(245 days)
The Medical Non-ablative Fractional Laser Systems (Model: WFB-01) is intended for use in dermatological procedures requiring fractional skin resurfacing and coagulation of soft tissue.
The Medical Non-ablative Fractional Laser Systems (Model: WFB-01) is intended for use in dermatological procedures requiring skin resurfacing and coagulation of soft tissue.
The Medical Non-ablative Fractional Laser Systems (Model: WFB-01) includes three main parts, Main Console, Connector and Scan Handpiece.
The main console is used for system control, such as control of user interface, power on/off and other functions, and also used as holder for other components.
The Connector is used to connect with accessories or power supplier, such as foot switch, pipeline holder, cold air device etc.
The Scan Handpiece is used to provide laser emission and graphic scanning functions. It provides three scan heads (AccuTip, EffiTip, GrowTip) for treatment areas.
This document is a 510(k) Summary for a medical device called "Medical Non-Ablative Fractional Laser Systems (Model: WFB-01)" by Wingderm Electro-Optics Ltd. It states that no clinical tests were conducted. Therefore, there is no information available in the provided text regarding acceptance criteria, device performance, sample sizes, ground truth, expert qualifications, or MRMC studies that would typically be associated with a clinical study.
The submission is based on substantial equivalence to a predicate device (Lumenis, Ltd.'s M22 And Resurfx Systems, K170060) through non-clinical testing.
Here's a breakdown of the information that is available, specifically highlighting the absence of clinical study data:
1. A table of acceptance criteria and the reported device performance
Since no clinical study was performed, there's no table of clinical acceptance criteria or reported clinical device performance based on human subjects. The table provided (Table 2 Performance Comparison) focuses on technical specifications and shows the proposed device's specifications are "SAME" or "Analysis" (meaning there's a difference but it's deemed not to affect safety/effectiveness) compared to the predicate device.
| ITEM | Proposed Device | Predicate Device
K170060 | Remark |
|------------------------------|-----------------------------------------------------------------|-------------------------------------------------------------------------------------------|----------|
| Wavelengths | 1550 nm | 1565 nm | SAME |
| Fluence | Up to 70 mJ per Micro-beam | Up to 70 mJ per Micro-beam | SAME |
| Laser Power | 15 W | 15 W | SAME |
| Dot Density
(Dot/cm²) | 500 | Up to 500 | SAME |
| Laser Beam
Diameter | 110 um | 110 um | SAME |
| Inter-beam
spacing | 0.4 mm - 1.0 mm | 0.4 mm - 1.0 mm | SAME |
| Beam diameter
variability | Fixed | Fixed | SAME |
| Pulse Duration | 10 ms | 10 ms | SAME |
| Type of laser | Er:Glass | Er:Glass | SAME |
| Tip treatment
Area | AccuTip: 10mmX10mm,
EffiTip: 20mmX20mm
GrowTip: 10mmX20mm | 18mm SapphireCool Tip
18mm Precision Tip | Analysis |
| Scanning shapes | Rectangle, Hexagon, Ellipse, Triangle,
Circle | Line, square, rectangle, circle, donut,
hexagon, vertical line, and vertical rectangle | Analysis |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable, as no clinical study was conducted.
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 clinical study was conducted with a test set requiring expert ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical study was conducted.
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. The device is a laser system, not an AI-assisted diagnostic tool. No MRMC study was mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The 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 clinical study was conducted. The "ground truth" for demonstrating substantial equivalence relied on non-clinical engineering and performance testing against recognized standards and comparison to a predicate device's specifications.
8. The sample size for the training set
Not applicable, as no clinical study was conducted or AI algorithm trained.
9. How the ground truth for the training set was established
Not applicable, as no clinical study was conducted or AI algorithm trained.
Summary based on the provided document:
The device, "Medical Non-Ablative Fractional Laser Systems (Model: WFB-01)," obtained 510(k) clearance by demonstrating substantial equivalence to a predicate device based on non-clinical testing. This included adherence to international standards for medical electrical equipment safety, electromagnetic compatibility, laser safety, and biocompatibility, as well as performance testing for energy output accuracy. No clinical studies were performed, and therefore, no clinical performance data, patient sample sizes, expert-established ground truth, or MRMC studies are discussed in this document.
§ 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.