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The Medical Diode Laser ,Model S1Pro is indicated for the treatment of the saphenous veins associated with varicose veins and varicosities.

The Medical Diode Laser use a wavelength 1470nm Galium Aluminum Arsenide (GaAlAs) diode laser as the beam source. The laser utilizes a red (650nm) aiming beam diode to indicate the area to be irradiated by the laser beam. The Medical Diode Laser (model: S1Pro) is a compact diode laser with a LCD touchscreen for user control. The device is composed of main unit, foot switch, power cord and protective goggles. The fiber delivery system is not include in this device. The device accepts a fiber with single core of 400μm and 600um in diameter and with SMA905 connectors.

Here's a breakdown of the acceptance criteria and study information for the Medical Diode Laser, Model S1Pro, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the demonstration of substantial equivalence to the predicate device and compliance with relevant safety and performance standards. The "reported device performance" refers to the successful verification against these standards.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not explicitly stated for specific tests (e.g., how many units were tested for functional performance).
• Data Provenance: The studies are non-clinical bench tests and software verification and validation testing. There is no mention of human subject data, therefore, no country of origin is applicable in the usual sense for clinical trials. The tests were conducted by Wuhan Pioon Technology Co., Ltd.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable as the studies are non-clinical (bench testing, software V&V). Ground truth, in this context, would be defined by the technical specifications and standards (e.g., a laser's output power must be within a certain tolerance as per its design specification and relevant IEC standards).

4. Adjudication Method for the Test Set

This information is not applicable as the studies are non-clinical benchmarks against predetermined technical specifications and international standards.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, an MRMC comparative effectiveness study was not done. The submission explicitly states "Clinical data: Not applicable." This is a non-clinical submission for a medical device.

6. Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance)

• Yes, the performance data detailed are primarily standalone in nature. This refers to the device itself performing according to its design specifications and relevant safety/performance standards (electrical safety, EMC, laser safety, functional performance, and software V&V). There is no "algorithm" in the sense of AI/image analysis being evaluated, but rather the functional performance of the laser device.

7. Type of Ground Truth Used

The "ground truth" for the non-clinical studies described is:

• Technical Specifications: The device's own design specifications for parameters like wavelength, output power, pulse width, aiming beam power, dimensions, etc.
• International Consensus Standards: Compliance with standards such as IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, and IEC 60825-1.
• FDA Guidance: For software verification and validation, compliance with FDA's guidance for software in medical devices.

8. Sample Size for the Training Set

• This information is not applicable. There is no mention of a "training set" as this is not an AI/machine learning device that requires training data. The "training" of the device is its design and manufacturing to meet specifications.

9. How the Ground Truth for the Training Set Was Established

• This information is not applicable for the same reason as point 8.

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