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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-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 usec to 400 usec) and one of eight levels for the geko™ Plus R-2 (ranging from 50 usec to 560 usec). The constant current output at each pulse width setting is nominally 27 mA for the geko™ T-2 and 54 mA for the geko™ Pus 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 document is a 510(k) summary for the geko™ T-2 and geko™ Plus R-2 Neuromuscular Stimulators, seeking to add an indication for use: "Edema reduction". This document does not describe an AI/ML device, nor does it provide the kind of detailed performance study typically associated with AI/ML device clearances (e.g., acceptance criteria tables, MRMC studies, ground truth establishment methods for large datasets).

Instead, it's a premarket notification for a traditional medical device, demonstrating substantial equivalence to a predicate device for a new indication. The "performance data" section describes a small clinical study, not an AI/ML performance evaluation.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance (in the context of AI/ML).
2. Sample size for a test set (as in AI/ML evaluation).
3. Number of experts and their qualifications for ground truth establishment.
4. Adjudication method.
5. MRMC study details or effect size.
6. Standalone performance for an algorithm.
7. Type of ground truth used (in the context of AI/ML).
8. Sample size for a training set.
9. How ground truth was established for a training set.

The document only provides information relevant to the clinical study conducted for the device's effectiveness in edema reduction, not an AI/ML model's performance.

Here's what the document does state regarding the clinical study (analogous to 'performance data' for this type of device):

Clinical Study Details (from Section H. Discussion of Performance Data):

• Study Type: Clinical trial (randomized).
• Purpose: To demonstrate the safety and effectiveness of the geko devices in the reduction of edema.
• Sample Size:
  • 26 subjects undergoing total hip replacement surgery.
  • geko™ device group: n=14
  • Compression stockings group: n=12 (control/comparator)
• Intervention: Randomized therapy (geko™ device or compression stockings) applied bilaterally immediately following surgery and worn continuously until hospital discharge (except for bathing/procedures). Geko™ devices changed every 24 hours.
• Measurements: Circumference measurements of operated and non-operated legs (ankle, calf, thigh) immediately prior to and following surgery, and daily until hospital discharge.
• Outcome Measure: Total leg volume determined using a conical model from circumference measurements.
• Results:
  • "Less edema formation for the subjects treated with the geko™ devices as compared to compression stockings in both the operated and non-operated legs."
  • Statistical significance reached by Day 1 post-op and continued until hospital discharge.
• Adverse Events: "No device-related adverse events or serious adverse events were reported for either the geko™ devices or compression stockings."
• Conclusion (of the study): The clinical data supports the safety and effectiveness of the geko™ devices for edema reduction.

Ground Truth (in the context of this clinical study): The 'ground truth' here would be the actual measured changes in leg circumference/volume and clinical observation of adverse events, assessed by medical staff in a hospital setting. It's not a consensus reading by experts on images, but rather direct physiological measurement and adverse event reporting.

This document is a declaration of substantial equivalence for a physical medical device, not a regulatory submission for an AI/ML diagnostic or therapeutic algorithm. Therefore, the questions related to AI/ML specific evaluation criteria are not applicable.

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