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1. Indications for Medium Frequency (Russian), Biphasic, High Volt Pulsed Current (HVPC), Interferential (4P) and Premodulated (2P) waveforms

• Relaxation of muscle spasms
• Prevention or retardation of disuse atrophy
• Increase local blood circulation
• Muscle re-education
• Maintaining or increasing range of motion
• Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis

2. Additional indications for Microcurrent, Interferential (4P), Premodulated (2P), Biphasic and TENS waveforms

• Symptomatic relief and management of chronic, intractable pain
• Post-traumatic acute pain
• Post-surgical acute pain

3. Indications for DC (Direct Current) Mode

• Relaxation of muscle spasm

4. The laser and cluster applicators of the Sys*Stim 240 emit infrared energy for:

• Temporary increase in local blood circulation
• Temporary relief of minor muscle and joint aches, pains and stiffness
• Relaxation of muscles
• Temporary relief of muscle spasms
• Temporary relief of minor pain and stiffness associated with arthritis

The new Sys*Stim® 240 neuromuscular stimulator features nine discrete waveforms designed to facilitate clinical versatility. Waveforms may be combined with on-off programs for neuromuscular education as well as frequency and amplitude modulation programs for optimal pain management.

New touch-sensitive technology has been used to make starting a treatment easy. The high-resolution color display allows clinicians to monitor all treatment parameters continuously. The patented M Wheel™ provides easy navigation through all of the menus.

Clinicians can add full-featured light therapy capabilities to the SysStim 240 by purchasing either the cluster or laser applicator package. The laser applicator has an 80 mW, 785 nm, laser diode and the cluster emits 500 mW at 600 and 950 nm. Applicator holders are provided with each applicator and can be attached to the sides of the SysStim 240.

Treatment protocols complete with electrode placement quidance allow clinicians to quickly program treatment parameters for their patients. There is even space to save special treatment protocols for each waveform and for light therapy.

The Sys*Stim 240 has an optional battery pack so that clinicians can take either electrical stimulation or light therapy to their patients. A carrying case is also available which holds the units and all the accessories necessary for therapy on the road.

The Mettler Sys*Stim 240 is a neuromuscular stimulator and low-level light therapy device. The provided text describes its features, intended uses, and lists performance testing certifications but does not contain information about a study proving specific performance acceptance criteria for diagnostic or clinical efficacy aspects that would typically require a test set, ground truth, or expert evaluation.

Instead, the acceptance criteria and supporting "study" are focused on compliance with established electrical safety, electromagnetic compatibility (EMC), and laser safety standards, as well as showing substantial equivalence to a predicate device based on technical specifications and functional capabilities.

Here's a breakdown of the information requested, based on the provided text:

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

The acceptance criteria are primarily compliance with various electrical safety and performance standards. The "reported device performance" is the certification of compliance.

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

Not applicable. The "test" in this context refers to engineering and compliance testing of the physical device and its electrical outputs against standards, not a clinical study on a patient population. There is no test set of patient data described.

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

Not applicable. Ground truth for clinical assessment is not relevant to the compliance testing described. Certifications are typically issued by accredited testing bodies (e.g., ITS, ETL).

4. Adjudication method for the test set

Not applicable. This concept is for clinical studies, not product safety and performance standard compliance testing.

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 and light therapy device, not an AI-powered diagnostic tool. No MRMC study was conducted or mentioned.

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

Not applicable. There is no algorithm for diagnostic performance described. The "standalone performance" would be the device's adherence to its electrical output specifications and safety standards, which are evaluated through engineering tests.

7. The type of ground truth used

For the engineering and safety compliance tests, the "ground truth" would be the defined parameters and limits specified by the electrical, EMC, and laser safety standards (e.g., IEC 60601-1, IEC 60825-1, FCC regulations).

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device.

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

Not applicable.

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