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The WL-2405K+ is a digital electrical and heat stimulator for active treatment application as the following:

TENS can be used for the following applications:

• 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 and work activities.

EMS can be used for the following applications:

• For healthy adults for the stimulation of healthy muscles in order to improve or facilitate muscle performance.

Heat Mode:

• Heat can be used for temporary relief of minor aches and pains.

Well-Life OTC TENS/EMS/Heating Stimulator Device, Model no. WL-2405K* provides a combination of transcutaneous electrical nerve stimulation (TENS) for temporary relief of pain associated with sore and aching muscles due to strain from exercise, normal household chores and work related activities, Electrical Muscle Stimulator (EMS) can be used to stimulate healthy muscles in order to facilitate muscle performance, relax muscle spasms, prevent or retard disuse atrophy, reeducate muscles and to maintain or increase the range of motion, Heat can be used in warming the muscle for soothing comfort.

The stimulator generates the output current specified as the input of controller. The output port transmits the output current & heat to the electrode, which is attached to the user's skin ; ; with the combination of the main device parts, the device can be placed on the treatment locations as recommended in the user manual for temporary relief of pain associated with sore and aching muscles in the low back, upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities, and to be used to stimulate healthy muscle in order to improve and facilitate muscle performance.

The device includes several operating elements, such as the ON/OFF button, intensity increase button, and intensity decrease button, and could be attached and detached to electrodes. The device has multiple program modes of different pulse frequencies, covering TENS/EMS and heat. While used in the heating mode, the device is coupled with electronically controlled electrodes to provide automatic thermal heat to the skin with the maximum temperature of 43°C.

For the heating cycle, the temperature will get to 43 degree Celsius in 130 seconds after turning on the heating mode, and when it reaches 43 degree Celsius then it will cool down to body temperature for 20 seconds, then back to 43 degree Celsius for 20 seconds , the cycle will continue for 15 minutes.

The device could be operated through its buttons to manually realize its functions, such as turning on/off and increasing/decreasing intensity, providing heat/temperature. Channel 1 can provide electrical stimulation signal, such as TENS/EMS, and it can only be performed by connecting an electrode and wire dedicated to electrical stimulation. Channel 2 can provide heat treatment, and it can only be carried out by connecting heat-exclusive electrode and wires. The exclusive accessories used for electrical stimulation or thermotherapy are marked by color to prevent misuse by the user. If you accidentally use it incorrectly, there will be a protective mechanism in the device to prevent it from operating and causing harm.

Based on the provided text, the device in question is the "Well-Life TENS/EMS/Heating Stimulator (Model: WL-2405K+)". This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific clinical acceptance criteria through a clinical study with detailed performance metrics.

Therefore, much of the information typically requested for demonstrating device performance against acceptance criteria in a clinical study (like sample size for test sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, ground truth types, training set details) is not applicable or not provided in this type of submission. This summary primarily relies on non-clinical testing (bench testing, usability, biocompatibility, electrical safety, shelf life, software validation) and direct comparison to predicate devices, asserting equivalence in safety and effectiveness.

Here's a breakdown of what can be extracted and what is not present:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the standards the device claims to meet and the performance benchmarks of the predicate devices. However, explicit numerical acceptance criteria and direct performance results are primarily presented for non-clinical tests rather than clinical outcomes.

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

• Test Set Sample Size: Not applicable. No clinical test set data is provided or mentioned as being used for substantial equivalence. The "test sets" mentioned refer to non-clinical bench testing.
• Data Provenance: Not applicable for clinical data. For non-clinical tests, tests were conducted at an "accredited test laboratory" (location not specified beyond Taiwan for the manufacturer).

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

• Not applicable. No external "experts" were used to establish ground truth as no clinical test set requiring human interpretation for ground truth was performed or presented. The "ground truth" for the non-clinical tests is based on the specifications of the standards (e.g., IEC, ISO, ASTM).

4. Adjudication Method for the Test Set

• Not applicable. No clinical test set involved human readers or ground truth requiring adjudication.

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

• No. The document explicitly states: "No clinical test data was used to support substantial equivalence." (Page 10, Section 9.1). Therefore, no MRMC study was performed.

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

• Not applicable. This device is a physical stimulator, not an AI algorithm. Its performance is related to its electrical and heating outputs and physical characteristics.

7. The Type of Ground Truth Used

• For Non-Clinical Tests: The "ground truth" is established by adherence to recognized voluntary consensus standards (e.g., IEC 60601-1, IEC 60601-2-10, ISO 10993 series, ASTM F1980-16, FDA guidances for software and shelf life). These standards define the acceptable range or performance for various parameters.
• For Substantial Equivalence: The primary "ground truth" is the performance and indications of the legally marketed predicate devices. The claim is that the subject device is similar enough in terms of safety and effectiveness.

8. The Sample Size for the Training Set

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

9. How the Ground Truth for the Training Set Was Established

• Not applicable. As above, no training set for an algorithm.

Summary of the Study:

The "study" that proves the device meets the acceptance criteria is primarily a non-clinical evaluation documented in the "Non-Clinical Testing Summary" (Section 9) and a comparison to predicate devices for substantial equivalence (Section 10). The manufacturer performed:

• Usability Testing: To meet IEC/EN 60601-1-6 and IEC/EN 62366 standards.
• Biocompatibility Testing: Covering cytotoxicity, sensitization, and irritation, in compliance with ISO 10993 standards. It leverages the fact that the electrode is identical to one cleared in a predicate device.
• Electromagnetic Compatibility and Electrical Safety Testing: To meet IEC 60601-1, IEC 60601-1-11, and ANSI/AAMI ES 60601-1 standards, and Li-ion battery safety.
• Performance Testing: To meet the IEC 60601-2-10 standard for nerve and muscle stimulators.
• Shelf Life Testing: Following FDA guidance and ASTM F1980-16.
• Software Validation: Following FDA guidance on software for medical devices.

The entire submission is geared towards demonstrating substantial equivalence to existing predicate devices (HIVOX OTC Electrical Stimulator K203574 and Otc combo tens/ems system K172809) based on these non-clinical tests and a detailed comparison of technical specifications, rather than new clinical trials with patient outcomes. The premise of a 510(k) is that if a new device is as safe and effective as a legally marketed predicate device, it does not require a new PMA (Premarket Approval) process which typically involves extensive clinical data.

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