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The Polaris DS / Comet is indicated for hair removal, permanent hair reduction. The Polaris DS / Comet is intended for use on all skin types, (Fitzpatrick skin type I-VI), including tanned skin.

The Polaris DS / Comet is a device indicated for hair removal, permanent hair reduction. The Polaris DS is intended for use on all skin types, (Fitzpatrick skin type I-VI), including tanned skin. The Polaris DS / Comet 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 to the hair follicle without damaging the surrounding tissues.

This 510(k) summary for K041959 regarding the Polaris DS / Comet device is very brief and primarily focuses on establishing substantial equivalence to predicate devices for its intended use of hair removal and permanent hair reduction across all skin types. It does not contain the detailed information required to answer most of the questions about acceptance criteria and a specific study proving device performance.

Based only on the provided text, here's what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance

The provided 510(k) summary does not contain any explicit acceptance criteria or reported device performance metrics from a clinical study. 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 DS / Comet should raise no new issues of safety or effectiveness." This statement is a general declaration of equivalence rather than a report of specific performance against defined acceptance criteria.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not describe any specific test set or clinical study, and therefore no sample size, data provenance, or study design (retrospective/prospective) is mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

No test set or ground truth establishment is described in the provided text. Therefore, this information is not available.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

No test set requiring adjudication is described in the provided text. Therefore, this information is not available.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

The device is a medical laser system for hair removal, not an AI or imaging diagnostic device that would involve "human readers" or AI assistance in the way a MRMC study typically applies. Therefore, this type of study is not applicable to this device. The provided text also makes no mention of any AI component.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This question is also more relevant to AI/diagnostic algorithms. The Polaris DS / Comet is a therapeutic device. Therefore, a "standalone algorithm performance" study is not applicable in the context of this device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Since no specific study or test set is described, the type of ground truth used is not mentioned.

8. The sample size for the training set

The document does not describe any training set, as it doesn't detail a machine learning or AI-based component of the device.

9. How the ground truth for the training set was established

As no training set is mentioned, information on how its ground truth was established is not available.

Summary of what is present:

• Device Name: Polaris DS / Comet
• Intended Use: Hair removal, permanent hair reduction on all skin types (Fitzpatrick I-VI), including tanned skin.
• Predicate Devices: Polaris DS (K024064), Polaris WR (K031671), LightSheer (K003614), Mythos 500 (K030805).
• Mechanism: Selective (electromagnetic) thermolysis using optical and RF energy to damage hair follicles without harming surrounding tissues.
• Conclusion of 510(k) Summary: Substantially equivalent to predicate devices, raising no new issues of safety or effectiveness.

Conclusion: The provided 510(k) summary is extremely high-level and serves the purpose of establishing substantial equivalence without detailing specific clinical study results, performance metrics, or method validation. For a device like a laser for hair removal, especially one cleared through the 510(k) pathway, detailed efficacy and safety data from clinical trials with specific acceptance criteria might be found in other sections of the 510(k) submission not included in this "Summary of Safety and Effectiveness."

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