(156 days)
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
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Technological Equivalence to Predicate Device (RS-4i) | RS-4i Plus is "equivalent to the RS-4i" in basic unit characteristics and output specifications. |
| Compliance with Electrical Safety Standards | Conforms to: ANSI/AAMI ES60601-1:2005, IEC 60601-1-2, IEC 601-2-10, IEC 60601-1-11 |
| Compliance with Software Life Cycle Standards | Conforms to: ANSI/AAMI/IEC 62304:2006 |
| Compliance with Electromagnetic Compatibility (EMC) | Conforms to: IEC 60601-1-2 Edition 3:2007-03 |
| Compliance with Mechanical/Environmental Standards | Conforms to: IEC 60529 (IP code), ASTM E171, D4332, D5276, D4728 |
| Functional Equivalence of Intended Use/Indications for Use | "Both devices [RS-4i Plus and RS-4i] have the same intended use/indications for use and the same fundamental scientific technology." |
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.
§ 890.5850 Powered muscle stimulator.
(a)
Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.(b)
Classification. Class II (performance standards).