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TENS(Transcutaneous Electric Nerve Stimulation):

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. PMS(Powered Muscle Stimulation):

It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.

Muscle Stimulator is a portable and DC 3.7V battery powered multifunction device, offering both Transcutaneous Electrical Nerve Stimulation (TENS) and Powered Muscle Stimulation (PMS) qualities in one device.

Muscle Stimulator can give certain electrical pulses through electrode adhesive pads to the suggested area of the body where the electrodes are placed. The electrodes to be used with the device have already been cleared under K182111.

The electronic stimulatory module has the operating elements of an On/Off Switch, Intensity buttons, Output channel buttons, T button, Output ports, and USB port for battery charging.

The LCD display screen can show time remaining of an application program, battery power, program icons, output channel and intensity, etc.

The device is equipped with accessories of electrode pads, electrode cables, a battery charger, and one USB cable. The electrode cables are used to connect the device; the USB cable is used to connect the charger and the built-in lithium battery. All accessories, including USB cables, electrode pads, electrode cables, chargers can only be changed or replaced by a qualified person.

This document is a 510(k) Premarket Notification from the FDA regarding a Muscle Stimulator device. It does not contain information about an AI/ML device or a study involving acceptance criteria for such a device against ground truth.

The document primarily focuses on demonstrating substantial equivalence of the new Muscle Stimulator device (YR-U80-PRO-MAX, YR-U80-PRO, YR-U8-PRO, YR-U8) to existing predicate devices (K143268 and K121719). The document details:

• Device Description: A portable, DC 3.7V battery-powered multifunction device offering both Transcutaneous Electrical Nerve Stimulation (TENS) and Powered Muscle Stimulation (PMS).
• Indications for Use: Temporary pain relief (TENS) and stimulating healthy muscles to improve/facilitate performance (PMS).
• Comparison to Predicate Devices: A detailed table comparing various technical parameters (e.g., power source, output modes, waveforms, electrical characteristics) of the new device with the predicate and reference devices.
• Non-Clinical Testing: Conformance to various electrical safety and performance standards (e.g., AAMI/ANSI ES60601-1, IEC 60601-2-10, IEC 60601-1-2, IEC 62133-2, IEC 60601-1-11).
• Clinical Testing: Explicitly states, "No clinical testing was performed on the device."

Therefore, based on the provided text, I cannot extract the information required to answer your questions about acceptance criteria for an AI/ML device, ground truth establishment, sample sizes, or expert adjudication, as these topics are not discussed in the context of this device's submission.

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TENS (Transcutaneous Electric Nerve Stimulation):
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.
PMS (Powered Muscle Stimulation):
It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.

TENS and Muscle Stimulator is a portable and DC 3.7V battery powered multifunction device, offering both Transcutaneous Electrical Nerve Stimulation (TENS) and Powered Muscle Stimulation (PMS) qualities in one device.
TENS and Muscle Stimulator can give certain electrical pulses through electrode adhesive pads to the suggested area of the body where the electrodes are placed. AS8012 has 20 operation programs and AS8015 has 24 operation programs.
The electronic stimulatory module has the operating elements of an On/Off Switch, LCD display screen, Intensity buttons, Output channel buttons, T button, Output ports, and USB port for battery charging,etc.
The LCD display screen can show time remaining of an application program, battery power, program icons, output channel and intensity,etc.
The device is equipped with accessories of electrode pads, electrode cables a battery charger, and one USB cable. The electrode cables are used to connect the pads to the device; the USB cable is used to connect the charge and the built-in lithium battery. All accessories, including USB cables, electrode pads, electrode cables, chargers can only be changed or replaced by a qualified person.

The provided text is a 510(k) summary for a TENS and Muscle Stimulator device. It details the device's technical specifications and compares them to two predicate devices to demonstrate substantial equivalence, rather than providing a study proving a device meets specific acceptance criteria.

As such, the document does not contain information about the acceptance criteria and the study that proves the device meets those criteria in the way typically required for AI/ML-based medical devices or diagnostic devices that require performance evaluation against clinical ground truth.

The provided text focuses on electrical safety and performance standards for a TENS and Muscle Stimulator, which are typically assessed through bench testing, not clinical studies with "acceptance criteria" related to diagnostic accuracy, sensitivity, specificity, etc., or human reader improvement with AI assistance.

Therefore, I cannot extract the requested information regarding:

1. A table of acceptance criteria and the reported device performance: This document lists technical specifications and compliance with electrical safety standards, not diagnostic performance metrics.
2. Sample size used for the test set and the data provenance: Not applicable here, as it's not a performance study on a test set of patient data.
3. Number of experts used to establish the ground truth and qualifications: Not applicable.
4. Adjudication method for the test set: Not applicable.
5. MRMC comparative effectiveness study or effect size: Not applicable.
6. Standalone (algorithm only) performance: Not applicable.
7. Type of ground truth used: Not applicable.
8. Sample size for the training set: Not applicable (not an AI/ML device in the context of this document).
9. How the ground truth for the training set was established: Not applicable.

What the document does provide in terms of "acceptance":

The document demonstrates that the new device meets electrical safety and performance standards the FDA considers essential for this type of device to be "substantially equivalent" to legally marketed predicate devices. The "acceptance criteria" in this context are primarily the successful completion of tests according to the following voluntary standards:

• ANSI AAMI ES60601-1: 2005/(R)2012 And A1:2012, C1:2009/(R)2012 And A2:2010/(R)2012 (Consolidated Text) Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance (IEC 60601-1:2005, MOD): General safety requirements.
• IEC 60601-2-10 Edition 2.1 2016-04, Medical Electrical Equipment - Part 2-10: Particular Requirements For The Basic Safety And Essential Performance Of Nerve And Muscle Stimulators: Specific safety and performance requirements for nerve and muscle stimulators.
• ANSI AAMI IEC 60601-1-2:2014, Medical Electrical Equipment -- Part 1-2: General Requirements For Basic Safety And Essential Performance -- Collateral Standard: Electromagnetic Disturbances --Requirements And Tests: Requirements for electromagnetic compatibility.
• IEC 62133-2 Edition1.0 2017-02 Secondary Cells And Batteries Containing Alkaline Or Other Non-Acid Electrolytes - Safety Requirements For Portable Sealed Secondary Cells, And For Batteries Made From Them, For Use In Portable Applications - Part 2: Lithium Systems: Battery safety.
• IEC 60601-1-11 Edition 2.0 2015-01, Medical Electrical Equipment - Part 1-11: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Requirements For Medical Electrical Equipment And Medical Electrical Systems Used In The Home Healthcare Environment: Requirements for home healthcare use.

The statement "The conclusion drawn from the safety testing is that the new devices are substantially equivalent to the predicate devices. Furthermore, the new devices comply with the recognized standards and perform its intended tasks as well as the legally marketed predicate devices." serves as the proof of compliance with these "acceptance criteria" (i.e., meeting the requirements of the cited standards).

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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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