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Temporary relief of pain associated with sore and aching muscles in the lower back due to strain from exercise or normal household and work activities.

The Rhythm Touch Q 2-Way is a dual channeled powered nerve stimulator. It electronically stimulates nerves. It comprises two main components, namely, an electronic stimulatory module which generates the required stimulation signals, and skin electrodes with lead wires.

The product is supplied with two sets of electrodes, a belt to fix and hold the unit and the electrodes, an instruction manual, and a set of batteries. Power is derived from two AAA cells located in a compartment protected by a removable battery cover.

The electrodes provided with this model have 510(k) clearance. They are rectangular, 1.5"x1.75" in size. The lead wires also have 510(k) clearance.

The provided text is a 510(k) Summary for the Rhythm Touch Q 2-Way, a transcutaneous electrical nerve stimulator (TENS) for pain relief.

The acceptance criteria and study information typically found in a detailed clinical performance study report are not present in the provided document. The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device rather than presenting a de novo performance study with specific acceptance criteria, sample sizes, expert ground truth, or MRMC studies.

Here's a breakdown based on the information provided and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

• Acceptance Criteria: Not explicitly stated in the document. For a TENS device, acceptance criteria would typically relate to safety (e.g., electrical safety standards, biocompatibility of materials) and effectiveness (e.g., measurable reduction in pain scores in a clinical trial).
• Reported Device Performance: The document states, "The Rhythm Touch Q 2-Way and the predicate device have similar technological characteristics. The Rhythm Touch Q 2-Way does not pose any new or different safety hazards, and the devices are substantially equivalent." This implies that its performance is considered equivalent to the predicate device (BIOSTIM KIT, K050174), which is legally marketed for similar indications. No specific performance metrics are reported for the Rhythm Touch Q 2-Way device itself.

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

• Not applicable/Not provided. This document is a 510(k) summary for substantial equivalence. It does not describe a clinical performance study with a "test set" in the context of AI/machine learning or detailed clinical trials. The basis for clearance is similarity to a predicate, not new clinical performance data from a specific test set.

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

• Not applicable/Not provided. Ground truth determination by experts is relevant for studies evaluating diagnostic or prognostic devices, especially those using image analysis or complex data interpretation. This TENS device does not fall into that category, and no such study is described.

4. Adjudication method for the test set

• Not applicable/Not provided. As no test set and expert review are described, no adjudication method is relevant.

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

• No. This product is a transcutaneous electrical nerve stimulator, not an AI-powered diagnostic or interpretive device. Therefore, MRMC studies involving AI assistance for human readers are not relevant and were not performed or reported.

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

• Not applicable/Not provided. This is a hardware medical device (TENS unit), not an algorithm or software. Its mechanism of action is electrical stimulation, independent of human interpretation or AI algorithms.

7. The type of ground truth used

• Not applicable/Not provided. The concept of "ground truth" as typically applied in AI/diagnostic studies (e.g., pathology, outcomes data) is not relevant for demonstrating substantial equivalence of a TENS device. The "ground" for comparison is the predicate device's established safety and effectiveness.

8. The sample size for the training set

• Not applicable/Not provided. This is a hardware device cleared through substantial equivalence, not an AI/machine learning model that requires a training set.

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

• Not applicable/Not provided. As there is no training set for an AI model, there is no ground truth to establish for it.

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