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The Derma YAG Laser is indicated for benign vascular lesions and hair removal.

The Derma YAG Laser is a pulse Nd:YAG laser utilizing the Nd:YAG crystal as the lasing medium. It is a pulsed laser with a wavelength of 1064nm. Laser activation is by a footswitch. Overall weight of the laser is 63 kg, and the size is 80 cm x 42 cm x 80 cm (H x W x D). Electrical requirement is 220VAC, 12A, 50-60 Hz, single phase.

The provided 510(k) summary for the Derma YAG Laser (K062762) indicates that no clinical performance data was submitted. Therefore, there is no study described that proves the device meets specific acceptance criteria based on clinical outcomes.

The submission relies on demonstrating substantial equivalence to a predicate device (Cynosure Smartepil Laser) for the identical indications for use (benign vascular lesions and hair removal). This means that its safety and effectiveness are established by the predicate's known performance, rather than through new clinical studies for the Derma YAG itself.

Given this, I cannot complete a table of acceptance criteria and reported device performance from the provided text, as no such data is presented. Similarly, answers to the other numbered questions concerning clinical study details are not available in this document.

Here's what can be stated based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample size: Not applicable, as no clinical test set was described.
• Data provenance: Not applicable.

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

• Not applicable, as no clinical test set was described.

4. Adjudication method for the test set

• Not applicable, as no clinical test set was described.

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

• Not applicable, as this device is a laser for dermatological procedures and not an AI-assisted diagnostic tool requiring MRMC studies. No comparative effectiveness study of any kind was submitted.

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

• Not applicable, as this device is a laser for dermatological procedures and not an algorithm.

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

• Not applicable, as no clinical study or ground truth establishment was described for this device.

8. The sample size for the training set

• Not applicable, as no clinical study involving a training set was described.

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

• Not applicable, as no clinical study involving a training set or ground truth establishment was described.

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