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Transcutaneous Electrical Nerve Stimulation (Program 2, 3, 4, 6, 8, 9): To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities. Powered Muscle Stimulation (Program 1, 5, 7, 10, 11, 12): It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.

MHD TENS is portable and DC 3.7V battery powered device, offering both transcutaneous electrical nerve stimulator (TENS) and powered muscle stimulator (PMS) qualities in one device. MHD TENS has 12 operation programs, which can give certain electrical pulses through electrode adhesive pads to the suggested area of the body where the electrodes are placed. The electronic stimulatory module has the operating elements of Switch, LCD Display screen, Screen lock key, Intensity Modification keys, Timing key, Output sockets, and USB port for battery charging. The LCD screen can display treatment remaining time, battery power, selected program, output port, current intensity, selected intensity and lock state. The device is equipped with accessories of electrode pads, electrode cables, a screen stylus, a battery charger and a USB cable. The electrode cables are used to connect the pads to the device; the USB cable is used to connect the AC charger and the built-in lithium battery. The screen stylus is used to touch and operate the display screen. All accessories, including the USB cable, electrode pads, electrode cables, and the charger can only be replaced by the electrodes are interchangeable. The application area of electrode pads must be larger than 12cm². The electrode pads are provided by Shenzhen Mailuokang Technology Co., Ltd. with 510(k) cleared Number K152815.

This FDA 510(k) summary describes the MHD TENS device and establishes its substantial equivalence to a predicate device (K143268). The provided document does not contain information about a study proving the device meets acceptance criteria in the manner typically expected for AI/ML device performance (e.g., clinical study with human readers, ground truth establishment, etc.). This is because the MHD TENS is a physical electrical stimulation device, not an AI/ML diagnostic or therapeutic system.

Instead, the "acceptance criteria" for a device like the MHD TENS are compliance with recognized electrical safety and performance standards, and comparison with a legally marketed predicate device to demonstrate substantial equivalence. The "study" proving it meets these "acceptance criteria" consists of engineering tests and comparisons to the predicate.

Here's the information extracted and formatted, noting where AI/ML-specific criteria are not applicable:

Acceptance Criteria and Device Performance for MHD TENS

Device Name: MHD TENS
510(k) Number: K190115
Predicate Device: K143268

1. Table of Acceptance Criteria (as indicated by comparison to predicate and safety standards) and Reported Device Performance

Summary of Notes on Differences:

• Note 1 (Patient Leakage Current, Programs, Channel Operation, Regulation Type): Differences in Patient Leakage Current, number of programs, channel operation (alternating vs. synchronous), and regulation type (regulated current vs. voltage control) are considered acceptable because both devices passed AAMI/ANSI ES 60601-1 and/or IEC 60601-2-10 safety standards. The fundamental output technology and similar modes are expected to offer similar treatment effects.
• Note 2 (Max Output Voltage, Current, Pulse Width, Frequencies): Differences in these parameters are considered acceptable as calculations and measurements show compliance with AAMI/ANSI ES 60601-2-10. The physiological effectiveness is primarily dependent on delivered charge, and these differences don't raise new safety/effectiveness issues.
• Note 3 (Maximum Phase Charge): The proposed device's maximum phase charge (24.3µC @500Ω) is less than the predicate (48µC @500Ω) but falls within the range of cleared devices, including the predicate's predicate (K121719 at 16.8µC @500Ω).
• Note 4 (Max Average Current, Current Density, Power Density): While different from the predicate, the proposed device's maximum current density (< 2mA/cm²) and maximum average power density (< 0.25W/cm²) comply with IEC 60601-2-10, thus not raising new safety/effectiveness issues.
• Note 5 (Accessories): The proposed device includes a screen stylus and has a touchable display screen with a lock button, which the predicate lacks. These additions do not affect output parameters or operation.

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

Not applicable in the context of an electrical stimulation device. The "test set" for this type of device refers to the device itself undergoing engineering and safety standard testing, not a dataset of patient cases. The provenance would be the test conditions under which the device was evaluated according to recognized standards.

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

Not applicable. "Ground truth" in the AI/ML sense (e.g., expert-labeled medical images) is not relevant for an electrical stimulation device's regulatory review based on substantial equivalence to a predicate. The "ground truth" for this device's performance relates to its compliance with electrical safety and performance standards (e.g., measured current, voltage, waveform characteristics). These measurements are typically performed by qualified test engineers in accredited labs.

4. Adjudication method for the test set

Not applicable. This concept (e.g., 2+1, 3+1 for clinical consensus) is for interpreting disagreements among expert readers of medical data, which is not relevant here.

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. The MHD TENS is an electrical stimulation device, not an AI-assisted diagnostic or therapeutic system involving human readers interpreting cases.

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

Not applicable. The device is a standalone hardware device. The concept of "algorithm only" or "human-in-the-loop performance" does not apply.

7. The type of ground truth used

The "ground truth" for the MHD TENS device is based on technical specifications and measurements demonstrating compliance with recognized electrical safety and performance standards (e.g., ANSI AAMI ES60601-1, IEC 60601-2-10, IEC 60601-1-2, IEC 62133, IEC 60601-1-11). It also relies on the established safety and effectiveness profile of a legally marketed predicate device (K143268) through a comparison of physical and functional characteristics.

8. The sample size for the training set

Not applicable. This device does not use a training set as it is not an AI/ML device.

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

Not applicable. This device does not use a training set.

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