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To be used for temporary relief of pain associated with sore and aching muscles in the upper and lower back due to strain from exercise or normal household work activities (Choose Mode A, B, or C)

To be used for temporary relief of pain associated with sore and aching muscles in the upper extremities (Arms) due to strain from exercise or normal household work activities (Choose Mode A, B or C)

To be used for temporary relief of pain associated with sore and aching muscles in the lower extremities (Legs) due to strain from exercise or normal household work activities (Choose Mode A, B or C)

To be used for symptomatic relief and management of chronic, intractable pain associated with Arthritis (Choose Mode A)

To stimulate healthy muscles in order to improve and facilitate muscle performance (Choose Mode B)

The Pain Therapy System, Model PTS-II is a selectable dual channel TENS and EMS device operated by DC 3.0V (AAA*2 batteries). It is made up of one main unit, two electrode cables, and two pairs of electrode pads.

There are 3 selectable, pre-programmed output waveforms (modes) to choose from. The two channels share one knob to adjust, the intensity are adjustable from 0 to 5. Running time can be selected among 10, 20 or 40min and recycled. There is a dial with on/off on the side that enables the device to be turned on or off, and it can be used to adjust the output intensity level, turn clockwise to increase intensity and turn anticlockwise to decrease the intensity. In the front of the device, there are 2 buttons and 6 indicator lights, in which one button is the mode selection button, and the other is for time selection. There are three modes A. B. C. respectively indicated by three indicator lights, which are on the right of the mode selection button. The device has 3 timing levels, namely 10, 20, 40 min, and indicated by three indicator lights, which are on the right of the timing selection button.

The provided document is a 510(k) premarket notification from the FDA for a device called "Pain Therapy System, Model PTS-II". It describes the device, its intended use, and a comparison to a predicate device to establish substantial equivalence.

Crucially, this document is for a Transcutaneous Electrical Nerve Stimulator (TENS) device, not an AI/ML medical device. Therefore, the concepts of "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of an AI/ML device (e.g., performance metrics like accuracy, sensitivity, specificity, or reader studies) are not applicable here. The substantial equivalence for this TENS device is established through non-clinical testing against recognized consensus standards and a comparison of technological characteristics with a legally marketed predicate device.

The questions you've asked (about sample sizes, ground truth experts, MRMC studies, standalone performance, training sets, etc.) are highly relevant to the evaluation of AI/ML medical devices. However, they do not apply to the traditional medical device evaluation process exemplified by this 510(k) submission for a TENS device.

Here's a breakdown of what is relevant from the document regarding its "acceptance criteria" (which are more accurately "conformance criteria" in this context) and "proof":

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

Instead of acceptance criteria for AI performance, the document lists technological characteristics of the proposed device and compares them to the predicate device. The "acceptance criteria" here are essentially that the proposed device's characteristics are sufficiently similar to the predicate device, or any differences do not raise new questions of safety or effectiveness.

The "reported device performance" is essentially the demonstrated compliance with the listed consensus standards and the presentation of these technological parameters. The conclusion (Page 8) states: "bench testing and safety report documentation demonstrate that the submitted device could maintain the same safety and effectiveness as that of predicate device."

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

• Not applicable. This isn't a study involving human subjects or data sets in the AI/ML sense. The "testing" refers to bench testing and compliance with electrical safety and performance standards.
• The device is manufactured by "Counter Scientific Development (GZ) Ltd" in Guangzhou, 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. Ground truth in the AI/ML context is not relevant for this type of device submission. The "ground truth" here is the adherence to established engineering and safety standards.

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

• Not applicable. No adjudication in the AI/ML context.

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. No MRMC study. This is a physical device, not an AI assistance tool for human readers.

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

• Not applicable. Not an algorithm. The "standalone performance" is the device's ability to meet its operational specifications and safety standards on its own.

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

• Not applicable. The "ground truth" for this device's evaluation is compliance with recognized consensus standards (ANSI/AAMI ES60601-1, IEC 60601-2-10, IEC 60601-1-2) which define safety and essential performance parameters, and the comparison of its technical specifications to a predicate device.

8. The sample size for the training set

• Not applicable. No training set for an AI/ML model.

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

• Not applicable. No training set.

In summary, the provided document details a 510(k) submission for a non-AI medical device (TENS). The evaluation methodology relies on comparison to a predicate device and compliance with established electrical and safety standards, rather than the AI/ML-specific testing and evaluation criteria you've outlined.

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