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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.

AI/ML Overview

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)	< 20μΑ	Same
-Patient Leakage Current (Single Fault Condition)	< 20μΑ	Same
Output modes	Single mode with 7 discrete stimulation settings (pulse widths)	Single mode with 8 discrete stimulation settings (pulse widths)
Output channels	Single channel	Same
-Synchronous or alternating	N/A (single channel)	Same
-Method of channel isolation	Capacitor	Same
Regulated current or regulated voltage	Current regulated	Same
Microprocessor controlled?	Yes	Same
Automatic overload trip	Yes	Same
Automatic no-load trip	Yes	Same
Automatic shut-off	Yes	Same
Patient over-ride control	Yes	Same
Indicator display (On/Off status)	Yes	Same
Indicator display (Low battery)	Yes (automatic off)	Same
Indicator display (Voltage / current level)	N/A (fixed constant current)	Same
Indicator display (Charge level (pulse width))	Yes, number of LED flashes indicate stimulation level	Same
Timer range in minutes	1800 minutes maximum (device disabled after 30 hours battery run time)	Same
Compliance with voluntary standards	IEC 60601-1:2005, IEC 60601-2-10:2012, EN 60601-1-2:2007, ISO 10993-1	Same
Compliance with 21 CFR 898	N/A (electrodes are integral with the device, no separate leads)	Same
Weight	10 g	Same
Dimensions	7.8" x 1.2" x 0.4"	Same
Housing material and construction	Plastic injection molding	Same
Waveform	Biphasic (asymmetrical biphasic with zero net DC) Rectangular, with charge balancing second phase	Same
Maximum output voltage	13.5 V @ 500 Ω 54 V @ 2000 Ω 255 V @ 10,000 Ω	27 V @ 500 Ω 108 V @ 2000 Ω 255 V @ 10,000 Ω
Maximum output current	27 mA @ 500 Ω 27 mA @ 2000 Ω 25.5 mA @ 10,000 Ω	54 mA @ 500 Ω 54 mA @ 2000 Ω 25.5 mA @ 10,000 Ω
Pulse width	50, 70, 100, 140, 200, 280, 400 μs	50, 70, 100, 140, 200, 280, 400, 560 μs
Frequency	1 Hz	Same
For interferential modes only: -beat Frequency (Hz)	N/A	Same
Multiphasic waveforms -Symmetrical phases	No	Same
-Phase duration	50-400 µs for positive phase, second (negative) phase is an exponential decay with a 0.1 s time constant	50-560 µs for positive phase, second (negative) phase is an exponential decay with a 0.1 s time constant
Net charge	0 µC at 500 Ω	Same
-How achieved	Capacitor coupling	Same
Maximum phase charge*	10.8 µC at 500 Ω	30.2 µC at 500 Ω
Maximum current density*	5.5 mA/cm²	11.0 mA/cm²
Average (r.m.s.) current density*	0.11 mA/cm²	0.26 mA/cm²
Maximum power density (averaged over the duty cycle)*	0.000000012 W/cm²	0.000000093 W/cm²
Burst mode (a,b,c,d)	N/A (single pulse, no pulse train or burst)	Same
ON Time (seconds) OFF Time (seconds)	N/A Stimulation is delivered at 1 Hz, with single pulses of 50μs to 400μs	N/A Stimulation is delivered at 1 Hz, with single pulses of 50μs to 560μs
Electrodes	Hydrogel applied to silver electrode. Biocompatibility for the hydrogel has been established.	Same
Cables/ connectors	Integrated device: no separate cables	Same
Patient-contact	Contact is made through integrated self-adhesive electrodes.	Same

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The submission relies on design validation activities (electrical safety, EMC, hardware/firmware testing) rather than a clinical study with a "test set" in the context of AI/ML.

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)

This information is not provided and is not applicable, as no clinical "test set" and ground truth establishment by experts for AI/ML performance are described. The focus is on device specifications and adherence to standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided and is not applicable, as no clinical "test set" with expert adjudication is 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

This information is not provided and is not applicable. The device is a neuromuscular stimulator, not an AI diagnostic or assistance tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This information is not provided and is not applicable. The device is a physical stimulator.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

This information is not provided and is not applicable. The assessment is based on physical device specifications and compliance with safety standards, not on "ground truth" for clinical outcomes as validated in AI studies. The "conclusion" on page 9 states that the device "performs as designed and intended," which is validated through engineering tests.

8. The sample size for the training set

This information is not provided and is not applicable, as this is not an AI/ML device requiring a training set.

9. How the ground truth for the training set was established

This information is not provided and is not applicable, as this is not an AI/ML device requiring a training set and its ground truth.

Summary of Device Performance and Substantial Equivalence:

The Geko™ Plus R-2 Neuromuscular Stimulator demonstrates substantial equivalence to its predicate device, the Geko™ T-2, primarily through a comparison of technical specifications and an affirmation that its design has been validated against relevant safety and performance standards.

Key Differences and Their Justification: The main change is the option for stronger stimulation, achieved by higher constant current (54 mA vs 27 mA) and a higher maximum pulse width setting (560 µs vs 400 µs). This change is justified by stating that the higher current and pulse width settings do not raise new safety or effectiveness concerns. The maximum voltage remains the same, and the maximum current density and power density remain well below established limits by IEC 60601-2-10:2012 and FDA guidance, respectively. The longer pulse width for the new device is also comparable to a previous predicate (geko™ T-1).
Design Validation Activities:
- Electrical Safety and Electromagnetic Compatibility Testing: The device was certified to comply with IEC 60601-1:2005 (General Safety), IEC 60601-2-10:2012 (Nerve and Muscle Stimulators), and IEC 60601-1-2:2007 (EMC).
- Hardware/Firmware Testing: Verification of output waveform characteristics (via oscilloscope tracings at different impedance levels) and validation of all hardware and firmware functionality were performed.
- Results: All test results demonstrated that the geko™ Plus R-2 meets the predefined device technical and functional requirements specifications.

In essence, the study presented here is a set of engineering verification and validation tests to ensure the device meets its design specifications and complies with regulatory safety standards, supporting the claim of substantial equivalence to its predicate. It is not a clinical study designed to measure diagnostic performance or AI effectiveness.

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