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TENS: The device is designed to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), lower extremities (leg), abdomen and bottom due to strain from exercise or normal household work activities. EMS: The device is designed to be used to stimulate healthy muscles in order to improve or facilitate muscle performance.

The device of the model TU3424-F is a portable, battery powered (lithium battery 3.7V DC) multifunction device offering both Transcutaneous Electrical Nerve Stimulator (TENS) and Powered Muscle Stimulator (EMS) qualities in one device, it can be used for arm, shoulder, neck, back, waist, abdomen, and leg. 4 channels that effectively transfer your desired choice of programmed electrical pulses directly through electrode adhesive pads to the suggested area of the body where the electrodes are placed, causing minimal muscle contractions. There are 24 modes of operations. The electrode pads are cleared by FDA, and 510(k) number is K092546 for the electrode pads. They are used as an accessory to the TENS or EMS device unit, which transmits electrical current to patient skin. The electrical current is first transmitted via the lead wire or snap button then transmitted to the conductive gel which is adhered to patient skin. The electrode pads are composed of a cover, connector lead wire or snap button, conductive carbon film, conductive hydrogel, and an electrode carrier liner. It is non-sterile and intended for single adult patient (age ≥ 18) multiple application use. Its output waveform is provided 24 programs and 20 adjustable intensity levels. The LCD screen shows the information of program, level, operating time and channel.

This is a 510(k) summary for a Transcutaneous Electrical Nerve Stimulator (TENS) & Powered Muscle Stimulator (EMS) device, indicating that its substantial equivalence to a predicate device was established based on non-clinical performance data and adherence to recognized standards. A clinical study proving acceptance criteria is not applicable for this type of submission, as the FDA has determined that clinical data is not required to demonstrate substantial equivalence for these devices.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are primarily based on demonstrating substantial equivalence to a legally marketed predicate device (K202866, Model: FM-B2403) by meeting recognized voluntary standards and confirming that performance differences do not raise new safety or effectiveness concerns.

Note: The table in the document has inconsistencies for "Number of Output Modes". The "Predicate Device" column lists "TENS:10, EMS:5" next to the new device's "TENS:19, EMS:5" but then also lists the new device's values in its own column under "New device". The interpretation above assumes the "New device" column accurately describes the proposed device and the "Predicate Device" column describes the predicate. The "SE" in the table signifies that despite these differences, the device is considered substantially equivalent.

Conclusion from document: "After analyzing non-clinical laboratory studies and safety testing data, it can be concluded that the model TU3424-F is substantially equivalent to the predicate device K202866 (Model: FM-B2403)."

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

Not applicable. This submission is for a TENS/EMS device and relies on non-clinical performance and safety testing against recognized standards to demonstrate substantial equivalence to a predicate device, rather than a clinical study with a test set of patient data.

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

Not applicable, as no clinical test set requiring expert ground truth was performed for this 510(k) submission.

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

Not applicable, as no clinical test set requiring adjudication was performed for this 510(k) submission.

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. This device is a TENS/EMS stimulator, not an AI-powered diagnostic or interpretive device, and therefore no MRMC study was performed.

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

Not applicable. This device is a physical stimulator and does not involve a diagnostic algorithm for standalone performance evaluation. Its performance is assessed through electrical safety and performance testing, and biocompatibility.

7. The type of ground truth used

The "ground truth" for this submission is established through:

• Compliance with recognized voluntary standards: ANSI/AAMI/ES 60601-1, IEC60601-1-2, IEC 60601-2-10, IEC60601-1-11, ISO10993-5, ISO10993-10. These standards define the acceptable safety and performance characteristics for such devices.
• Comparison to a legally marketed predicate device (K202866): The predicate device's established safety and effectiveness serves as a reference point.
• Non-clinical laboratory studies and safety testing data: These tests directly evaluate the device's electrical output parameters, safety features, and material biocompatibility against the requirements of the standards and comparisons to the predicate.

8. The sample size for the training set

Not applicable. This is a hardware device submission for a TENS/EMS stimulator, not an AI/machine learning algorithm, and therefore does not involve a training set.

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

Not applicable, as there is no training set for this device.

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