Search Results

The Polaris LV is intended for use in dermatology for treatment of vascular lesions.
The Polaris LV is indicated for treatment of vascular lesions.

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

The provided text is a 510(k) summary for the Polaris LV device, which is indicated for the treatment of vascular lesions. This document primarily focuses on demonstrating substantial equivalence to predicate devices and does not contain information about specific acceptance criteria, device performance studies, or the methodologies used to establish ground truth or gather data.

Therefore, I cannot provide the requested information, including:

1. A table of acceptance criteria and the reported device performance: This information is not present in the document.
2. Sample size used for the test set and the data provenance: Not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
4. Adjudication method for the test set: Not mentioned.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: Not mentioned.
6. If a standalone performance (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical device, not an algorithm.
7. The type of ground truth used: Not mentioned.
8. The sample size for the training set: Not applicable, as this is a physical device, not an algorithm being trained.
9. How the ground truth for the training set was established: Not applicable.

The document states that "Based upon an analysis of the overall performance characteristic for the device, Syneron Medical Ltd. believes that no significant differences exit. Therefore the Polaris DS should raise no new issues of safety or effectiveness." This statement refers to the substantial equivalence argument based on the device's operating principle (selective thermolysis using optical and RF energy) and its intended use, rather than detailed performance study results from a clinical trial with specific acceptance criteria and outcome measures.

Ask a specific question about this device