(85 days)
The Q-Switched Nd: YAG Laser Therapy System is indicated for use in tattoo removal, treatment of benign vascular lesions, treatment of benign pigmented lesions, incision, ablation, vaporization of soft tissue for general dermatology as follows:
1064nm: -Tattoo Removal Dark ink: blue and black. -Treatment of Benign Pigmented Lesions Nevus of ota.
532mm: -Tattoo Removal Light ink: red, Light ink: sky blue and green. - Treatment of Benign Vascular Lesions Port wine birthmarks: Telangiectasias; Spider angioma: Cherry angioma; Spider nevi. -Treatment of Benign Pigmented Lesions Cafe-au-lait birthmarks; Solar lentiginos; Senile lentiginos; Becker's nevi; Freckles; Nevus spilus.
The proposed device is a multi-wavelength, pulsed laser system designed for the treatment of benign pigmented lesions. The device can produce two wavelengths, 1064nm and 532nm, to treat different skin color. It consists of control panel module, main control module, laser power module, temperature and humidity control module and laser module. The physician is able to select the desired waveleneth and the related output energy via control panel.
The provided text describes a 510(k) submission for a Q Switched Nd: YAG Laser machine. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing clinical performance data against specific acceptance criteria for AI/ML devices. Therefore, much of the requested information regarding AI/ML device testing (e.g., sample size for test set, number of experts for ground truth, MRMC studies, standalone performance) is not applicable or available in this document.
However, I can extract information related to the device's technical specifications and the non-clinical tests performed to demonstrate its safety and effectiveness in comparison to the predicate device.
Here's the information as far as it can be extracted from the provided text:
1. A table of acceptance criteria and the reported device performance
For a 510(k) submission, the "acceptance criteria" are typically defined by the technical specifications and adherence to recognized standards, demonstrating performance comparable to a predicate device. The "reported device performance" is then the demonstrated compliance with these specifications and standards.
| Acceptance Criteria (Technical Specification/Standard Compliance) | Reported Device Performance (Proposed Device) | Predicate Device Specification |
|---|---|---|
| Product Code | GEX | GEX |
| Regulation Number | 21 CFR 878.4810 | 21 CFR 878.4810 |
| Class | Class II | Class II |
| Indications for Use | The Q-Switched Nd: YAG Laser Therapy System is indicated for use in tattoo removal, treatment of benign vascular lesions, treatment of benign pigmented lesions, incision, excision, ablation, vaporization of soft tissue for general dermatology as follows: 1064nm: -Tattoo Removal (Dark ink: blue and black). -Treatment of Benign Pigmented Lesions (Nevus of ota). 532nm: -Tattoo Removal (Light ink: red, Light ink: sky blue and green). -Treatment of Benign Vascular Lesions (Port wine birthmarks; Telangiectasias; Spider angioma; Cherry angioma; Spider nevi). -Treatment of Benign Pigmented Lesions (Cafe-au-lait birthmarks; Solar lentiginos; Senile lentiginos; Becker's nevi; Freckles; Nevus spilus). | The Q-Switched Nd: YAG Laser Therapy System (1064nm or 532nm) is indicated for use in tattoo removal, treatment of benign vascular lesions, treatment of benign pigmented lesions, incision, excision, ablation, vaporization of soft tissue for general dermatology as follows: 1064nm: -Tattoo Removal (Dark ink: blue and black). -Treatment of Benign Pigmented Lesions (Nevus of ota). 532nm: -Tattoo Removal (Light ink: red, Light ink: sky blue and green). -Treatment of Benign Vascular Lesions (Port wine birthmarks; Telangiectasias; Spider angioma; Cherry angioma; Spider nevi). -Treatment of Benign Pigmented Lesions (Cafe-au-lait birthmarks; Solar lentiginos; Senile lentiginos; Becker's nevi; Freckles; Nevus spilus). |
| Lamp Source | Xenon Lamp | Xenon Lamp |
| Energy Source | ND:YAG | ND:YAG |
| Laser Classification | Class 4 | Class 4 |
| Laser Wavelength | 1064nm, 532nm | 1064nm, 532nm |
| Max. Output Energy | 500mJ for 1064nm, 260mJ for 532nm | 500mJ for 1064nm, 250mJ for 532nm |
| Spot Size | 2-10mm | 2-10mm |
| Pulse Width | 6ns ± 1ns | 5ns ± 1ns or 5ns |
| Repetition Rate | 1-10Hz | 1-5Hz |
| Cooling method | internal distilled water circulating cooling | internal distilled water circulating cooling |
| Aiming beam wavelength | 635nm | 635nm |
| Aiming Beam | 0.1mW-5mW | 0.1mW-5mW |
| Laser output mode | Q-switched pulse | Q-switched pulse |
| Beam delivery | articulated arm light guide | articulated arm light guide |
| Patient contact material (Light guide arm) | Aluminum alloy | Steel, ABS |
| Biocompatibility (Cytotoxicity) | No Cytotoxicity (Conforms with ISO 10993-5:2009) | No Cytotoxicity |
| Biocompatibility (Sensitization) | No evidence of Sensitization (Conforms with ISO 10993-10:2010) | Conforms with ISO 19003 (presumably ISO 10993 per context) |
| Biocompatibility (Irritation) | No evidence of Irritation (Conforms with ISO 10993-10:2010) | No evidence of Irritation |
| Electrical Safety | Conforms with IEC 60601-1:2005+AMD1:2012 | Conforms with IEC 60601-1 |
| EMC | Conforms with IEC 60601-1-2:2014 | Conforms with IEC 60601-1-2 |
| Laser Safety | Conforms with IEC 60601-2-22:2012, IEC 60825-1:2014 | Conforms with IEC 60601-2-22, IEC 60825 |
2. Sample size used for the test set and the data provenance
The document states: "No clinical study is included in this submission." The testing described is non-clinical (laboratory/bench testing) verifying device specifications and adherence to standards. Therefore, an explicit "test set sample size" for patient data and "data provenance" (country of origin, retrospective/prospective) are not applicable to this type of submission. The tests involved physical device characteristics and materials.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable, as no clinical studies with human "test sets" or expert-established "ground truth" were part of this 510(k) submission.
4. Adjudication method for the test set
Not applicable, as no clinical studies with expert adjudication were part of 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 machine, not an AI-assisted diagnostic or therapeutic tool that would involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a physical laser machine, not an algorithm.
7. The type of ground truth used
For the non-clinical tests, the "ground truth" implicitly refers to the established scientific and engineering principles and the requirements defined by the international standards (e.g., ISO 10993 for biocompatibility, IEC 60601 series for electrical and laser safety). Device characteristics were measured against predefined specifications that are deemed safe and effective in comparison to the predicate device.
8. The sample size for the training set
Not applicable. This is not an AI/ML device, so no "training set" in that context exists.
9. How the ground truth for the training set was established
Not applicable for the same reason as above.
§ 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.