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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.

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The "GBOX-15A/15B" are indicated for use in surgical applications requiring the hemostasis, ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: aesthetic (dermatology and plastic surgery), gastroenterology, general surgery, genitourinary surgery (urology), qynecology (GYN), neurosurgery, otolaryngology (ENT), ophthalmology, arthroscopy, podiatry, pulmonology, and thoracic surgery; and Laser Assisted Lipolysis (980 nm only).

The "VELASII-30A/30B" are indicated for use in surgical applications requiring the vaporization, incision, excision, ablation, cutting and hemostasis, or coagulation of soft tissue in conjunction with endoscopic equipment for medical specialist including: Urology (BPH), Genitourinary (UJrology), Thoracic Surgery, Plastic Surgery and Dermatology, Aesthetics including vascular lesions and hair removal, General Surgery, Ophthalmology, Orthopedics, Podiatry, Arthroscopy, Spinal Surgery, Gynecology, Pulmonary Surgery, Neurosurgery (PLDD), Gastroenterology, Head/neck/ENT and Radiology Endovascular coagulation, Oral Surgery and Dental procedures, laser assisted lipolysis.

The "VELASII -60A/60B/60C" are indicated for use in surgical applications requiring the vaporization, incision, excision, ablation, cutting and hemostasis, or coagulation of soft tissue. Such as: Dermatology, Aesthetics, Plastic Surgery, Vascular Surgery, Podiatry, Endovenous Occlusion of the greater saphenous vein of the thigh in patients with superficial vein reflux.

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 are 810mm/980mm of GBOX-15A/15B, 810/980mm of VELAS II -30A/30B, 810/980/940nm of VELAS II -60A/60B/60C. 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 into " | " position. Immediately the power indicator will be green with the system fans working. At the same time, the LCD screen lights up as the picture shows below.

After finishing setting the parameters, press the "Ready" button and then the system will remind you to wear the safety goggles (protect wavelength from 800nm to 1100nm). At this time when you press down the footswitch, the laser will emit.

This document is a 510(k) Premarket Notification from Wuhan Gigaa Optronics Technology Company, Ltd. for their Medical Diode Laser Systems, including models GBOX-15A/15B, VELASII-30A/30B, and VELASII-60A/60B/60C. The purpose of a 510(k) submission is to demonstrate that the new device is "substantially equivalent" to a legally marketed predicate device, meaning it is as safe and effective.

The submission focuses on comparing the proposed devices to existing predicate devices rather than establishing novel acceptance criteria based on a specific clinical study of the proposed device's performance against a ground truth.

Here's an analysis based on the provided text, addressing your questions:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not present "acceptance criteria" in the typical sense of quantitative performance metrics (e.g., sensitivity, specificity, accuracy) that a device must meet in a direct study against a ground truth. Instead, it demonstrates "substantial equivalence" to predicate devices by comparing their specifications and intended uses. The "reported device performance" is largely framed within the context of these comparative specifications and adherence to recognized standards.

Here's a table summarizing the comparison, highlighting where the proposed devices align with or are similar to the predicate devices, which implicitly serves as the "acceptance criteria" for substantial equivalence.

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

The document describes non-clinical tests performed on the "GBOX" and "VELAS II" Medical Diode Laser Systems for safety and performance in accordance with various IEC and ISO standards. It also mentions "software verification has been carried out according to the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."

• Test Set: No explicit "test set" in the context of clinical data (e.g., patient cases, retrospective or prospective) is described for evaluating device performance against primary clinical endpoints. The testing described is primarily engineering and bench testing to demonstrate compliance with general safety and performance standards and comparison to predicate device specifications.
• Sample Size: Not applicable in the context of a clinical test set. The non-clinical tests would have involved specific units of the device.
• Data Provenance: The tests were performed by the manufacturer, Wuhan Gigaa Optronics Technology Co., Ltd. The document does not specify a country of origin for the non-clinical test data other than the manufacturer's location in China. The "tests" here refer to regulatory compliance and engineering evaluations, not clinical trials with human subjects.

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

This information is not provided as the submission is not based on a clinical study requiring ground truth establishment by experts. The "ground truth" for this submission is effectively the established safety and performance profile of the predicate devices and compliance with recognized international standards for medical electrical equipment and laser products.

4. Adjudication method for the test set

Not applicable. There is no clinical test set requiring expert adjudication described in the document.

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 medical diode laser system, not an AI-powered diagnostic or interpretive tool that would involve "human readers" or "AI assistance" in the sense of image analysis or diagnostic support. Therefore, an MRMC study is irrelevant to this submission.

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

Not applicable. This device is not an algorithm or AI system for diagnostic or interpretive purposes. It's a surgical laser system where the performance is physical (e.g., power output, wavelength, tissue interaction) and its operation is directly controlled by a human operator.

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

The "ground truth" for this 510(k) submission is primarily:

• Predicate Device Performance: The established safety and effectiveness of the legally marketed predicate devices to which the proposed devices are compared.
• Compliance with Recognized Standards: Adherence to international standards for medical electrical equipment, laser safety, and biological evaluation (e.g., IEC 60601 series, IEC 60825-1, ISO 10993 series).
• Engineering and Performance Specifications: The technical specifications (e.g., wavelength, output power, pulse width) are tested against internal design requirements and predicate device specifications.

There is no mention of ground truth established via expert consensus, pathology, or outcomes data from a clinical trial for the proposed device itself. The claim of "Substantial Equivalence" relies on demonstrating that the proposed device is sufficiently similar to devices already found safe and effective.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a "training set."

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

Not applicable. This is not an AI/ML device.

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