Search Results

The CoolTouch Varia Laser System and accessories are indicated for use in Dermatological applications for the treatment of fine lines and wrinkles.

The CoolTouch, Inc. CoolTouch "Varia" Nd:YAG Surgical Laser is a laser producing emissions at 1064nm. The lasers consist of several interconnected sections: the cabinet, which houses the power supply, cooling system, microcontroller, and the laser head, the fiber optics, and the handpiece. The systems provide safety features that are designed to protect the user and patient from high voltages and laser emissions.

This document, a 510(k) Summary of Safety and Effectiveness for the CoolTouch "Varia" laser system, primarily focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific clinical studies against acceptance criteria in the manner typically seen for novel diagnostic or AI-driven devices.

Therefore, many of the requested sections (e.g., sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC study details, ground truth types) are not applicable or not present in the provided text.

Based on the available text, here is the information that can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not list specific clinical acceptance criteria in terms of numerical performance metrics (e.g., sensitivity, specificity, accuracy, or a reduction percentage in wrinkles) that the device was tested against. Instead, it states compliance with regulatory standards and claims substantial equivalence to a predicate device for its intended use.

The document asserts that the device is "substantially equivalent to the cited legally marketed predicate device for the indications requested." |

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

Not applicable/Not provided. The document does not describe a clinical study with a "test set" in the context of evaluating performance against specific metrics. The claim is based on substantial equivalence, which typically involves demonstrating similar technological characteristics and intended use to an already approved device, rather than new clinical outcome data against set statistical criteria.

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

Not applicable/Not provided. As no specific clinical performance study with a test set generating a ground truth is described, this information is not present.

4. Adjudication method for the test set

Not applicable/Not provided. No clinical performance study with adjudication is 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/Not provided. This device is a laser system for dermatological applications, not an AI-driven diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this device and is not mentioned.

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

Not applicable/Not provided. This is a hardware laser system, not a software algorithm.

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

Not applicable/Not provided. No ground truth in the context of clinical performance evaluation is described. The "ground truth" for the submission is the regulatory acceptance of the predicate device for its specified indications.

8. The sample size for the training set

Not applicable/Not provided. This is a laser hardware system, not a machine learning algorithm that requires a "training set."

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

Not applicable/Not provided. As this is not an AI/ML device, the concept of a training set and its ground truth is not relevant.

Ask a specific question about this device

The CoolTouch NS-160 Nd: YAG Laser System is indicated for the treatment of reflux of the greater saphenous vein associated with varicose veins and varicosities.

The CoolTouch NS-160 Nd:YAG Laser System is an ND:YAG laser producing laser emission at 1320 nm. The laser consists of two sections: The cabinet, which houses the power supply, cooling system, microcontroller and the laser, and the fiber optic.

The provided text describes a 510(k) premarket notification for the CoolTouch NS-160 Nd:YAG Laser System. It states that "Clinical data produced results that indicate that the CoolTouch Nd:YAG Laser System is effective in the treatment of reflux of the greater saphenous vein associated with varicose veins and varicosities." However, it does not provide specific quantitative acceptance criteria or detailed results to fill out the table requested. It also lacks detailed methodology for the clinical study.

Therefore, many sections of your request cannot be fulfilled from the provided text.

Here's what can be extracted based on the given information:

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

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

• Sample Size: Not specified.
• Data Provenance: Not specified (e.g., country, retrospective/prospective). The document only states "Clinical data produced results."

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 specified. The document does not mention the use of experts for ground truth establishment.

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

• Not specified.

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 is a laser system, not an AI-assisted diagnostic device, and no MRMC study is mentioned.

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

• Not applicable. This is a laser system, not an algorithm.

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

• The text implies an evaluation of clinical outcomes ("effective in the treatment of reflux of the greater saphenous vein associated with varicose veins and varicosities"). However, the precise method of determining "ground truth" or clinical success (e.g., specific imaging follow-up, patient reported outcomes, physician assessment criteria) is not detailed.

8. The sample size for the training set

• Not applicable. This is a medical device (laser system), not a machine learning algorithm requiring a "training set."

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

• Not applicable. (See answer to #8).

Ask a specific question about this device