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

The geko™ T-3 Neuromuscular Stimulator (geko™ T-3) is 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 geko™ T-3 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 stimulus intensity varies with the pulse width, which can be set to one of 11 levels: 35, 50, 70, 100, 140, 200 or 280 at 27 mA; 280 or 400 at 38 mA; and 400 or 560 at 54 mA. 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 and is used to isometrically stimulate the calf and foot muscles with a cadence and energy similar to that of walking.

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided FDA 510(k) summary for the geko™ T-3 Neuromuscular Stimulator:

This document is a premarket notification (510(k)) submission, which aims to demonstrate that a new medical device is substantially equivalent to a legally marketed predicate device. For devices seeking 510(k) clearance, the "acceptance criteria" are primarily established by showing that the new device has the same indications for use and similar technological characteristics to a predicate device, and that any differences do not raise new questions of safety and effectiveness.

The core "study" proving the device meets the acceptance criteria in a 510(k) context is a comparative analysis with predicate devices and verification/validation testing of the device's adherence to relevant performance and safety standards.

1. Table of Acceptance Criteria and Reported Device Performance

For the geko™ T-3 Neuromuscular Stimulator, the "acceptance criteria" are largely met by demonstrating substantial equivalence to its predicate devices (geko™ T-2 and geko™ Plus R-2). The reported device performance is shown by its adherence to technical specifications and compliance with recognized electrical safety and electromagnetic compatibility standards.

Study Description (for 510(k) Substantial Equivalence)

The "study" in this context is a series of verification and validation activities conducted by the manufacturer to demonstrate substantial equivalence to predicate devices and adherence to regulatory standards.

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

• Sample Size: Not applicable in the conventional sense of a clinical trial patient sample size. For this 510(k) submission, the "test set" consisted of the geko™ T-3 device itself and its components. The document describes verification and validation testing (e.g., electrical safety, EMC, hardware/firmware functionality). The sample size for these tests refers to the number of devices or components tested to ensure they meet specifications and standards. This typically involves testing a sufficient number of units to ensure reliability and compliance, though the exact number of units tested is not specified in this summary.
• Data Provenance: The testing was conducted as part of the company's design change procedures. The manufacturer, Firstkind Limited, is based in High Wycombe, UK. This suggests the testing data originates from the UK. The document doesn't specify if the testing was retrospective or prospective, but typically design verification and validation testing is prospective to the submission.

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

• This type of information is generally not required for a 510(k) submission that relies on technical equivalence and performance testing rather than clinical data interpretations by experts (like for imaging AI).
• The "ground truth" here is adherence to engineering specifications and international safety standards. The "experts" would be the certified testing bodies and internal quality/regulatory engineers with expertise in electrical engineering, medical device standards, and quality management systems (e.g., IEC standards, ISO 13485). Their qualifications are typically implied by their accreditation and certifications to perform such tests.

4. Adjudication Method for the Test Set:

• Not applicable as this is not a study involving human readers or interpretations of complex data like medical images. The "adjudication" is compliance with documented test procedures and objective measurements against established engineering and safety standards.

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 comparative effectiveness study was not done. This device is a neuromuscular stimulator for physical indications, not an AI imaging diagnostic tool. Therefore, MRMC studies and human reader improvement metrics are not relevant to this submission.

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

• This concept is typically relevant for AI/ML algorithms. For this device, the "standalone" performance refers to the device's ability to operate according to its specifications and comply with safety standards independent of human intervention in its function. The Hardware/Firmware Testing section mentions "Verification of output waveform characteristics via oscilloscope output tracings" and "Validation of all geko™ T-3 hardware and firmware functionality." This is essentially "standalone performance" testing for a hardware device with embedded software.

7. The type of ground truth used:

• The ground truth for the device's "performance" and "safety" is established by:
  • Engineering Specifications: The defined output parameters (current, voltage, pulse width, frequency, net charge, etc.) and physical characteristics.
  • International Standards: Compliance with recognized medical electrical equipment (IEC 60601-1, IEC 60601-2-10, IEC 60601-1-11) and electromagnetic compatibility (EN 60601-1-2) standards.
  • Comparison to Predicate Devices: The established safe and effective design and performance of the legally marketed predicate devices (geko™ T-2 and geko™ Plus R-2).

8. The sample size for the training set:

• Not applicable. This device is hardware with embedded software, not an AI/ML device that requires a "training set" of data in the common sense for model development. The software capabilities are validated through traditional software verification and validation activities (e.g., unit testing, integration testing, system testing).

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

• Not applicable for AI/ML training data. Any "ground truth" for the device's design and embedded software was established through engineering design principles, risk analysis, and adherence to performance specifications and relevant international standards.

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