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The CoolTouch LC160 CTEV Nd:YAG Laser System with the JouleTraker accessory is indicated for the treatment of reflux of great and small saphenous veins associated with varicose veins and varicosities.

The CoolTouch Nd:YAG Laser Systems are Nd:YAG lasers producing laser emission at 1320 nm. The lasers consist of a cabinet, which houses the power supply, cooling system, microcontroller and the laser, and the fiber optic. Accessories include a footswitch and a fiber optic pull-back device, the JouleTraker.

The provided text is for a 510(k) Premarket Notification for a laser system and explicitly states that no clinical performance data was submitted. Therefore, the device has not been "proven to meet acceptance criteria" through a study in this submission.

Based on the information provided in K062210:

1. Table of acceptance criteria and the reported device performance:

Since "No clinical performance data was submitted," there is no table of acceptance criteria and reported device performance to present. The submission relies solely on substantial equivalence to a predicate device.

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

Not applicable. No clinical performance data was submitted.

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

Not applicable. No clinical performance data was submitted.

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

Not applicable. No clinical performance data was submitted.

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. No clinical performance data was submitted. This device is a laser system, not an AI diagnostic tool involving human readers.

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

Not applicable. No clinical performance data was submitted. This device is a laser system.

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

Not applicable. No clinical performance data was submitted.

8. The sample size for the training set:

Not applicable. No clinical performance data was submitted. This device is a laser system, not an AI model requiring a training set.

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

Not applicable. No clinical performance data was submitted.

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