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Neuromuscular electronic stimulator indicated for use under medical supervision for adjunctive therapy in the treatment of medical diseases and conditions.

As powered muscle stimulator:

• Temporary Relaxation of muscle spasms
• Prevention or retardation of disuse atrophy
• Increasing local blood flow in the treatment area
• Muscle re-education
• Prevention of post-surgical phlebo-thrombosis through immediate stimulation of calf muscles
• Maintaining or increasing range of motion

As external functional neuromuscular stimulator:

• Helps to relearn voluntary motor functions of the extremities
  The device must be used by trained and qualified personnel.

The g.Estim FES is a constant-current powered muscle stimulator that can deliver rectangular electrical pulses with alternating polarities, lengths and amplitudes, or trains of such pulses. The device is battery supplied and can be connected via USB to a computer. It can be triggered via software or with a hand or foot switch.

The programmable parameters of the stimulator are: frequency, current, pulse width, ramp up and down and session length. The phase width and the stimulation current can be changed during stimulation; the other parameters can only be changed when the stimulator is stopped. Stimulation can be started and stopped using a configurable ramp for smooth on- and offsets. A LED shows the stimulus onset.

The system consists of the stimulator, a USB connector cable to connect the device to a host computer, patient cables for electrode connection and a software package including the driver and a graphical user interface. Optional trigger out cables and trigger in cables as well as a hand switch and foot switch to trigger the stimulator are available. The device stops stimulation if an over-load is detected or the electrodes are disconnected.

A foot switch or hand switch can be used to trigger the stimulator.

The device can perform an impedance measurement to check the electrodes impedance before the stimulation is done and can measure the actual stimulation current when a stimulation is done. The impedance measurement is done quickly so that the stimulation can rapidly be performed. If a high impedance is detected the stimulator does not stimulate.

g.Estim FES works in the same manner as the approved predicate devices.

The provided document is a 510(k) summary for the g.Estim FES device, a neuromuscular electronic stimulator. It details various technical characteristics of the device and compares them to predicate devices to demonstrate substantial equivalence, rather than providing an independent study report with acceptance criteria and performance against those.

Therefore, many of the specific questions about acceptance criteria for an AI/ML device study, such as sample size for test/training sets, expert ground truth establishment, MRMC studies, or standalone performance, are not directly applicable or answerable from this document, as it concerns a physical medical device (electrical stimulator) which relies on demonstrating technical similarity and compliance with safety standards rather than AI performance metrics.

However, I can extract the relevant information regarding acceptance criteria (in the context of demonstrating substantial equivalence to predicate devices) and the "study" or testing that proves the device meets these "acceptance criteria" as described in this 510(k) summary.

Device: g.Estim FES (Neuromuscular Electronic Stimulator)

Regulatory Submission: 510(k) Premarket Notification (K200088)

In the context of this 510(k) submission for a non-AI medical device, "acceptance criteria" refer to the technical specifications and safety standards a new device must meet or demonstrate substantial equivalence to, compared to legally marketed predicate devices. The "study" involves technical testing and comparison against these predicate devices.

Here's the information extracted and re-framed to address your request, acknowledging the nature of the device and its regulatory pathway:

1. A table of acceptance criteria and the reported device performance

The "acceptance criteria" for this conventional medical device are implicitly defined by the technical specifications of the predicate devices and relevant safety standards (IEC 60601 series). The "reported device performance" is the g.Estim FES's measured technical characteristics. The document presents a comparative table (starting on page 6 and continuing through page 14) that serves this purpose.

Below is a summarized version of key performance characteristics and their comparison, focusing on how the g.Estim FES meets the "acceptance criteria" by demonstrating equivalence or adherence to standards.

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