(134 days)
- · Tattoo Removal
- · Treatment of Vascular Lesions
- · Treatment of Pigmented Lesions,
- · Incision, Excision, Ablation, Vaporization of Soft Tissue for General Dermatology
1064nm:
Tattoo Removal: Dark ink: blue and black
Treatment of Pigmented Lesions: Nevus of ota
532nm:
Tattoo Removal: Light ink: red, Light ink: sky blue and green
Treatment of Vascular Lesions: Port wine birthmarks, Telangiectasias, Spider angioma, Cherry angioma, Spider nevi
Treatment of Pigmented Lesions: Café-au-lait birthmarks, Solar lentiginos, Senile lentiginos, Becker's nevi, Freckles, Nevus spilus
The Nd: YAG Laser System is based on the Q-Switched Nd:YAG (1064 nm) and frequency doubled KTP Nd:YAG (532 nm) laser technology. There is one optical cavity containing the Nd:YAG crystal. The frequency doubled KTP Nd:YAG wavelength is achieved by directing the Nd:YAG laser beam through a frequency doubling non-linear crystal. The Nd:YAG laser is activated by means of the use of flashlamp. A red diode aiming beam is reflected onto a coaxial beam path using a beamsplitter assembly. The combined therapeutic and aiming beams are guided by articulated arm to a focusing handpiece.
Both laser wavelengths share a common power supply, control system, and cooling system. The internal microprocessor can be directed to select either the Nd:YAG or the KTP Nd:YAG laser wavelength. The physician is able to select the desired wavelength and the related output energy ,spot size ,fluence via control panel.
The provided text describes a 510(k) premarket notification for the Nd: YAG Laser System (Qmetrx 1000 (Victory 11)) and assesses its substantial equivalence to predicate devices. However, it does not include information about specific acceptance criteria related to device performance in a clinical context (e.g., efficacy rates for tattoo removal, lesion clearance), nor does it detail a study proving the device meets such criteria through clinical endpoints.
Instead, the document focuses on non-clinical testing to ensure safety and compliance with recognized standards.
Here's an analysis of the provided information, addressing your questions based on what is available:
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided text, there are no specific performance acceptance criteria (e.g., target percentages for lesion clearance or tattoo fading) or a report of the device's clinical performance against such criteria. The "Testing" section focuses on compliance with international safety and electrical standards.
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance/Compliance |
|---|---|---|
| Safety and Electrical | IEC 60825-1 (Laser Safety) | Met |
| IEC 60601-2-22 (Therapeutic Laser Safety) | Met | |
| IEC 60601-1 (General Safety) | Met | |
| IEC 60601-1-2 (EMC) | Met | |
| UL 60601-1:2003 R6.03 (Electrical Safety) | Met | |
| Design Specifications | All design specifications | Met |
| Substantial Equivalence | Similar indications for use, design, features, safety compliance to predicate devices (K014234, K011677) | Determined by FDA |
2. Sample size used for the test set and the data provenance
The document explicitly states: "No Clinical Information is required." Therefore, there was no clinical test set in the traditional sense of patient data. The testing mentioned refers to laboratory testing for safety and design specifications. There is no information about data provenance (country of origin, retrospective/prospective) for a clinical test set because none was used.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
As no clinical test set was used, no experts were utilized to establish ground truth for a clinical test set. The grounding of the device's safety and effectiveness relies on compliance with engineering standards and comparison to previously approved predicate devices by the FDA.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical test set was used.
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-based diagnostic or assistive tool for human readers. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device (laser system), not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical testing, the "ground truth" was established by adherence to the specified international and national safety and performance standards (e.g., IEC 60825-1, IEC 60601 series, UL 60601-1). The device's "effectiveness" from the perspective of this 510(k) is primarily established through its substantial equivalence to the predicate devices, which means it shares similar indications for use, design, and functional features, implying similar efficacy outcomes based on the predicate's established history.
8. The sample size for the training set
Not applicable. There is no mention of a training set as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
Not applicable. There is no mention of a training set.
§ 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.