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Interferential stimulation indications

• Relieve acute pain .
• Relieve and manage chronic pain .

Muscle stimulation indications

• Relax muscle spasms .
• Prevent or retard disuse atrophy
• Maintain or increase range of motion ●
• . Increase local blood circulation
• Re-educate muscle .
• Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis .

The RS-4i Plus is 4 channel electrical stimulator that incorporate traditional muscle stimulation and interferential current stimulation modalities into a single unit. It has the capability to program the device's output by the care giver to match the patient's condition through the use of pre-set selections. The RS-4i Plus is hand held with an electronic display, digital single processor, software/firmware controlled functions, user keypad, cable leads and electrode pads, multiple output channels, removable, rechargeable battery, and patient data files and retrieval capability.

The provided text describes a 510(k) summary for the RS-4i Plus Sequential Stimulator. It outlines the device's intended use, technological characteristics, and its substantial equivalence to a predicate device. However, the document does not contain explicit acceptance criteria or a study that specifically proves the device meets such criteria in terms of clinical performance metrics like accuracy, sensitivity, or specificity.

Instead, the submission focuses on demonstrating substantial equivalence based on technological characteristics and compliance with safety and performance standards. The "study" mentioned is primarily a series of tests to confirm the device's basic unit characteristics and output specifications, ensuring it performs equivalently to the predicate and meets relevant electrical, mechanical, and software safety standards.

Here's an attempt to answer your questions based on the provided text, recognizing the limitations:

1. Table of acceptance criteria and the reported device performance

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

The document does not mention a "test set" in the context of clinical or diagnostic performance data. The testing described pertains to engineering and safety standards, likely performed on a limited number of devices during development and verification. There is no mention of human subject data, country of origin, or retrospective/prospective study design for performance.

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

Not applicable. The "ground truth" here is compliance with engineering and safety standards, which would be assessed by qualified engineers and testers, not clinical experts establishing a diagnosis.

4. Adjudication method for the test set

Not applicable. There is no clinical test set requiring adjudication in the context of this 510(k) summary.

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 sequential stimulator, not an AI-powered diagnostic or assistive tool for human readers.

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

Not applicable. This device is an electrical stimulator, not an algorithm. Its performance is inherent to its physical and functional output.

7. The type of ground truth used

The "ground truth" implied for this submission is adherence to recognized international and national standards for medical electrical equipment safety, electromagnetic compatibility, software life cycle, and physical/environmental resilience, as well as demonstrating that its output specifications match those of the predicate device.

8. The sample size for the training set

Not applicable. This device is not an AI/machine learning product and does not have a "training set" in that context.

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

Not applicable.

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