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Epilaser Pro is an over-the-counter device intended for adjunctive use with shaving for hair removal sustained with periodic treatments. Epilaser is also intended for permanent reduction in hair regrowth (defined as a long-term, stable reduction in the number of hairs regrowing) when measured out to 6, 9, and 12 months after the completion of the treatment regimen.

The Epilaser Pro is an over-the-counter, hand-held, hair removal device. It kills the root of the hair follicle using laser energy at 808 or 980nm. The system includes an algorithm that automatically targets individual hairs over the treatment area and the laser activates when it is pressed against the skin. A skin tone sensor ensures the correct skin tone prior to laser activation.

The Epilaser Pro is an over-the-counter device intended for hair removal and permanent reduction in hair regrowth. This device utilizes an algorithm to automatically target individual hairs over the treatment area. The following outlines the acceptance criteria and study details.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Test Set Sample Size: 69 subjects for the efficacy study.
• Data Provenance: Not explicitly stated, but the submission is from "Epilady 2000 LLC" located in "Hazor Haglilit, Israel." Assuming the studies were conducted locally or within the submitting company's capabilities, it is reasonable to infer the data provenance is likely related to Israel. The study type is prospective, as it involved direct treatment and assessment of subjects.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Number of Experts: One dermatologist.
• Qualifications of Experts: A dermatologist was used to identify the location of hairs and pigments, and to assess skin tone. Specific years of experience are not provided, but being a dermatologist implies a high level of qualification in skin and hair assessment.

4. Adjudication method for the test set

• Adjudication Method: Not explicitly stated that an adjudication method was used between multiple experts. The ground truth was established by a single dermatologist. The device performance was compared against this single expert's "Ground Truth."

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

• A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly conducted in the traditional sense of evaluating human readers' diagnostic performance with and without AI assistance. The study compared the performance of the device (Epilaser Pro with its automatic hair targeting algorithm) to the predicate device and to a dermatologist's "Ground Truth." It did not assess human reader improvement.

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

• Yes, a standalone study was done. The efficacy study evaluated the "Epilaser Pro" (which includes the automatic hair targeting algorithm) and compared its performance (True Hits, False Hits, Not Safe Hits) against a dermatologist's "Ground Truth" and the predicate device. This assessment of the device's ability to detect and target hairs independently aligns with a standalone performance evaluation of the algorithm embedded within the device.

7. The type of ground truth used

• Type of Ground Truth: Expert consensus (from a single dermatologist) and objective assessment. The dermatologist used a dermatoscope to objectively determine the location and number of hairs, pigmented spots, tattoos, and skin tone. This forms the "Ground Truth" for comparison.

8. The sample size for the training set

• The document does not provide information regarding the sample size for the training set of the algorithm.

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

• The document does not provide information regarding how the ground truth for the training set was established. The focus of the provided text is on the validation/test set.

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