(115 days)
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.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated as quantitative clinical performance metrics. The primary "acceptance" is demonstrating substantial equivalence to a legally marketed predicate device. | "The CoolTouch Varia Laser System and accessories are indicated for use in Dermatological applications for the treatment of fine lines and wrinkles." |
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.
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.