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• Increasing local blood circulation
• Immediate post-surgical stimulation of the calf muscles to prevent venous thrombosis

The geko™ T-2 and geko™ Plus R-2 Neuromuscular Stimulator devices were previously described in K152677 and K160299, respectively. There have been no changes to the design, technical specifications, or manufacturing of these devices since previously cleared. The devices are single patient use and disposable with fully integrated electronics composed of a constant current pulse generator with embedded software and a lithium-ion battery enclosed in a 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. 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 devices are 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 stimulus intensity varies with the pulse width, which can be set to one of seven levels for the geko™ T-2 (ranging from 50 µsec to 400 µsec) and one of eight levels for the geko™ Plus R-2 (ranging from 50 µsec to 560 µsec). The constant current output at each pulse width setting is nominally 27 mA for the geko™ T-2 and 54 mA for the geko™ Plus R-2. The asymmetric biphasic waveform results in a net charge of zero to the patient during each pulse cycle. The pulse rate is fixed at a frequency of 1 Hz for both devices and is used to isometrically stimulate the leg and foot muscles with a cadence and energy similar to that of walking.

The provided text is a 510(k) summary for the Firstkind Limited geko™ T-2 and geko™ Plus R-2 Neuromuscular Stimulators. This document primarily focuses on a labeling modification (removal of a warning) and provides performance data related to electromagnetic compatibility, not the clinical efficacy or diagnostic performance typically associated with AI/ML device studies.

Therefore, many of the requested elements for an AI/ML device study, such as expert ground truth, adjudication methods, MRMC studies, standalone algorithm performance, and sample sizes for training/test sets for an AI model, are not applicable to this document.

However, I can extract the acceptance criteria and the (EMC) study details described:

Acceptance Criteria and Performance (Electromagnetic Compatibility)

1. Table of Acceptance Criteria and Reported Device Performance (EMC)

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Description: A "gel phantom that simulated the conductive properties of the human limb" was used. This is a simulated use bench test, not human data.
• Sample Size: Not explicitly quantified in terms of number of "samples" but described as various distances (from 500mm down to 5mm), different speeds, low and high power levels, and different cutting/coagulation modes of the HF electrosurgery device. This indicates a factorial design covering different operational conditions.
• Data Provenance: This is a bench test (simulated), not from a specific country or patient cohort, and is by nature prospective as it's a controlled experiment designed for this purpose.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

• Not Applicable. This is a bench test assessing physical performance (electrical parameters, absence of burns on a phantom). Expert "ground truth" in the sense of clinical interpretation or diagnosis is not relevant here. The "ground truth" is the physical measurement of device output and observation of the phantom for burns.

4. Adjudication Method for the Test Set

• Not Applicable. As this is a bench test with objective measurements and observations, there is no need for adjudication by multiple human observers.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No. This type of study is relevant for evaluating the impact of AI on human diagnostic accuracy. The study described is a bench test for electromagnetic compatibility, not a clinical diagnostic study.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Not Applicable. The geko™ is a neuromuscular stimulator, not an AI algorithm. Its performance is assessed directly, not via an AI model.

7. The Type of Ground Truth Used

• Experimental Measurement/Observation: The ground truth was established by direct measurement of the geko™ device's output parameters remaining within tolerance and visual/physical confirmation of the absence of burns on the gel phantom under various high-frequency electrosurgery interference conditions.

8. The Sample Size for the Training Set

• Not Applicable. The geko™ device is not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

• Not Applicable. As there is no training set mentioned (because it's not an AI/ML device), this question is irrelevant.

In summary, the provided document details a 510(k) submission for a neuromuscular stimulator. The "performance data" highlighted refers to the device's electromagnetic compatibility (EMC) when exposed to high-frequency surgical equipment, not to the clinical or diagnostic performance of an AI/ML system. Therefore, most questions related to AI/ML study methodologies (ground truth establishment by experts, training/test sets for algorithms, MRMC studies) are not pertinent to this submission.

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