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The Aurora DS is indicated for the removal of unwanted hair from skin types I-VI, and to effect stable long-term, or permanent, hair reduction.

The Aurora DS is a device indicated for the removal of unwanted hair from skin types I-VI, and to effect stable longterm, or permanent, hair reduction. The Aurora DS 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 does not contain the detailed information necessary to complete all sections of your request, particularly regarding specific acceptance criteria values, sample sizes, and expert qualifications for performance studies.

This is common for older 510(k) submissions, which often presented less granular data than more recent ones require. Instead, it focuses on demonstrating substantial equivalence to predicate devices.

However, I will extract and infer information where possible based on the provided text.

Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria for hair removal or reduction beyond indicating the device should "effect stable long-term, or permanent, hair reduction." It relies on substantial equivalence to predicate devices, implying that its performance is expected to be comparable.

Study Details

Given the context of a 510(k) submission primarily focused on substantial equivalence to predicate devices, detailed clinical study methodologies are not provided in this summary. The summary highlights that "Based upon an analysis of the overall performance characteristic for the device, Syneron Medical Ltd. believes that no significant differences present." This general statement suggests that any studies conducted were likely aimed at demonstrating this equivalence rather than establishing de novo performance metrics against specific criteria.

1. Sample Size used for the test set and the data provenance:
   • Sample Size: Not specified in the provided summary.
   • Data Provenance: Not specified (e.g., country of origin, retrospective/prospective).
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   • Not specified.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
   • Not specified.
4. 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:
   • Not applicable. This device is a hair removal system, not an AI-assisted diagnostic tool.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
   • Not applicable as this is a device for hair removal, not an algorithm. Performance is inherent to the device's design and mechanism.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
   • Not explicitly stated. For hair removal devices, ground truth for efficacy would typically involve quantitative hair counts or subjective photographic assessments by clinicians and/or patients over time.
7. The sample size for the training set:
   • Not applicable, as this is a medical device for hair removal, not an AI/machine learning algorithm with a training set.
8. How the ground truth for the training set was established:
   • Not applicable.

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