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The ICL IR Heat Lamp Systems are 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 muscle.

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This document is a 510(k) premarket notification summary for an infrared lamp system. It establishes substantial equivalence to predicate devices but does not contain information about acceptance criteria or specific studies demonstrating device performance against such criteria.

Therefore, I cannot fulfill your request for the tables and details regarding acceptance criteria and study data based on the provided text. The document focuses on regulatory approval based on equivalence, not on presenting performance data from studies.

The provided text does not contain:

• A table of acceptance criteria and reported device performance.
• Sample sizes used for test sets or their data provenance.
• Number of experts used to establish ground truth or their qualifications.
• Adjudication methods.
• Information about MRMC comparative effectiveness studies or effect sizes.
• Information about standalone algorithm performance studies.
• Details on the type of ground truth used.
• Sample sizes for training sets.
• How ground truth for training sets was established.

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