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The Laser Sys*Stim 540, Model ME 540 is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm, the temporary increase in local blood circulation and/or promoting relaxation of muscles.

The Laser Sys*Stim 540, Model ME 540, is a portable, AC and battery operated non-invasive, low level infrared lamp that provides continuous and pulsed heat therapy at a fixed frequency. The system consists of a drive unit/power supply that houses the electronics, controls and displays and optional treatment probes that contain the visible and infrared radiating elements.

The provided text does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) summary statement for the Laser Sys*Stim 540, Model ME 540, and primarily focuses on its substantial equivalence to predicate devices. It describes the device, its intended use, and a comparison with predicate devices, but lacks details about specific performance metrics, clinical trials, or validation studies.

The "Testing" section only states: "Production and quality control performance and safety testing shall be performed on each system pursuant to compliance with all applicable safety standards and regulations for low level laser therapy systems." This indicates planned testing for compliance with general standards but does not provide specific acceptance criteria or the results of a study.

Therefore, I cannot provide the requested table or information as the input text does not contain the necessary details.

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