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The "VELASI -15D" is indicated for the treatment of reflux of the saphenous veins associated with varicose veins and varicosities.

Medical diode laser systems are a kind of laser with semiconductor as working material. It consists of working material, cavity resonator and power source. The medical diode laser systems for this unit is GaAlAs diode bar, and the wavelength is 1470nm of VELAS II-15D. It features impact structure, high efficiency and long lifetime. The beam divergence angle is too large lead to poor beam quality. In order to better meet the needs of Laser Diode practical applications, Laser Diode carried beam shaping is very necessary. With the GIGAA'S unique fiber-coupling technology, the laser beam can be coupled efficiently into the fiber. To start the laser unit, turn the main switch ON and turn the key switch clockwise to "I" position. The power indicator will turn green immediately with the system fans working. At the same time, the LCD screen lights up. After the parameters setting is finished, press the "Ready" button and the system will remind you to wear the protective eyewear (protective wavelength is from 800nm to 1700mm). At this time when you press down the footswitch, the laser will emit.

The provided document is a 510(k) premarket notification for a medical device, specifically a Medical Diode Laser System (VELAS II -15D). It focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than defining specific performance acceptance criteria for the novel device itself.

Therefore, the document does not explicitly state specific acceptance criteria in terms of numerical performance thresholds (e.g., accuracy, sensitivity, specificity) for the device's clinical efficacy in treating reflux of saphenous veins. Instead, the "acceptance criteria" are implied by the demonstration of substantial equivalence to the predicate device, meaning the new device should perform as safely and effectively as the predicate.

The "study that proves the device meets the acceptance criteria" refers to the non-clinical testing performed to demonstrate adherence to relevant safety and performance standards, and a comparison presented in the "Summary of Substantial Equivalence" table.

Here's an analysis based on the information provided, though it will not contain specific performance metrics for clinical efficacy as none are present.

1. Table of Acceptance Criteria and the Reported Device Performance

As specific clinical performance acceptance criteria (e.g., success rate of vein closure, reduction in vein diameter) are not provided in this regulatory submission for the novel device, the "acceptance criteria" are inferred from the comparison to the predicate device, primarily focusing on technical specifications and safety standards.

Comparison to Predicate (K082225):

• Indications for Use: Same.
• Laser Type: Same.
• Components: Similar (Proposed device does not equip with fiber and handpiece initially, but recommends a specific disposable fiber set; predicate includes these components directly). The submission argues this does not affect safety and effectiveness.
• Wavelength: Similar ($1470nm \pm 10nm$ vs $1470nm \pm 30nm$). Proposed device has better accuracy.
• Output power: Same (1-15W).
• Operation mode: Same (CW, single pulse, repeat pulse).
• Pulse width: Similar (10ms-2.5s vs 0.01s-60s). Proposed device's range is contained within the predicate, deemed sufficient for intended use.
• Pulse repetition rate: Similar (0.2Hz-50Hz vs 0.01Hz-50Hz). Deemed not to affect safety and effectiveness.
• Application / Light delivery system: Similar. Proposed device is more detailed, fiber core diameter range is contained within predicate's general description, deemed sufficient for intended use.
• Aiming Beam: Similar. Proposed device's power range contains predicate's, deemed sufficient for intended use.
• Laser Class: Same (4).
• Operation interface: Same (Color LCD touch screen).
• Power Supply: Similar (350VA vs 450VA). Rated power difference not affecting safety and effectiveness.
• Safety classification: Same (Class I Type B).
• Dimensions & Weight: Similar, proposed device is bigger and heavier. Not noted to affect safety or effectiveness.
• Waterproof level: Same (IPX1 device, IPX8 footswitch).
• Standard Compliance: Same listed standards.
• Non-sterile: Same (Fiber sterilized by EO).
• Microprocessor Control: Same (Yes).

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

The document specifies non-clinical tests (compliance with standards) and software verification. It does not describe a clinical study or a test set in the sense of patient data. Therefore, information regarding "sample size used for the test set" and "data provenance" (country of origin, retrospective/prospective) is not applicable or not provided in this regulatory submission, which focuses on substantial equivalence based on technical specifications and international standards compliance.

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/study is described, the concept of establishing ground truth by experts is not applicable or not provided in this document. The "ground truth" for the device's technical specifications and safety is established by adherence to international standards and internal quality assurance procedures, as overseen by the manufacturer's technical staff and verified through testing.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as no clinical test set or study requiring adjudication is described.

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 surgical laser system, not an AI-assisted diagnostic tool or an imaging device involving "human readers." No MRMC study was mentioned or required for this type of submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a laser surgical instrument, meaning it inherently has a "human-in-the-loop" (the surgeon) performing the procedure. No standalone algorithm performance is relevant or described.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the technical performance aspects, the "ground truth" relies on:

• International standards compliance: Demonstrated by testing against IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, and IEC 60825-1.
• Software verification: According to FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.
• Predicate device's established safety and effectiveness: The core of the 510(k) submission is to argue that the new device is "substantially equivalent" to an already approved predicate device, implying its "ground truth" for safety and effectiveness is comparable to that of the predicate, which has presumably demonstrated its clinical efficacy through other means (e.g., initial clinical trials for its approval, or long-standing safe use).

No specific clinical "outcomes data" or "expert consensus" related to a new discrete clinical study for this specific device is provided in the document.

8. The sample size for the training set

Not applicable. This submission concerns a physical medical device (laser system), not an AI/machine learning model that requires a training set.

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

Not applicable, as there is no training set for an AI/machine learning model described.

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