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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.

2. Sample size used for the test set and the data provenance

For this type of device (a physical electrical stimulator), there isn't a "test set" in the sense of a dataset of patient images or readings. Instead, testing involves bench testing to verify the device's technical specifications and safety features.

• Sample Size for Test Set: Not specified in terms of patient data. The "test set" implies the physical device itself and its components undergoing engineering and safety verification. Typically, a specified number of manufactured units would be tested (e.g., N=1 or N=a small batch for verification of manufacturing consistency and performance). The document states, "The stimulator was tested with a data acquisition device and provides rectangular stimulation pulses with the necessary frequency and amplitude range." This implies at least one device was tested.
• Data Provenance: Not applicable for patient data. The provenance for the device is g.tec medical engineering GmbH, located in Austria. The testing itself is a part of the submission to the FDA for market clearance in the US, indicating the testing was sufficient for US regulatory purposes. The testing is in a pre-market setting (for 510(k) clearance), meaning it's a prospective test in the sense that it's designed to verify compliance before market entry.

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

Not applicable for this type of device. "Ground truth" for an electrical stimulator does not involve expert medical readers establishing clinical reality, but rather objective measurements against engineering specifications and relevant safety standards.

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

Not applicable, as this is not a study requiring reader adjudication of medical cases. The "adjudication" is implicitly through engineering verification and validation (V&V) processes against defined technical specifications and international standards (e.g., IEC 60601 series, ISO 14971, etc.).

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

Not applicable. This device is an electrical stimulator, not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies and AI assistance comparisons are irrelevant to its regulatory clearance.

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

Not applicable. This is a physical medical device. "Standalone performance" would refer to its technical operation according to specifications, which is what the "Accepted Criteria" table and the "Testing" section (807.92(b)(1)) describe. The device functions independently as an electrical stimulator, but its medical application requires trained and qualified personnel ("human-in-the-loop").

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

The "ground truth" for this device is based on engineering specifications, direct objective measurements (e.g., voltage, current, pulse characteristics, impedance), and compliance with recognized international safety and performance standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10, ISO 14971, IEC 62304, IEC 62366). The comparison to predicate devices also establishes a de-facto "ground truth" for acceptable performance characteristics based on previously cleared devices.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires training data.

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

Not applicable. This is not an AI/ML device that requires training data and ground truth establishment in that context.

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