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BionicGym is intended to stimulate healthy muscles in order to exercise, improve or facilitate muscle performance. It is not intended to be used in conjunction with therapy or treatment of medical conditions of any kind. None of the training programs or operational parameters are designed to target injured or ailing muscles.

The BionicGym Powered Muscle Stimulator is a home use, wearable device in the form of a double thigh wrap garment. The electronics are housed in a control unit that is fitted into a pocket on the right thigh garment. The control unit generates electrical pulses which are distributed to hydrogel electrodes positioned within the thigh garments and in contact with the user's thighs. The control unit delivers pulses to the muscles via the electrodes in defined patterns, which cause controlled contractions of the legs. The program characteristics determine the leg muscle contractions, which may be tetanic or sub-tetanic, the latter of which can induce cardiovascular and aerobic demand, thus the user receives an exercise workout. The intensity of the workout can be selected from a suite available via a smart device (e.g. phone) based application ('App'). The workout can be paused or stopped from either the App or the control unit.

The principle of operation of the BionicGym Powered Muscle Stimulator is that the pulse pattern delivered to the thigh electrodes is a composite of pulses shared between the electrode array. Repeating the pulse pattern induces contractions of the large muscle groups in the legs (quadriceps, hamstrings, gluteal and calf muscles), exercising the legs and raising the user's heart rate.

The provided document is a 510(k) summary for the BionicGym Powered Muscle Stimulator. It outlines the device's technical specifications and compares it to a predicate device, focusing on non-clinical performance testing. However, it does not include data from a clinical study with acceptance criteria and reported device performance. The information is limited to non-clinical testing performed to demonstrate substantial equivalence to a predicate device.

Therefore, I cannot provide a table of acceptance criteria and reported device performance based on a clinical study from this document, nor can I answer questions related to sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, multi-reader multi-case studies, standalone performance, type of ground truth used from a clinical study, or training set details. This information would typically be found in a clinical study report, which is not part of this 510(k) summary.

The document focuses on non-clinical testing to demonstrate that the device meets safety and performance standards comparable to an existing device, rather than proving effectiveness against specific clinical acceptance criteria.

Here's what can be extracted regarding the device's testing and a comparison to its predicate:

1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical):

The document details compliance with various international standards for electrical safety, electromagnetic compatibility, and biocompatibility, as well as software verification and validation. These standards serve as the "acceptance criteria" for non-clinical performance. The "reported device performance" is a statement of compliance.

Regarding the other points, the document states:

2. Sample size used for the test set and the data provenance: Not applicable. This document describes non-clinical performance testing and comparison to a predicate device, not a clinical study with a test set of patients.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth and expert consensus are typically associated with clinical validations of diagnostic or prognostic devices. This device is a muscle stimulator.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

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 a muscle stimulator, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The device is a physical muscle stimulator, with software controlling its function. Its "performance" is its ability to stimulate muscles according to its programmed parameters, which is assessed through bench testing and compliance with standards.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the traditional sense for a diagnostic device. For the non-clinical tests, the "ground truth" is defined by the objective pass/fail criteria of the international standards (e.g., specific current leakage limits, biocompatibility results) and engineering specifications for bench tests.

8. The sample size for the training set: Not applicable. This document does not describe a machine learning algorithm or a training set. The software mentioned is traditional control software.

9. How the ground truth for the training set was established: Not applicable.

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