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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:

Study Details:

1. Sample size used for the test set and the data provenance:

   • Tucker et al.: Not explicitly stated, described as "subjects." (This study was foundational, not directly for geko™ T-1 validation).
   • Warwick et al.: 10 healthy volunteers.
   • Jawad et al.: 10 healthy volunteers.
   • Unpublished THR study: 40 patients undergoing elective unilateral total hip replacement.

   Data Provenance:

   • All studies appear to be prospective clinical investigations.
   • The "Unpublished study conducted at the Harbour Hospital in Poole, Dorset, UK" indicates United Kingdom as the country of origin for that specific clinical data. The provenance of the Tucker, Warwick, and Jawad studies is not explicitly stated, but their citation format (Journal/authors) might lead back to UK-based research groups given the device manufacturer's location.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   This information is not applicable in the context of this device and studies. These are physiological measurements (blood flow velocity, volume, etc.) and patient perception, not interpretations requiring expert consensus for "ground truth" like in imaging diagnostics. The measurements themselves are the "ground truth" for the physiological effect.

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

   This information is not applicable. The studies involve objective physiological measurements (e.g., Doppler ultrasound) and subjective patient ratings (e.g., verbal rating scale, VAS), not an adjudication process of expert interpretations.

4. 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 applicable. This device is a neuromuscular stimulator, not an AI-powered diagnostic imaging tool. It does not involve "human readers" or "AI assistance" in the sense of image interpretation. The performance is the device's direct physiological effect.

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

   This information is not applicable. The geko™ T-1 is a powered muscle stimulator, a physical device, and not an algorithm or AI. Its performance is always "standalone" in the sense that it directly stimulates the muscle as intended, but it's used by a human (the patient or caregiver) who applies it and adjusts settings for comfort. The studies evaluate the device's effect without needing human interpretative input in the measurement process.

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

   The "ground truth" in these studies is primarily:

   • Objective physiological measurements: Venous blood flow velocity, blood volume, microcirculatory flux/velocity (measured via Doppler ultrasound, ultrasound imaging).
   • Subjective patient perception: Discomfort ratings (verbal rating scale, visual analog scale).
   • Clinical outcomes (implied): For the THR study, the primary outcome measured was DVT prophylaxis efficacy parameters (blood flow increase), rather than direct DVT incidence, demonstrating the physiological mechanism to achieve the stated indication.

7. The sample size for the training set:

   This information is not applicable. The geko™ T-1 is a physical medical device, not a machine learning model that requires a "training set." The design and engineering of the device are based on scientific principles and previous research (like the initial Tucker et al. study) but not a "training set" in the AI sense.

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

   This information is not applicable as there is no "training set" for a physical medical device.

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