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The BioFlex™ Prescription Unit and related Treatment Heads is used by trained health care professionals and is indicated for the use to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for temporary relief of minor muscle and joint pain, arthritis, muscle spasm, relieving stiffness and promoting relaxation of muscle tissue.

The BioFlex™ Prescription Unit and related Treatment Heads are designed for clinical applications to provide low level light therapy and and display system parameters as part of the treatment session. This device does NOT store patient data. As such, this device is a Class II device, having Regulation Number: 21 CFR part 890.5500. Product Code ILY.

The BioFlex™ Prescription Unit and related Treatment Heads are described as a Class II Low Level Laser treatment heads that apply energy, which penetrates the skin surface to the underlying tissues, and triggers normal cellular functions that lead to a surgery-free, drug-free, and low cost benefit to the patient, the practitioner and the health care system.

The BioFlex™ Prescription Unit and related Treatment Heads is a" multi-mode" low level light treatment system configured for multiple treatment heads and powered by a flexible protocol controller that delivers various treatment protocols.

This document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The provided text is a summary of safety and effectiveness, a 510(k) clearance letter from the FDA, and an indications for use statement for the BioFlex Prescription Unit and related Treatment Heads.

It states that the device is substantially equivalent to predicate devices, and that factory calibration tests are conducted to verify accuracy and calibration. However, it does not provide specific acceptance criteria values, performance metrics for the device, details of a study (sample size, data provenance, ground truth, etc.), or any information about AI or human reader improvement.

Therefore, I cannot fulfill your request for the table, study details, or other specific information related to acceptance criteria and a study proving device performance based on the provided text.

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