(330 days)
Indication Use For EMS (Code 10, 20-22,30-33_) Only 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 Indication Use For IF (Code 11-18, 20-22,30-33) For symptomatic relief and management of chronic pain and /or as an adjunctive treatment in the management of post -surgical and post-traumatic acute pain. Powered muscle stimulators should only be used under medical supervision
The SDS-41 like a number of legally marketed predicate devices incorporates traditional muscle stimulation and interferential current stimulation modalities into one unit. The SDS-41 is housed in a plastic enclosure. The front of the enclosure house character LCD display. The accessories provided with the SDS-41 include the output cable, the electrode pads, and the AC Charging Adapter. The SDS-4I muscle stimulation modality operates at a specified 23 volts max (into a 500 ohm load) and 46mA max (into a 500 ohm load) with a pulse width of 520us Max and a cycle frequency of 75 Hz (±5%). The pulse is Symmetrical bi-phasic. The waveform includes an on/off ramp, which slowly increases the pulse width to the desired setting. The SDS-4I interferential modality operates at a specified 80 mA max (into a 500 ohm load). The carrier and interferential signals are sine wave symmetric, balanced outputs with zero net charge. The interferential modality can operate in a true interferential mode (4 pad mode) or the signals can be pre-mixed and only the pre-mixed signals sent to the patient (2 pad mode). The interference Signal frequency can be fixed (continuous) or carried based on three selections (variable).
This document is a 510(k) summary for the SDS-4I Muscular and Interferential Current Stimulator. It describes the device, its indications for use, and its substantial equivalence to previously marketed devices. However, it does not contain information about acceptance criteria, a specific study proving the device meets those criteria, or details regarding ground truth, expert adjudication, or sample sizes related to performance evaluation.
Therefore, for the requested information, the response is as follows:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not specified in the provided document.
- Reported Device Performance: Not specified in the provided document.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not specified in the provided document.
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 specified in the provided document.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not specified in the provided document.
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
- This document describes a muscle stimulator device, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC comparative effectiveness study involving AI assistance for human readers is not applicable and not mentioned.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- This document describes a muscle stimulator device, not an algorithm. Therefore, standalone algorithm performance is not applicable and not mentioned.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc.)
- Not specified in the provided document. The document pertains to a medical device for muscle stimulation and interferential current, not an diagnostic or AI-driven system that would typically require "ground truth" in the context of diagnostic accuracy.
8. The sample size for the training set
- Not specified in the provided document.
9. How the ground truth for the training set was established
- Not specified in the provided document.
§ 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).