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The OmniLight VL-3000, PL-3000, DL-3000 and WL-3000 are indicated for emitting 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 pains, minor arthritis pain and muscle spasm; relieving stiffness; promoting relaxation of muscle tissue and to temporarily increase local blood circulation.

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The provided document is a 510(k) clearance letter from the FDA for the OmniLight VL-3000, PL-3000, DL-3000, and WL-3000 devices. It states that these devices are substantially equivalent to legally marketed predicate devices.

However, this letter does not contain the detailed information required to describe the acceptance criteria and a study proving the device meets those criteria. Specifically, it lacks:

• A table of acceptance criteria and reported device performance: The letter only indicates the device's intended use (topical heating for pain relief) and its classification as an infrared lamp. It does not provide any specific quantitative performance metrics or acceptance thresholds.
• Sample size and data provenance for a test set: No information regarding a test set, its size, or its origin (e.g., country, retrospective/prospective) is present.
• Number and qualifications of experts for ground truth: There's no mention of expert involvement in establishing ground truth.
• Adjudication method: Not applicable as no ground truth establishment is described.
• MRMC comparative effectiveness study results: This is not a study focused on human reader performance with or without AI, but rather a clearance for a physical therapy device.
• Standalone algorithm performance: This is not an AI algorithm, but a physical therapy device.
• Type of ground truth used: No ground truth data is discussed.
• Training set sample size: Not applicable as it's not an AI/machine learning device.
• Ground truth establishment for the training set: Not applicable.

The letter's purpose is to grant market clearance based on substantial equivalence to existing devices, not to detail the performance study results. To answer your questions, one would need access to the 510(k) submission itself, or related performance studies that would have been part of establishing substantial equivalence for the predicate device, or for the OmniLight device if specific performance claims were being made beyond those of the predicate.

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