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TENS:
PL-029K29, PL-029K30, and PL-029Q are used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, arm, and leg, due to strain from exercise or normal household and work activities.
PL-029K29, PL-029K30, and PL-029Q are also intended for symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.

PMS:
PL-029K29, PL-029K30, and PL-029Q are used to stimulate healthy muscles in order to improve and facilitate muscle performance. To be used for the improvement of muscle tone and for strengthening muscles in the arms, abdomen. legs, and buttocks. Not intended for use in any therapy or for the treatment of any medical conditions or diseases.
PL-029K29, PL-029K30, and PL-029Q are also intended to temporarily increase local blood circulation in the healthy muscles of lower extremities.

Heating:
PL-029K30 and PL-029Q is intended for temporary relief of minor aches and pains.

The subject device delivers electric pulses generated to the user's body areas such as the back and foot through the electrodes. The devices include operating elements, such as the ON/OFF button, intensity increase button, and intensity decrease button, and could be attached to electrodes. The device has multiple program modes of different pulse frequencies, covering TENS and PMS that is also called Electrical Muscle Stimulation (EMS). the device may also provide heat for temporary relief of minor aches and pains.
The device could be easily operated through its buttons to manually realize its functions, such as turning on/off and increasing/decreasing intensity, providing heat/light if needed. The optional wireless control via a remote or Bluetooth APP could provide a secondary operation way to the user, who could be able to wirelessly realize the functions mentioned above.
The electrodes cleared include the electrode patches/pads and electrode garments, which could be packaged together with the 510(k)-cleared devices or packaged separately as the replacement electrodes for 510(k)-cleared devices. The exact percentage of ingredients (such as lidocaine, menthol, and/or cannabidiol) used in the biocompatible electrodes is withheld as the trade secret and may be disclosed as requested.

The provided text is a 510(k) Summary for the StimPlus Patch, a Transcutaneous Electrical Nerve Stimulator (TENS) and Powered Muscle Stimulator (PMS) with heating function. The document focuses on demonstrating that the subject device is substantially equivalent to legally marketed predicate devices, not on proving that the device meets specific acceptance criteria through a clinical study involving human patients.

Therefore, many of the requested details about acceptance criteria, study design, expert involvement, and ground truth establishment (especially pertaining to clinical performance) cannot be extracted from this document because the submission method relies on demonstrating substantial equivalence to pre-existing, cleared devices rather than a de novo clinical performance study.

However, I can extract the information related to the non-clinical tests and the comparison of the device's technical specifications to those of its predicates, which serve as a form of "acceptance criteria" for demonstrating substantial equivalence.

Here's the breakdown of what can and cannot be answered based on the provided text:

1. A table of acceptance criteria and the reported device performance

The acceptance criteria for this 510(k) submission are based on demonstrating "substantial equivalence" to predicate devices. This is achieved by showing that the subject device has the same intended use and similar technological characteristics, or that any differences do not raise new questions of safety or effectiveness. The core of this is the comparison table of technical parameters.

Table: Comparison of Subject Device (StimPlus Patch) to Predicate Devices

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This document does not describe a clinical test set or data provenance in the context of human trials for the StimPlus Patch. The "tests" performed are non-clinical, focusing on electrical safety, EMC, and biocompatibility of the device itself. Data provenance for such tests is typically not a concern in the same way as it is for clinical data. The submitter is JKH Health Co., Ltd. from Shenzhen, China.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This is a 510(k) submission based on substantial equivalence and non-clinical testing. There is no mention of "experts" establishing ground truth for a clinical test set in the document.

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

Not applicable. There is no clinical test set described that would require an adjudication method.

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 unit, not an AI-assisted diagnostic imaging tool. No MRMC study was conducted or reported.

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

Not applicable. This device is a physical electrostimulation device, not an algorithm.

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

For the non-clinical tests, the "ground truth" is adherence to recognized voluntary standards (e.g., IEC 60601-1, ISO 10993 series) and the technical specifications of the predicate devices. There is no clinical "ground truth" (like pathology or outcomes data) mentioned for the StimPlus Patch's performance.

8. The sample size for the training set

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

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

Not applicable. This device is not an AI/ML algorithm.

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