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EpiLight® and PhotoDerm® HR are used for the removal of unwanted hair. EpiLight® and PhotoDerm® HR are also intended to effect stable long-term, or permanent hair reduction in skin types I-V through selective targeting of melanin in hair follicles. Permanent hair reduction is defined as a long-term stable reduction in the number of hairs regrowing after a treatment regime.

EpiLight® and PhotoDerm® HR are electro-optical medical devices designed for effective photothermal treatment of unwanted hair and its removal.

The provided text is a 510(k) summary for the EpiLight® and PhotoDerm® HR devices, which are electro-optical medical devices for hair removal. The document focuses on establishing substantial equivalence to predicate devices rather than providing detailed acceptance criteria and study results for a new AI-powered device. Therefore, much of the requested information regarding AI device performance, sample sizes, ground truth establishment, and MRMC studies is not available in the provided text.

Based on the information given, here's what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly define acceptance criteria in terms of specific quantitative metrics (e.g., sensitivity, specificity, accuracy) for a new device's performance. Instead, it relies on demonstrating "substantial equivalence" to predicate devices through technical comparisons and clinical trials.

The primary performance claim for the EpiLight® and PhotoDerm® HR is:

• Permanent hair reduction: Defined as a long-term stable reduction in the number of hairs regrowing after a treatment regime.

The document states that a technical comparison and clinical trials were performed to establish substantial equivalence. However, no specific performance metrics resulting from these studies are provided in this summary.

2. Sample Size Used for the Test Set and Data Provenance

The document mentions "clinical trials were performed by ESC Medical Systems," but it does not provide any details about:

• The sample size of the test set (number of participants or observations).
• The data provenance (e.g., country of origin, retrospective or prospective nature of the data).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The document does not provide any information regarding experts used to establish ground truth.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. The devices described are medical devices for hair removal, not AI-assisted diagnostic tools requiring reader interpretation. Therefore, there is no discussion of human reader improvement with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This question is not applicable. The devices are physical medical devices for hair removal, not AI algorithms.

7. The Type of Ground Truth Used

Given the nature of the device (hair removal), the "ground truth" for "permanent hair reduction" would most likely be based on clinical observation and measurement of hair regrowth over time following a treatment regime. However, the document does not explicitly state the method for establishing this ground truth (e.g., photographic assessment, hair count, patient self-reporting, etc.).

8. The Sample Size for the Training Set

This question is not applicable as the document describes a physical medical device, not an AI algorithm that undergoes training.

9. How the Ground Truth for the Training Set Was Established

This question is not applicable.

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