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• Local anesthetic effect which significantly reduces pain . following an injury, surgery or rehabilitative therapy
• Early use of cold therapy following an injury or surgery will ● reduce primary bleeding and swelling
• Temporary decrease in blood circulation, where applied, . reduces pain and swelling.

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The provided text is a 510(k) premarket notification letter from the FDA regarding the BREG, Inc. Polar Care 500 device. This document primarily focuses on regulatory approval and does not contain the detailed technical study information required to answer your specific questions about acceptance criteria and device performance studies.

Therefore, I cannot provide the requested information, including:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set and data provenance.
3. Number of experts used to establish ground truth and their qualifications.
4. Adjudication method for the test set.
5. Information about a multi-reader multi-case (MRMC) comparative effectiveness study or its effect size.
6. Whether a standalone performance study was done.
7. The type of ground truth used.
8. The sample size for the training set.
9. How the ground truth for the training set was established.

This document confirms the device's substantial equivalence to a predicate device and lists its indications for use, but it does not detail the specific performance studies that led to this determination.

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