Search Results

DermaCool is intended for use with a laser or light source utilized for photo-coagulation of dermatological lesions and is a cooling device indicated for:

1. The reduction of pain,
2. Less discomfort,
3. Cooling of the skin prior, during and after laser or light treatment.

DermaCool™ is a skin-cooling device designed for lasers or light sources, which are used for skin treatment applications such as vascular lesions or hair removal. A piece of cooled sapphire window, or lens, which comes in contact with skin, performs skin cooling.

This document provides minimal information about the device, DermaCool™, a skin-cooling accessory for laser systems. It is primarily a 510(k) summary for regulatory clearance and does not contain data from a study demonstrating the device's performance against specific acceptance criteria.

Therefore, most of the requested information cannot be extracted from the provided text.

Here is what can be inferred or explicitly stated:

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

No acceptance criteria or reported device performance data are provided in the document. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than proving specific performance against predefined criteria through a study.

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

Not applicable. No study is described that would involve a test set.

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)

Not applicable. No study is described that would involve establishing ground truth by experts.

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

Not applicable. No study is described that would involve adjudication.

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. This device is a skin-cooling accessory, not an AI-based diagnostic tool, and therefore an MRMC study is not relevant to its function.

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

Not applicable. This device is a physical accessory, not an algorithm.

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

Not applicable. No study is described that would involve ground truth data.

8. The sample size for the training set

Not applicable. No study is described that would involve a training set.

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

Not applicable. No study is described that would involve training data with ground truth.

Summary of available information:

The document is a US FDA 510(k) premarket notification summary for the DermaCool™ skin-cooling device. It establishes substantial equivalence to existing legally marketed predicate devices (Candela laser accessories K974381 and K951033, and Cool Laser Optics, Inc. products). The indications for use are:

• Reduction of pain
• Less discomfort
• Cooling of the skin prior, during, and after laser or light treatment.

The 510(k) process focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device, rather than requiring extensive new clinical trials with acceptance criteria and performance metrics. Therefore, the information typically found in a study proving device performance against acceptance criteria is not present in this regulatory document.

Ask a specific question about this device