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510(k) Data Aggregation
(64 days)
The geko(TM) Plus R-2 is intended for:
- Increasing local blood circulation; and
- Immediate post-surgical stimulation of the calf muscles to prevent venous thrombosis.
The geko™ Plus R-2 Neuromuscular Stimulator (geko™ Plus R-2) is a disposable, fully integrated unit composed of a constant current pulse generator with embedded software and battery enclosed in an over-molded plastic casinq, and a silver electrode with a hydrogel coating which provides a means of attachment of the device and electrical contact with the patient. Two buttons are used to control the On/Off function and increase or decrease the intensity level of the device output, which is achieved through changes in the delivered pulse width. The geko™ Plus R-2 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.
The provided text describes a 510(k) premarket notification for the Geko™ Plus R-2 Neuromuscular Stimulator. This document focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a study to prove acceptance criteria with detailed performance metrics as would be found for an AI/ML device.
Therefore, many of the requested categories for AI/ML device studies are not applicable to this submission.
Here's a breakdown of the information that can be extracted and where the document falls short for AI/ML specific criteria:
1. A table of acceptance criteria and the reported device performance
The document does not provide specific acceptance criteria in terms of performance metrics (sensitivity, specificity, etc.) for the device's intended use (increasing local blood circulation, preventing venous thrombosis). Instead, it establishes substantial equivalence based on technical specifications and safety standards compared to a predicate device.
The table on pages 6-8 is a comparison of design parameters between the predicate device (geko™ T-2) and the proposed device (geko™ Plus R-2). It highlights technical specifications rather than clinical performance acceptance criteria.
| Parameter | Predicate geko™ T-2 (Reference for Substantial Equivalence) | Proposed geko™ Plus R-2 (Reported Device Performance) |
|---|---|---|
| Intended Use and Indications for Use | • Increasing local circulation | |
| • Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis | Same | |
| Clinical application | Prescription use only for use in a clinical or home use setting. Single patient use for up to 30 hours. Disposable. | Same |
| Anatomical Sites | Electrodes applied to the posterior aspect of the knee only for stimulation of the peroneal nerve. | Same |
| Shelf Life | 24 months | Same |
| Power source | One CR2032 primary lithium coin cell. Not replaceable by user. | Same |
| -Method of Line Current Isolation | N/A | N/A |
| -Patient Leakage Current (Normal Condition) |
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