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The sole indication for use of this medical device is as an epilator for the removal of undesired body hairs using the techniques described in the Owner's Instruction Brochure.

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I am sorry, I cannot fulfill your request to describe the acceptance criteria and study proving device performance based on the provided text. The document is an FDA 510(k) clearance letter for a device called "Emjoi Beauty" and focuses on regulatory approval rather than a detailed performance study. It mentions the device is an epilator for hair removal and references an "Owner's Instruction Brochure" for techniques, but it does not contain the specific information you asked for regarding:

1. A table of acceptance criteria and reported device performance.
2. Sample size and data provenance for a test set.
3. Number and qualifications of experts for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study or its effect size.
6. Standalone algorithm performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

This document is a letter confirming substantial equivalence to a predicate device, which is a regulatory standard, not a detailed scientific study report with performance metrics.

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The sole indication for use of this Class III Tweezer-Type Epilator medical device is for the removal of undesired body hairs using the techniques described in the Owner's Instruction Brochure.

Class III Tweezer-Type Epilator

This document is a 510(k) clearance letter from the FDA for a device called "Elysee Hair Removal System." It primarily grants marketing authorization and does not contain detailed information about acceptance criteria or specific study results to prove device performance.

Therefore, I cannot provide the requested information. The document focuses on regulatory approval based on substantial equivalence to a predicate device, rather than providing a performance study report.

Ask a specific question about this device