailed in this summary.

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

• Not applicable. Adjudication methods like 2+1 or 3+1 typically refer to clinical endpoint adjudication by multiple experts, which is not part of this device's substantial equivalence pathway. The "adjudication" here is the assessment of compliance with predefined engineering standards.

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

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices often involving AI, which is not the case for this TENS/EMS device.

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

• Not applicable. This device is an electrical stimulator, not an algorithm, and its use inherently involves human interaction (application of electrodes, control of intensity and mode). "Standalone" performance as typically understood for AI algorithms is not relevant here. The device's "standalone" performance refers to its ability to meet the specified electrical and safety parameters independently.

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

• The "ground truth" for this submission are the recognized international and national standards (e.g., IEC 60601 series, ISO 10993 series, FCC Part 15) for electrical safety, EMC, biocompatibility, and software validation, as well as the technical specifications and performance characteristics of the legally marketed predicate devices. The device's performance is compared against these objective engineering and regulatory benchmarks, not clinical "ground truth" like pathology or outcomes data.

8. The sample size for the training set

• Not applicable. This device is not an AI/ML algorithm that requires a "training set" of data.

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

• Not applicable, as no training set was used.

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