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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.

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The Diode Laser Therapy Systems are intended for hair reduction on all skin types (Fitzpatrick skin type I-VI).

Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.

The Diode Laser Therapy Systems has one model WLA-01, which mainly consist of the main console, treatment hand piece and a foot switch. The treat hand piece consist of the laser aperture, laser emission indicator, laser emission and hand piece display screen. The main console consist of power switch, hand piece holder, LCD touch screen, emergency shut off, hand-grip grab bar, connector hand piece, access door, observation Window, power input, inlet, air switch, gate interlock connector, foot switch connector, vent, drain and fans. The device has an embedded software named Diode Laser Therapy Systems Control Software.

The principle of laser hair removal is selective photothermolysis, 808nm wavelength effectively penetrates deep into and absorbed by the target chromophore. The adequate pulse duration, energy density and epidermal cooling ensure an adequate thermal damage to the target tissue without damaging the surrounding tissue to achieve effective hair removal.

The laser window of the hand piece will contact the skin directly and the laser output will contact the skin through the window. The Diode Laser Therapy System is suitable for use in healthcare facility/hospital.

Here's an analysis based on the provided text, outlining the acceptance criteria and study information for the Diode Laser Therapy Systems:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Test Set Sample Size: Not applicable. The submission states, "no clinical studies were needed to support this 510(k) Premarket Notification." The performance data submitted was for non-clinical aspects (biocompatibility, electrical safety, EMC, software V&V). These tests were conducted on the device itself or its components.
• Data Provenance: The origin of the non-clinical test data (biocompatibility, electrical safety, EMC, software V&V) is not specified as a country of origin in the provided text. It is assumed to be internal testing or conducted by accredited labs on behalf of the manufacturer, Wingderm Electro-Optics Ltd. (China). The data is described as "performance data were provided in support of the substantial equivalence determination," indicating it's retrospective relative to the 510(k) submission date.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable for the non-clinical tests.
• For clinical performance (hair reduction), the ground truth was established by prior studies or general acceptance of the predicate devices. The document does not specify experts or their qualifications for the predicate devices' studies.

4. Adjudication method for the test set

• Not applicable for the non-clinical tests.

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

• No MRMC comparative effectiveness study was done. This device is a laser therapy system, not an AI-assisted diagnostic or interpretive device that would typically involve human readers.

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 standalone algorithm. Its software is embedded and controls device function, but it doesn't operate as an "algorithm only" in the sense of AI or diagnostic software.

7. The type of ground truth used

• For non-clinical tests (biocompatibility, electrical safety, EMC, software V&V): The ground truth is the adherence to established international and national standards (e.g., ISO 10993, ANSI AAMI ES60601-1, IEC 60601-1-2, FDA software guidance). Passing these tests constitutes meeting the "ground truth" for safety and performance in these areas.
• For clinical performance (hair reduction): The ground truth for hair reduction efficacy is based on the performance of the predicate devices, which are legally marketed and presumed to achieve "permanent hair reduction" as defined. The substantial equivalence argument relies on the subject device operating on the same principles and having comparable technical specifications to achieve the same clinical outcome as the already-cleared predicates.

8. The sample size for the training set

• Not applicable. This device does not use machine learning or AI models that require a "training set" in the conventional sense. The "training" for the software would involve traditional software development and testing cycles, not data-driven machine learning.

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

• Not applicable (as the device does not use a "training set" in the AI/ML context).

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