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The Polaris WR is indicated for non invasive wrinkles treatment.

The Polaris WR is a device that is used for non invasive wrinkles treatment. The Polaris WR treatment is based on the principle of selective (electromagnetic) thermolysis. According to this principle, parameters of optical and RF cnergy (spectrum, exposure duration and energy density) are chosen and optimized to selectively damage to the treatment target without damaging the surrounding tissues.

The provided text is a 510(k) summary for the Polaris WR device, which is indicated for non-invasive wrinkle treatment. It focuses on establishing substantial equivalence to predicate devices and does NOT contain information about specific acceptance criteria, performance studies, or clinical trial data with expert ground truth, sample sizes, or MRMC studies.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes for test sets or data provenance.
3. Number and qualifications of experts for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study results.
6. Standalone performance results.
7. Type of ground truth used.
8. Sample size for the training set.
9. How training set ground truth was established.

This document is a regulatory submission for premarket notification (510(k)) and is not a clinical study report. It states that "Based upon an analysis of the overall performance characteristic for the device, Syneron Medical Ltd. believes that no significant differences present. Therefore the Polaris WR should raise no new issues of safety or effectiveness." This statement is the basis for their claim of substantial equivalence to predicate devices, rather than a detailed account of new performance data or clinical trials specific to the Polaris WR.

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