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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. Mode 1,3,4,5,6
PMS (Powered Muscle Stimulation): It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance. Mode 2,6

The subject device MSLS60F is a Transcutaneous Electrical Nerve Stimulator (TENS) and Powered Muscle Stimulator (PMS), intended for the over-the-counter use to temporarily relieve pain and stimulate muscle in different body areas. This double-channel subject device, which is compact, portable, effectively transfer programmed electrical pulses directly through the self-adhesive electrodes to the suggested area of the body where the electrodes are placed. It delivers a gentle electrical pulse through the connecting wires and electrode pads to the user's skin for pain relief and muscle stimulation. The subject device has 6 operation modes which can give certain electrical pulse through the 4 pcs of electrodes placed on the skin to help users to enjoy body stimulation. The subject device has the operating elements of ON/OFF Switch, Display screen, Mode Selection key and Intensity Modification keys. The LCD display screen can show selected mode, output intensity of the pulse, and time remaining of an application mode. The subject device could be easily operated through its toggle switch or buttons to manually realize its functions according to the need of users. The subject device is equipped with accessories of the electrodes, lead wires, AC adapter and USB cable. The lead wire is used to connect the electrodes to the main unit; the USB cable is used to connect the AC adapter to the main unit when charging the built-in Li battery; the pads holders are used to storage the electrodes after therapy treatment for the convenience. The self-adhesive electrodes are important accessories of the subject device, and are contact with the skin surface. It is consists of gel, carbon film, cloth backing ,and electrode connector. The electrode is complying with the biocompatibility standards ISO 10993-5 (Cytotoxicity) and ISO 10993-10 (Irritation and Sensitization).

The document describes the acceptance criteria and study for the MSLS6QF TENS/PMS Device, establishing its substantial equivalence to a predicate device (IQ Technologies, K131290).

1. Table of Acceptance Criteria and Reported Device Performance:

The primary acceptance criteria for this 510(k) submission are based on demonstrating "substantial equivalence" to a legally marketed predicate device (IQ Technologies, K131290). This is achieved by comparing technical characteristics, specifications, and intended use, and complying with relevant voluntary standards.

Notes from the document:

• Note 1 (Patient Leakage Current): Predicate device info not publicly available, but subject device passed IEC 60601-1 tests.
• Note 2 (Weight, Dimensions, Housing Materials): Differences are small and insignificant, not raising safety/effectiveness issues.
• Note 3 (Output Voltage, Current, Pulse Width, Frequency): Differences are insignificant and do not raise new safety/effectiveness issues.
• Note 4 (Maximum Phase Charge): Differences are insignificant and do not raise new safety/effectiveness issues, and the max value does not exceed safety limits.
• Note 5 (Current Density, Average Power Density): Subject device values do not exceed safety limits and passed IEC 60601-2-10 tests. Predicate device public data for some parameters (e.g., max avg power density @ 500Ω) are similar and both are below 250mW/cm².

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

The document describes non-clinical tests performed to validate the design and assure conformance with voluntary standards. It explicitly states: "The subject device does not conduct, nor rely upon, clinical tests to determine substantial equivalence." Therefore, there is no patient test set as described in the question, but rather engineering and bench testing against recognized standards.

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

Since no clinical test set was used, no experts were involved in establishing ground truth for patient data. The "ground truth" for the device's performance was established by compliance with the referenced voluntary standards (IEC, ISO).

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

Not applicable, as no clinical test set requiring expert adjudication was used.

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/PMS device, not an AI-powered diagnostic imaging device. 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 standalone TENS/PMS device; the concept of "algorithm only" performance in the context of AI does not apply. Its performance is evaluated through compliance with electrical and biocompatibility standards.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for the device's safety and effectiveness is established through adherence to voluntary industry standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10, ISO 10993-5, ISO 10993-10) and FDA guidance for software, demonstrating that its performance parameters fall within acceptable bounds and are substantially equivalent to a cleared predicate device.

8. The sample size for the training set:

Not applicable. This device is not an AI/machine learning product and does not involve training sets.

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

Not applicable, as there is no training set.

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