(90 days)
The CoolTouch®, CoolTouch® II, and CoolTouch® CT3 ND:YAG Laser Systems are indicated for the treatment of mild to moderate inflammatory acne vulgaris.
The CoolTouch® Nd: YAG Laser Systems are ND: YAG lasers producing laser emission at 1320nm. The lasers consist of three interconnected section: a) The cabinet, which houses the power supply, cooling system , microcontroler and the laser, b) the fiber optics and c) the handpiece.
The provided text is a 510(k) premarket notification for three CoolTouch® Nd:YAG Laser Systems. It establishes substantial equivalence to a predicate device for the treatment of mild to moderate inflammatory acne vulgaris.
However, the document explicitly states "Performance Data: None" for the CoolTouch® Nd:YAG Laser Systems. Therefore, there is no information in this document to populate most of the requested fields regarding acceptance criteria and study details.
Based only on the provided text, here's what can be answered:
1. Table of Acceptance Criteria and Reported Device Performance:
No acceptance criteria or reported device performance for the CoolTouch® Nd:YAG Laser Systems are provided in this document. The submission states "Performance Data: None".
2. Sample size used for the test set and the data provenance:
Not applicable. No performance study data is presented.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. No performance study data is presented.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable. No performance study data is presented.
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 laser system, not an AI-assisted diagnostic tool. No MRMC study was conducted or reported.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a laser system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable. No performance study data is presented.
8. The sample size for the training set:
Not applicable. No training set is mentioned as this is a laser device, not a machine learning model.
9. How the ground truth for the training set was established:
Not applicable. No training set is mentioned.
§ 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.