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

Incision, excision, ablation, vaporization of soft tissue for general dermatology
Removal or lightening of unwanted hair with or without adjuvant preparation
Treatment melasma
Treatment of Pigmented Lesions
· nevus of ota
Skin resurfacing procedures for the treatment of acne scars and wrinkles
Tattoo Removal
dark ink: black, blue and brown

532 nm:

Treatment of Vascular Lesions
· port wine birthmarks
· telangiectaias
· spider angioma
· cherry angioma
· spider nevi
Treatment of Pigmented Lesions
· café-au-lait birthmarks
· solar lentiginos
· senile lentiginos
· becker's nevi
· freckles
nevus spilus
nevus of ota
Skin resurfacing procedures for the treatment of acne scars and wrinkles
Tattoo Removal
· light ink: red, sky blue, green, tan, purple, and orange

[Indications for use of FR mode in Nd:YAG Laser]

Removal of unwanted hair, for stable long term or permanent hair reduction and treatment of PFB (Pseudofollicultis Barbae). The laser is indicated for all skin types, Fitzpatrick I-VI, including tanned skin
Photocoagulation and hemostasis of pigmented and vascular lesions, such as but not limited to port wine stains, cherry angioma, Hemangiomas, warts, telangiectasias, rosacea, leg veins, and spider veins
Coagulation and hemostasis of soft tissue
Treatment of wrinkles
[Indications for use of Ti:Sapphire Laser]
785nm:
Removal of tattoos for Fitzpatrick skin types II-IV to treat the following tattoo colors: green and blue.
*Q-switched Nd:YAG Laser and Ti:Sapphire Laser cannot be used simultaneously *

Device Description

The flash lamp as a laser pumping source converts electric energy to light energy when a high voltage is applied. Nd:YAG crystal with the specific resonator emits an 1064nm single wavelength laser by absorbing light energy from the flash lamp. Q-switching mode is applied to the 1064nm laser resonator to amplify the 1064nm laser with about 10ns short pulse width.
The amplified O-switched 1064nm laser is secondarily amplified by an another Nd: YAG crystal and, then is converted to a second harmonic 532nm laser by passing through KTP crystal.
Finally a 785nm laser is emitted by the 785nm cavity with Ti:Sapphire crystal using the 532nm laser as a laser pumping source.
HELIOS 785 Pico Laser System can emit 1064nm, 532nm, and 785nm laser selectively by switching the wavelength conversion optical modules. The 1064nm laser is emitted by only Nd: Y AG crystal resonator and the 532nm laser can be emitted with the 1064nm laser and KTP crystal. The 785nm laser can be emitted by all optical modules.
The Q-switch mode normally produces polarized light, but it is also possible to set the FR(Free Running) mode, which emits light in all directions by removing the optics of the Q-switch module. Additionally, the RTP(Real Twin Pulse) mode can be set to generate two identical pulses with a very short interval instead of a single pulse.
The HELIOS 785 Pico laser system consists of:
a) A high voltage power supply, which converts and rectifies Alternating Current (AC) to provide regulated power for the flashlamp simmer current and main triggering pulse.
b) A cooling system consisting of an internal water flow circuit together with water-to-air heat exchanger.
c) The micro processor based controller unit, which regulates the functions of both lasers and allows parameter selection by the user.
d) The Nd: YAG laser + Ti:sapphire laser head.

AI/ML Overview

This document is a 510(k) summary for the HELIOS 785 Pico (1754V2) laser system. It describes the device's characteristics and compares it to predicate devices to establish substantial equivalence. However, it does not contain explicit acceptance criteria, performance data from a specific study to prove the device meets acceptance criteria, or details regarding ground truth establishment, expert adjudication, or sample sizes for training and test sets in the context of an AI/algorithm performance study.

The "Performance Data" section (page 13) refers to non-clinical tests for safety and performance according to consensus standards, but these are general engineering and safety standards for laser products, not typical performance metrics for an AI medical device like sensitivity, specificity, or accuracy derived from clinical data.

Therefore, many requested points cannot be extracted from the provided text.

Here is the information that can be extracted, with notes for the missing information:

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

This information is not provided in the document. The document refers to non-clinical safety and performance tests against consensus standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60825-1, ISO 14971, IEC 60601-1-6, IEC 60601-2-22) for the laser device itself, but it does not specify quantitative acceptance criteria or clinical performance metrics (like accuracy, sensitivity, specificity) for a specific medical indication, which would typically be included for an AI/algorithm-based device.

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

This information is not provided. The document details the laser device's technical specifications and intended uses, but it does not mention a test set or data related to any clinical evaluation for performance.

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)

This information is not provided. As there's no mention of a test set or clinical performance evaluation, there's no information on experts for ground truth establishment.

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

This information is not provided.

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

This information is not provided. The document is for a laser surgical instrument, not an AI-assisted diagnostic or treatment planning system that would typically undergo an MRMC study.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not provided. The device is a laser system, not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This information is not provided.

8. The sample size for the training set

This information is not provided.

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

This information is not provided.

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.