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The Aurora SR is intended for use in dermatology for superficial benign vascular and pigmented lesion treatment.

The Aurora SR is a device that is used for superficial benign vascular and pigmented lesion treatment. The Aurora SR treatment is based on a principle of selective thermolysis. According to this principle, parameters of optical and RF energy (spectrum, exposure duration and energy density) are chosen (and optimized) to selectively damage (destroy) vascular and pigmented lesions without damaging the surrounding tissues.

This is a 510(k) summary for a Special 510(k) for the Syneron Medical Ltd. Aurora SR device. The provided document is a regulatory submission for a medical device and does not contain information about acceptance criteria or a study proving device performance against such criteria.

The document states that the modifications to the Aurora SR (an increase in RF energy output) "do not affect the intended use or alter the fundamental scientific technology of the device" and "raise no new issues of safety or effectiveness." This implies that the device's safety and effectiveness were considered established by the predicate device (K022266).

Therefore, I cannot fulfill your request for:

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

These details are typically found in a full efficacy study report, which is not part of this 510(k) summary. The purpose of a 510(k) Special submission is to demonstrate that a modified device is substantially equivalent to a legally marketed predicate device, often without requiring new clinical trials if the modifications do not significantly change safety or effectiveness.

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