(267 days)
The geko™ T-1 Neuromuscular Stimulator is intended for:
- Increasing local blood circulation, and
- Immediate post-surgical stimulation of the calf muscles to prevent venous thrombosis.
The geko™ T-1 (geko™) Neuromuscular Stimulator is a disposable, fully integrated unit composed of a constant current pulse generator with embedded software and battery enclosed in an over-molded plastic casing, and a silver electrode with a hydrogel coating which provides a means of attachment of the device and electrical contact with the patient. A single button controls the On/Off function and the intensity level of the device, which is achieved through changes in the delivered pulse width. The geko™ is applied so that the electrodes lie over the common peroneal nerve behind the knee. Stimulation of the common peroneal nerve causes contraction of the calf muscles through the direct activation of the motor neurons, resulting in increased blood flow.
Here's an analysis of the provided text regarding the acceptance criteria and study for the geko™ T-1 Neuromuscular Stimulator.
It's important to note that the provided document is a 510(k) summary for a medical device, which focuses on demonstrating substantial equivalence to a predicate device rather than outright proving effectiveness through a traditional clinical trial designed around specific acceptance criteria like those for a new drug. Therefore, some of the information requested might not be explicitly stated in the context of typical "acceptance criteria" but can be inferred from the equivalence arguments.
Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of "acceptance criteria" for performance metrics in the way one might see for a diagnostic AI. Instead, it demonstrates substantial equivalence to a predicate device (SYS*STIM ME 208) by comparing various technical and functional parameters, and by showing that the device achieves similar physiological effects (increased blood flow).
The substantial equivalence argument is built around the idea that the geko™ T-1 is as safe and effective as the predicate. The "acceptance criteria" in this context are implicitly that the geko™ T-1's performance is either similar to or better than the predicate device, especially in its indicated uses.
Table of "Acceptance Criteria" (Inferred from Substantial Equivalence Comparison) and Reported Device Performance:
| Parameter / Aspect of Performance | "Acceptance Criteria" (Inferred from Predicate Equivalence, or desired outcome) | Reported geko™ T-1 Performance |
|---|---|---|
| Intended Use | Subset of predicate's uses: Increasing local blood circulation, preventing venous thrombosis. | Meets this subset of indications. |
| Clinical Application | Prescription use in clinical/home setting, safe for single patient use. | Prescription use in clinical/home setting, single patient use for up to 30 hours (replacement recommended after 24 hours). |
| Electrical Safety | Compliance with IEC 60601-1, IEC 60601-2-10, IEC 60601-1-2. Patient leakage current within acceptable limits. | Complies with IEC 60601-1, IEC 60601-2-10, IEC 60601-1-2. Patient leakage current: |
§ 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).