FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

Removal of unwanted hair, for stable long term, reduced hair growth when measured at 6, 9, and 12 months and for treatment of PFB (Pseudo Folliculitis Barbae). The laser is indicated for all skin types including tanned skin
Photocoagulation and hemostasis of pigmented and vascular lesions, such as, but not limited to, port wine stains, hemaongiomae, warts, telangiectasiae, rosacea, venous lake, leg veins and spider veins
Coagulation and hemostasis of soft tissue
Treatment of wrinkles
Treatment of mild to moderate inflammatory acne vulgaris

532nm wavelength in Q-switched mode (nominal delivered energy of 585nm and 650mm with the optional 585nm and 650nm dye hand-piece):

Removal of light ink (red, sky blue, green, tan, purple, and orange) tattoos
Treatment of vascular lesions including, but not limited to:
port wine birthmarks
telangiectasias
spider angioma
cherry angioma
spider nevus
Treatment of pigmented lesions including, but not limited to:
café-au-lait birthmarks
solar lentigines
senile lentigines
Becker's nevus
freckles
common nevus
nevus spilus
Treatment of seborrheic keratosis
Treatment of post inflammatory hyperpigmentation
Skin resurfacing procedures for the treatment of acne scars and wrinkles

Device Description

Not Found

AI/ML Overview

This is a 510(k) premarket notification for a laser surgical instrument, and as such, it primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing extensive clinical study data with acceptance criteria for a novel AI or diagnostic device. Therefore, a direct response to your detailed questions regarding acceptance criteria and study design (as might be found for a new diagnostic algorithm) is not present in the provided document.

However, I can extract the relevant information from the document and explain why other requested details are not applicable here.

Here's a breakdown based on the provided text:

Pertaining to the Device:

Trade/Device Name: Q-Switched Nd:YAG Laser System / IDS Model Q10 Q-Switched Nd: YAG Laser
Regulation Number: 21 CFR 878.4810
Regulation Name: Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology
Regulatory Class: Class II
Product Code: GEX

Analysis of your specific questions:

A table of acceptance criteria and the reported device performance:
- Not Applicable. This document is a 510(k) summary, which establishes substantial equivalence, not novel performance against specific acceptance criteria for a new diagnostic device. The device is a physical laser system, not an AI or diagnostic tool that would have performance metrics like sensitivity, specificity, or AUC against a ground truth. Its performance is inherent in its physical specifications and intended use, which are deemed equivalent to a predicate. The "Indications for Use" section outlines what the device is cleared to do, not its diagnostic performance.
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 this is a 510(k) for a physical laser device, it doesn't typically involve a "test set" in the context of evaluating an AI or diagnostic algorithm. Clinical data to support the indications may have been generated, but the specific details of a test set, its size, and provenance are not outlined in this 510(k) clearance letter. The FDA's review for substantial equivalence generally focuses on technological characteristics, safety, and effectiveness compared to a predicate, which might include relying on established literature or predicate device's safety record rather than a new clinical study with a "test set" for performance evaluation.
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. There is no "ground truth" establishment in the context of evaluating a diagnostic algorithm mentioned. The effectiveness of the laser for its stated indications (e.g., "removal of dark ink tattoos," "treatment of wrinkles") is generally supported by the predicate device's history and the understanding of laser-tissue interaction for these applications.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. No test set requiring expert adjudication is discussed in this 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:
- Not Applicable. This is a physical laser device, not an AI-assisted diagnostic tool. Therefore, MRMC studies and AI assistance comparisons are not relevant here.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This device is not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable. As explained, the concept of "ground truth" as applied to evaluating a diagnostic algorithm doesn't apply to this type of device and submission. Efficacy is generally demonstrated by clinical observations and comparisons to predicate devices over time, rather than a single "ground truth" metric.
The sample size for the training set:
- Not Applicable. Training sets are relevant for machine learning algorithms, which this device is not.
How the ground truth for the training set was established:
- Not Applicable. This device does not have a training set or associated ground truth.

In summary, the provided document is a 510(k) clearance letter for a Q-Switched Nd:YAG Laser System, indicating that the FDA has determined it is substantially equivalent to legally marketed predicate devices. The nature of this submission (a physical device, not a diagnostic or AI product) means that the requested details regarding acceptance criteria, test/training sets, ground truth, and expert evaluations in the context of diagnostic performance are not applicable or provided within this type of regulatory document.

Summary

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.