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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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To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, arm, leg and foot, due to strain from exercise or normal household and work activities

The Low-Frequency Therapy Instrument is a product that adopts modern electronic science and technology to produce low-frequency electrical pulse and transmit that through the skin to the underlying peripheral nerves by electrodes, in order to reach the therapeutic aim.

There are three models of Low-Frequency Therapy Instrument which are KTR-201, KTR-202, KTR-203. Their technical parameters are slightly different, but they share the basically same characteristics: 1) They are small, and exquisite; 2) they have different treatment modes which can satisfy various demands, thus can be used by a wider range of people; 3) LCD display with a big screen makes the operation easy and clear, and the contents displayed on LCD can guide the treatment.

The Low-Frequency Therapy Instrument is mainly composed of the host and electrode patches and it uses AAA batteries for power supply. To start therapy, first insert batteries, then paste the electrode patches onto treatment areas and press power button to turn the power on. The modes and intensity can be selected according to needs. The current status is displayed on LCD.

This FDA 510(k) submission describes the "Low-Frequency Therapy Instrument" (Models: KTR-201, KTR-202, KTR-203), a Transcutaneous Electrical Nerve Stimulator (TENS) for pain relief.

Here's an analysis of the acceptance criteria and supporting studies based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics. Instead, the acceptance is implied by demonstrating substantial equivalence to a predicate device (Shenzhen OSTO Technology Company Limited's Health Expert Electronic Stimulator, Model AST-300C and AST-300D, K133929) and compliance with relevant voluntary standards.

The "Technological characteristics and substantial equivalence" table (pages 5-6) serves as the core comparison for "performance." Key metrics and their comparison to the predicate are:

The primary "acceptance criteria" here are substantial equivalence to the predicate device and compliance with recognized IEC standards. The study aims to demonstrate that its electrical characteristics and safety parameters are comparable or fall within accepted safety limits defined by these standards, despite some differences from the predicate.

2. Sample Size Used for the Test Set and Data Provenance

The document describes non-clinical tests only. There is no mention of a clinical test set involving human subjects for performance or efficacy evaluation. The "data provenance" therefore refers to the origin of engineering and safety test results, rather than clinical data.

• Sample Size: Not applicable as no clinical test set is described. The relevant "samples" would be the units of the device models (KTR-201, KTR-202, KTR-203) used for engineering and electrical testing. The exact number of units tested is not specified but is typically a small number for such compliance testing.
• Data Provenance: The tests are non-clinical (engineering, electrical, software, biocompatibility). These tests were conducted by the manufacturer (Shenzhen Kentro Medical Electronics Co., Ltd) or accredited labs. The nationality is implied to be China, where the manufacturer is located. All tests are inherently prospective as they are conducted specifically to support this 510(k) submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not applicable. As no clinical test set is described, there is no "ground truth" established by medical experts for performance or efficacy. The "ground truth" in this context would be the specifications and requirements of the relevant IEC standards (e.g., IEC60601-1, IEC60601-2-10) and FDA guidance, against which the device's electrical outputs were measured. Compliance is determined by whether the measured parameters fall within the limits set by these standards.

4. Adjudication Method for the Test Set

Not applicable. Since there's no clinical data or human assessment of primary endpoints, no expert adjudication method (like 2+1, 3+1) is described or needed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC comparative effectiveness study is a type of clinical study involving multiple readers (e.g., radiologists) evaluating multiple cases (e.g., medical images) to compare the diagnostic performance of different methods or devices. This is not applicable to a TENS device, which provides direct therapeutic electrical stimulation, not diagnostic information. The submission focuses on substantial equivalence based on technical specifications and safety standards, not comparative clinical effectiveness.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

The device itself is a standalone therapeutic device; it is not an algorithm that requires human input to interpret its output in the same way an AI-powered diagnostic tool would. Its "standalone performance" is implicitly demonstrated through the non-clinical tests (electrical output, safety, software validation) showing it meets its design specifications and relevant standards. The device is intended for over-the-counter (OTC) use by consumers without professional human-in-the-loop operation, reflecting its standalone nature.

7. The Type of Ground Truth Used

The "ground truth" for this device's acceptance is:

• Engineering/Performance Specifications: The device's own design specifications for output parameters (voltage, current, frequency, pulse duration, waveform).
• Voluntary Consensus Standards: The requirements and limits defined by international standards such as IEC 60601-1 (general safety), IEC 60601-1-11 (home healthcare environment), IEC 60601-2-10 (nerve and muscle stimulators), and IEC 60601-1-2 (EMC). For biocompatibility, ISO 10993-5 and ISO 10993-10 for the electrode patches.
• Predicate Device Characteristics: The established safety and effectiveness profile of the legally marketed predicate device (K133929), used as a benchmark for substantial equivalence.

There is no pathology or outcomes data from a clinical trial presented as ground truth.

8. The Sample Size for the Training Set

Not applicable. This device is an electrical stimulation device, not an AI/machine learning 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 is used for this type of device.

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