(99 days)
Specific indications: used to apply an electrical current to electrodes on patient's skin to function as:
- Relaxation of muscle spasms
- Prevention or retardation of disuse atrophy ●
- . Muscle re-education
- Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
- . Maintaining or increasing range of motion
A sequenced system for transcutaneous muscle stimulation consists of a stimulator, a sequencer for channel selection, patient cable, and electrodes applied to the skin.
Various types of waveforms may be output to generate the desired effect on the muscle(s) to be treated, and the patient is given control of the signal intensity for personal safety and comfort. Sequenced system may have more than on output channel in order to operate bilaterally on the body or to treat multiple regions simultaneously or serially in a prescribed sequence.
The provided document is a 510(k) summary for the EVERLIFE Powered Muscle Stimulator. It outlines the device's intended use and the non-clinical tests performed. However, it explicitly states that no clinical tests were submitted. Therefore, there is no information available to describe acceptance criteria based on clinical performance or a study proving the device meets such criteria.
The substantial equivalence decision for this device was based on comparison to legally marketed predicate devices and non-clinical testing, not on clinical performance criteria.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Not applicable/Not provided. The document does not specify quantitative acceptance criteria for device performance based on clinical outcomes or a study proving it meets such criteria. The "Conclusion" section states that the device is "as safe and effective as, and the function in a manner equivalent to the predicate devices" based on product description and non-clinical tests.
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. No clinical test set or data provenance is mentioned as no clinical studies were submitted. Non-clinical testing was performed on the device itself.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. No clinical test set requiring expert ground truth was performed or submitted.
4. Adjudication Method for the Test Set
Not applicable. No clinical test set was performed or submitted.
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 Powered Muscle Stimulator, not an AI-assisted diagnostic tool. No MRMC study was performed.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is a Powered Muscle Stimulator, not an algorithm. The non-clinical tests were performed on the device and its accessories, indicating device-alone performance in terms of safety and waveform output.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
Not applicable. No clinical ground truth was established as no clinical studies were submitted. The "ground truth" for the non-clinical testing would be the defined safety standards and specified waveform outputs, confirmed through laboratory measurements.
8. The Sample Size for the Training Set
Not applicable. No training set for an algorithm is mentioned as this is a physical medical device, not an AI/algorithm-based product.
9. How the Ground Truth for the Training Set Was Established
Not applicable. No training set is mentioned.
§ 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).