(111 days)
As prescribed by a physician for the following:
Relaxation of muscle spasm
Increasing local blood circulation
Maintaining or increasing range of motion
Preventing or retarding disuse atrophy
Muscle re-education
Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis.
The GS 3000 is a High Voltage Pulsed Galvanic Current (HVPGC) Stimulator which delivers stimulation by applying an electrical current to electrodes, which are attached on the patient's skin. The device has a twin peak monophasic waveform with a 5 usec fixed duration. The current Amplitude is adjustable from 0-350 Volts (0~190V Max @ 500ohm resistance), with an adjustable pulse frequency range from 2-100 cycles per second.
The GS 3000 is a single channel device, with the option to set the active electrodes (treatment electrode) to either positive or negative polarity in relation to the dispersive electrode (closes patient circuit) and alternating or synchronous treatment mode selection. The device is powered by a 9 volt battery.
It appears this document describes a 510(k) premarket notification for a medical device called the GS 3000, which is a Powered Muscle Stimulator.
However, the provided text does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in terms of clinical performance or diagnostic accuracy. The "Discussion of performance testing" section specifically refers to:
- IEC 60601-1: General requirements for safety of medical electrical equipment. This covers electrical leakage current, electrode and lead wire safety, output current, and power density.
- IEC 60601-1-2: Collateral standard for electromagnetic compatibility.
These are engineering and safety performance standards, not clinical performance or efficacy studies. The document states that the device "met all applicable requirements" for these standards, indicating successful electrical and EMC testing.
Therefore, I cannot fill in the requested table and sections related to clinical acceptance criteria, study details, sample sizes, ground truth, or MRMC studies because this information is not present in the provided text.
The document primarily focuses on establishing "substantial equivalence" to a predicate device based on technological characteristics (output specifications, device design, waveforms) and safety standards, rather than clinical performance outcomes against defined acceptance criteria.
Based on the provided text, here is what can be extracted, and where limitations exist:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Acceptance Criteria (Not applicable/provided for clinical performance) | Reported Device Performance (as stated in the document) |
|---|---|---|
| Electrical Safety | Compliance with IEC 60601-1 (electrical leakage current, electrode/lead wire safety, output current, power density) | "met all applicable requirements" |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2 | "met all applicable requirements" |
| Technological Equivalence | Output specifications, device design, and waveforms comparable to predicate device | "demonstrated the GS 3000 to be substantially equivalent to the predicate device." |
| Clinical Performance/Efficacy | (No specific clinical performance acceptance criteria or results are provided in this document.) | (No clinical performance data is provided in this document.) |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- No information provided. The performance tests mentioned (IEC 60601-1 and IEC 60601-1-2) are engineering and safety tests, not clinical studies involving patients or a "test set" in the context of diagnostic or clinical outcome performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. There is no "test set" and no ground truth established by experts for clinical performance in this document.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable. There is no "test set" and no adjudication method described.
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. An MRMC study was not done. The device is a "Powered Muscle Stimulator," not an AI-powered diagnostic or assistive tool.
6. If a standalone (i.e., algorithm only without human-in-the loop performance) was done
- No. This is not an algorithm-based device. "Standalone performance" in this context would refer to the device's electrical output characteristics and safety, which were tested against IEC standards as mentioned.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable for clinical performance. For the engineering and safety tests, the "ground truth" would be the specifications and limits defined by the IEC standards themselves.
8. The sample size for the training set
- Not applicable. This device does not involve a "training set" as it is not an AI/machine learning device.
9. How the ground truth for the training set was established
- Not applicable. This device does not involve a "training set."
§ 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).