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The Compex Wireless USA is an Over-The-Counter device intended to stimulate healthy muscles in order to improve or facilitate muscle performance. It is to be used by adults only.

The Compex Wireless USA is not intended for adjunctive therapy in the treatment of medical diseases and conditions of any kind. None of the Compex Wireless USA stimulation programs are designed for injured or disease afflicted muscles. Its use on such muscles is contraindicated. The work imposed on the muscles by the Compex Wireless USA programs is definitely not suitable for rehabilitation and physiotherapy. The Compex Wireless USA electrical impulses allow the triggering of action potentials on motoneurones of motor nerves (excitations). These excitations of motoneurones are transmitted to the muscle fibers via the motor endplate where they generate mechanical muscle fiber responses that correspond to muscle work. Depending on the parameters of the electrical impulses (pulse frequency, duration of contraction, duration of rest, total session duration), different types of muscle work can be imposed on the stimulated muscles.

The Compex Wireless USA may therefore be considered a technique of muscle training.

The Compex Wireless USA is a neuromuscular electrical stimulation (NMES) device, which stimulates nerve fibers by means of electrical impulses transmitted by electrodes. The electrical pulses generated by the Compex Wireless USA stimulate motor nerves to stimulate a muscular response. Depending on the parameters of the electrical impulses (pulse frequency, duration of contraction, duration of rest, and total session duration), different types of muscle work can be imposed on the stimulated muscles. The Compex Wireless USA may therefore be considered a technique of muscle training.

The device system is made up of a remote control, 4 stimulation modules, and electrodes, which are stored and shipped within the docking station which is used to recharge the remote and the modules. The docking station is powered by an AC-DC adapter.

The remote control is the interface between the stimulation modules and the user. It sends and receives information to and from the modules via a wireless network. The remote control allows the user to navigate through the user interface (UI), select stimulation program or objectives, set desired options and control the four (4) module intensities independently. The remote control is powered by a rechargeable battery.

The Compex Wireless USA stimulation module set is composed of 4 independent stimulation modules that are controlled via the remote control by a wireless connection. Each module is composed of two "pods" (1 battery "pod" and one stimulation "pod") linked by an electrical connection (cable). Two proprietary Compex standard snap gel electrodes are also needed to connect each "pod" to the body. The modules are powered by a Lithium Polymer (LiPo) rechargeable 3.7[V] /> 450 [mAh] battery.

The wireless protocol of the Compex Wireless USA Device is a proprietary design of a Radio-Frequency protocol operating the 2.4 GHz ISM band. It is used to 1) Send particular information from remote control to stimulation modules (stimulation settings) 2) Send particular information from stimulation modules to remote control, like current stimulation level and stimulation module subsystem status, 3) Transfer binary data to stimulation modules, and 4) Allow synchronization from stimulation modules to remote control clocks.

The provided text describes the Compex Wireless USA device, its indications for use, and a comparison to a predicate device (Compex Sport Elite) for 510(k) clearance. However, it does not contain the acceptance criteria or results of a study that proves the device meets specific performance criteria in terms of accuracy, sensitivity, specificity, or other clinical efficacy metrics as would be expected for an AI/ML or diagnostic device.

The document focuses on demonstrating substantial equivalence to a predicate device through:

• Identical Indications for Use.
• Similar technological characteristics in terms of basic device attributes and output specifications.
• Performance testing related to electrical safety, electromagnetic compatibility, FCC radio frequency, software verification, usability/human factors, and wireless coexistence, all against applicable standards.

Therefore, for the information requested in your prompt, I can only provide what is available in the text, which mainly pertains to regulatory compliance and safety/performance against engineering standards, not clinical performance or artificial intelligence specific metrics.

Here's an analysis of the provided text in response to your questions:

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

The document does not present clinical acceptance criteria (e.g., accuracy, sensitivity, specificity) for a specific diagnostic task or AI performance. Instead, the "acceptance criteria" are implied by compliance with various regulatory and engineering standards, and performance testing confirming functionality and safety.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document does not describe a clinical test set or data provenance in the context of typical AI/ML or diagnostic device studies (i.e., patient data, images, etc.). The mention of "Performance Testing" refers to engineering and software validation, not clinical validation on a patient cohort.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This is not applicable as the document does not describe a clinical study involving experts establishing ground truth for a test set.

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

This is not applicable as there is no described clinical test set or adjudication process.

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

A multi-reader, multi-case (MRMC) comparative effectiveness study was not done. This device is a muscle stimulator, not a diagnostic imaging device with human readers.

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

This is not applicable in the sense of an AI algorithm making a diagnosis or prediction. The device itself is "standalone" in its operation of muscle stimulation, controlled by the user.

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

For the engineering and software validation tests performed, the "ground truth" would be the expected behavior and specifications defined by the design requirements and industry standards. For example, for "Software Verification," the ground truth is that the software performs its functions as designed. For "Electrical Safety," the ground truth is that the device passes specific tests outlined in the relevant IEC/AAMI standards. These are not clinical ground truths like pathology or outcomes data.

8. The sample size for the training set

This is not applicable. The device is not an AI/ML algorithm that requires a "training set" in the common sense of machine learning.

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

This is not applicable.

In summary: The provided FDA 510(k) clearance document for the Compex Wireless USA is for a traditional medical device (a powered muscle stimulator). It demonstrates substantial equivalence to a predicate device and compliance with safety and performance standards through engineering tests. It does not present clinical performance data, AI/ML algorithm validation, or studies involving human readers, test sets, or ground truth establishment in the context of diagnostic or AI-powered devices.

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