(90 days)
The CoolTouch Nd:YAG Laser Systems are indicated for the treatment of periorbital and perioral wrinkles.
The CoolTouch Nd:YAG Laser Systems are ND:YAG lasers producing laser emission at 1320 nm. The lasers consist of three interconnected sections: The cabinet, which houses the power supply, cooling system, microcontroller and the laser, the fiber optics, and the handpiece.
Here's an analysis of the provided text regarding the CoolTouch Nd:YAG Laser System's acceptance criteria and study information:
Based on the provided documents, there's no detailed information available about specific acceptance criteria or a comprehensive study report that would typically include the requested metrics for an AI/device performance evaluation. The document is a 510(k) premarket notification summary for a medical device (laser system), not an AI algorithm.
The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device, as required for medical device clearance in the US. It mentions "Clinical Performance Data," but only as a general statement: "Clinical trials produced results that indicate that that CoolTouch Nd:YAG Laser System is effective in the treatment of periorbital and perioral wrinkles." This is a summary and does not contain the specifics of a clinical study report.
Therefore, many of the requested details about acceptance criteria, study design for AI, sample sizes, ground truth, and expert involvement are not present in the provided text.
However, I can extract the available relevant information and present it in the requested format, clearly indicating where information is absent.
Acceptance Criteria and Device Performance
| Acceptance Criteria (If specified) | Reported Device Performance |
|---|---|
| Not specified in the document. | "Clinical trials produced results that indicate that that CoolTouch Nd:YAG Laser System is effective in the treatment of periorbital and perioral wrinkles." |
Study Details (Based on available information)
-
Sample size used for the test set and the data provenance:
This information is not provided in the given document. The document only states that "Clinical trials produced results," implying a test set was used, but details on size and provenance are absent. -
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the given document. The context of a physical laser device for wrinkle treatment suggests that "ground truth" would likely be clinical assessments of wrinkle reduction, possibly by physicians, but no specifics are given. -
Adjudication method for the test set:
This information is not provided in the given document. -
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:
This information is not applicable to the described device. The CoolTouch Nd:YAG Laser System is a physical laser device for treatment, not an AI algorithm, and therefore an MRMC study comparing human readers with and without AI assistance is not relevant to its function. -
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable to the described device, as it is a physical laser system, not a standalone algorithm. -
The type of ground truth used:
The document implicitly suggests the ground truth was based on clinical assessment of wrinkle reduction, as it states the device is "effective in the treatment of periorbital and perioral wrinkles." More specific details (e.g., objective measurements, subjective ratings, standardized scales) are not provided. -
The sample size for the training set:
This information is not provided in the given document. For a clinical trial of a laser device, there would be participants, but the term "training set" is typically used for machine learning models and is not directly applicable here. -
How the ground truth for the training set was established:
This information is not provided in the given document. Similar to point 7, the concept of a "training set" with established ground truth is more relevant to AI. For a medical device trial, the "ground truth" (i.e., the outcome measure of wrinkle reduction) would be established through clinical protocols, but the specifics are not detailed.
§ 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.