COOLTOUCH ND: YAG LASER SYSTEM

• K Number: K030453
• Device Name: COOLTOUCH ND: YAG LASER SYSTEM
• Manufacturer: NEW STAR LASERS, INC.
• Date Cleared: 2003-05-12 ( 90 days)
• Product Code: GEX
• Regulation Number: 878.4810
• Type: Traditional
• Panel: SU
• Reference & Predicate Devices: K014128 , K022884

Intended Use

The CoolTouch® ND:YAG Laser System is indicated for:

1. treatment of back acne
2. treatment of atrophic acne scars

Device Description

The CoolTouch® Nd:YAG Laser Systems are ND:YAG lasers producing laser emission at 1320nm. The lasers consist of three interconnected section: The cabinet which houses the power supply, cooling system, microcontroller and the laser, the fiber optics and the handpiece.

AI/ML Overview

The provided text is a 510(k) summary for the CoolTouch® Nd:YAG Laser System. It explicitly states under the "Performance Data" section: "None".

This means that the submission does not include any performance data from a specific study to demonstrate that the device meets acceptance criteria. Instead, the conclusion is based on substantial equivalence to legally marketed predicate devices.

Therefore, many of the requested details regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth cannot be extracted from this document as no such study was presented.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

• Acceptance Criteria: Not explicitly stated as no performance study was conducted. Acceptance was based on substantial equivalence.
• Reported Device Performance: Not reported as no performance study was conducted.

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

• Not applicable, as no performance test set was used for this 510(k) submission.

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, as no ground truth for a test set was established for this 510(k) submission.

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

• Not applicable, as no test set requiring adjudication was used for this 510(k) submission.

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, and no comparative effectiveness study of this nature was conducted or submitted.

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, as no ground truth from a performance study was established for this 510(k) submission.

8. The sample size for the training set

• Not applicable, as no training set for an algorithm was used for this 510(k) submission (this is a physical device).

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

• Not applicable, as no training set was used for this 510(k) submission.

Summary based on the provided text:

The device's acceptance was based on its substantial equivalence to legally marketed predicate devices (Candela Smoothbeam™ Laser System, K014128 and K022884) for the treatment of back acne and atrophic acne scars. The document explicitly states "Performance Data: None," indicating that no clinical or performance study was submitted to demonstrate effectiveness or safety against predefined acceptance criteria.

Regulation Number and Section

§ 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.