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Epilaser 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 hair counts following a treatment regime. Permanent hair reduction is defined as 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 is an over-the-counter, hand-held, hair removal device intended for hair removal on the face below the nose, underarms, and bikini line. It kills the root of the hair follicle using focused laser energy. The system has an integrated microscope and external viewing screen which allows the user to visualize and target individual hairs. The system is composed of a hand held laser containing multiple safety features and a dedicated viewing screen.

The provided text is a Food and Drug Administration (FDA) 510(k) summary for the "Epilaser" device. It outlines the device's intended use, technological characteristics, and performance data to establish substantial equivalence to a predicate device.

However, the document does not contain specific acceptance criteria for device performance (e.g., efficacy in hair reduction rates) nor the results of a study that directly proves the device meets such criteria. Instead, it focuses on demonstrating safety, usability, and technical equivalence to a predicate device.

Therefore, many of the requested items (e.g., a table of acceptance criteria with reported performance, sample sizes for test/training sets with ground truth details, MRMC study results, standalone performance) cannot be extracted from this document as the information is not present.

Here's an attempt to answer the questions based only on the provided text, indicating where information is missing:

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

The document does not provide a table with specific performance acceptance criteria (e.g., a minimum percentage of hair reduction) or corresponding measured performance values for the Epilaser. The "Performance Data" section lists various tests conducted (biocompatibility, software, safety, usability, laser energy characterization) rather than efficacy-based acceptance criteria or results.

Efficacy is implicitly addressed by stating it has "identical laser output parameters" to the predicate, implying similar efficacy without explicitly stating performance metrics.

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

The document mentions "Usability testing that showed that all subjects were successful at determining who should use the device and on what anatomic locations the device should be used." It also states, "In addition, the intended users were successful at performing all critical tasks, with only one user failing in one of the tasks due to abandoning the instructions in the middle of the procedure."

• Sample Size for Test Set: The exact number of subjects for usability testing is not specified, only "all subjects" and "one user."
• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective).

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)

This information is not provided in the document. The usability testing seems to rely on user performance rather than expert-established ground truth related to clinical efficacy.

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

This information is not provided in the document.

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

There is no mention of a multi-reader multi-case (MRMC) study or any AI component in the Epilaser device. The device described is a direct-use laser hair removal system.

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

Not applicable. The Epilaser is a physical device used by a human, not an algorithm. The "standalone" concept for algorithms does not apply here.

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

For the usability testing, the "ground truth" was likely the successful completion of tasks by the users. For the substantial equivalence claim regarding efficacy, it relies on the predicate device's established efficacy, indirectly using its original "outcomes data" or clinical evidence, but no direct ground truth generation for the Epilaser's efficacy is described in this document.

8. The sample size for the training set

Not applicable. The document describes a physical medical device, not a machine learning algorithm requiring a "training set" in the computational sense.

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

Not applicable, as there is no mention of a training set for an algorithm.

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