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For the removal or lightening of unwanted hair without adjuvant preparation
For the removal or lightening of unwanted hair in the 1064nm mode only without adjuvant preparation using one or two treatments.

Medlite™ Q-Switched Nd:YAG Laser
Medlite™ IV Q-Switched Nd:YAG Laser

The provided text states that "Clinical data was provided to support the use of the Medlite™ Q-Switched Nd:YAG Laser Systems without preparatory lotion to safely remove or lighten unwanted hair without adverse clinical findings." However, it does not detail specific acceptance criteria or an explicit study proving these criteria were met. Therefore, most of the requested information cannot be extracted from the given text.

Here is what can be inferred or explicitly stated from the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: Not specified in the provided text.
• Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective or prospective).

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

• Number of Experts: Not specified in the provided text.
• Qualifications of Experts: Not specified in the provided text.

4. Adjudication method for the test set:

• Not specified in the provided text.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size:

• There is no mention of an MRMC comparative effectiveness study involving human readers with and without AI assistance. The device in question is a laser system, not an AI diagnostic tool.

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

• Not applicable. The device is a physical laser system, not an algorithm.

7. The type of ground truth used:

• Based on the statement "safely remove or lighten unwanted hair without adverse clinical findings," the ground truth appears to be based on clinical observation of hair removal/lightening and the absence of adverse events. Specific methods for assessing hair removal/lightening success or adverse events are not detailed.

8. The sample size for the training set:

• Not applicable, as this device is a laser system and typically does not have a "training set" in the AI sense. Clinical studies involve a cohort of patients. The sample size for the clinical study (which would be analogous to a test set in a device performance study) is not provided.

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

• Not applicable, as there is no "training set" in the context of this device.

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