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The Medical Diode Laser Systems, include model: VELASⅡ-30A, GBOX-15AB, GBOX-20B, CHEESEⅡ-10B are intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for temporary relief of minor muscle and joint pain, muscle spasm, pain and stiffness associated with minor arthritis, promoting relaxation of muscle tissue, and to temporarily increase local blood circulation.

The Medical Diode Laser Systems, model: VELASⅡ-30B is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for temporary relief of minor muscle and joint pain, muscle spasm, pain and stiffness associated with minor arthritis, promoting relaxation of muscle tissue, and to temporarily increase local blood circulation.

The Medical Diode Laser Systems, model: VELASⅡ-30B is also indicated for use for the temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and T. mentagrophytes, and/or yeasts Candida albicans, etc.).

The "Medical Diode Laser Systems", include model: VELASⅡ-30B, VELASⅡ-30A, GBOX-15AB, GBOX-20B, CHEESEⅡ-10B which consist of three main components: Main device; Foot switch; Accessories.

Diode laser is a kind of laser with semiconductor as working material. It consists of working material, cavity resonator and power source.

The diode laser for this unit is GaAlAs diode bar, and the wavelength is 810nm and/or 980nm+/-10nm (pilot beam: 650nm+/-10nm). It features impact structure, high efficiency and long lifetime. Generally, the beam shall be emitted as the big beam divergence of the laser from the diode. With the unique fiber-coupling technology, the laser beam can be coupled efficiently into the fiber.

MCU (Micro Controller Unit) is the control center of system. MCU controls the drive board and temperature system by changing operating current. The operating power supply is the power source of the whole system. It supplies power for MCU, diode laser module by DC-DC conversion module and temp system by temp-control circuit. MCU controls the drive current of diode laser module by adjusting the DC-DC module and current-control circuit. The MCU has three external input sources: footswitch, remote interlock connector and information input from the touch units, it has one external output unit: display terminal. The diode laser module provides laser power output by fiber with optical fiber coupling system.

The provided FDA 510(k) clearance letter for the Gigaalaser Medical Diode Laser Systems does not contain a study that proves the device meets specific acceptance criteria related to its clinical efficacy. Instead, it demonstrates substantial equivalence to legally marketed predicate devices based on technological characteristics and safety standards.

The document focuses on non-clinical performance data (electrical safety, EMC, software V&V, mechanical/acoustic, animal, and clinical studies are noted as "not applicable" for this submission type) to argue that the proposed device is as safe and effective as its predicates.

Therefore, I cannot directly provide a table of acceptance criteria and reported device performance in the context of a clinical efficacy study, as such a study is explicitly stated as "not applicable" in this 510(k) submission. Similarly, details about sample size, expert ground truth, adjudication methods, MRMC studies, or standalone performance are not present because clinical efficacy testing was not required for this type of submission.

However, I can interpret the acceptance criteria in the context of a 510(k) submission as the requirements for demonstrating substantial equivalence to predicates, particularly regarding safety and technological characteristics. The "performance" reported is the demonstration that these criteria are met through compliance with recognized standards.

Here's an interpretation based on the provided document:

Overview of "Acceptance Criteria" for Substantial Equivalence and Device Performance (as demonstrated in the 510(k))

Within the context of a 510(k) submission, "acceptance criteria" are primarily established through demonstrating compliance with recognized performance standards and substantial equivalence to legally marketed predicate devices. The "study" proving this involves a comprehensive technical comparison and non-clinical testing.

The document explicitly states that clinical studies are "not applicable" for this 510(k) submission, meaning the acceptance criteria are focused on non-clinical performance and technological equivalence rather than empirical clinical efficacy data from a human trial.

1. Table of "Acceptance Criteria" (Substantial Equivalence) and "Reported Device Performance" (Demonstrated Compliance)

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

This document does not describe a "test set" in the context of clinical data for efficacy. The "testing" referred to is primarily bench testing and compliance validation with international safety and performance standards. Therefore, concepts like sample size for a patient test set and data provenance (country of origin, retrospective/prospective) are not applicable as no clinical study for efficacy was performed or presented.

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

Not applicable. As no clinical efficacy test set was used, there was no need for experts to establish ground truth on patient outcomes/diagnoses. The "ground truth" for the substantial equivalence argument relies on comparison to the published specifications and regulatory clearances of the predicate devices.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set requiring adjudication was used.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. The document explicitly states "Clinical Studies: It is not applicable." Therefore, no MRMC study for human reader improvement with AI assistance was conducted or reported.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No. This device is a laser system hardware, not an AI algorithm. Its performance is inherent to its physical output characteristics, not an algorithm's classification or detection performance.

7. The Type of Ground Truth Used

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

• Predicate Device Specifications: The established technical parameters and indications for use of the legally marketed predicate devices (K142078, K150138, K121363, K230047).
• Industry Standards: The requirements laid out in the cited IEC and other international standards for medical electrical equipment and laser safety.

8. The Sample Size for the Training Set

Not applicable. This is a hardware device, not a machine learning model that requires a training set of data.

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

Not applicable, as there is no training set for this type of device.

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The THEIA808 is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type 1-VI), including tanned skin.

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 is a kind of laser with semiconductor as working material. It consists of working material, cavity resonator and power source.

The diode laser for this unit is GaAlAs diode bar, and the wavelength is 808nm. It features impact structure, high efficiency and long lifetime. Generally the beam shall be emitted as the big beam divergence of the laser from the diode. With the unique fiber-coupling technology, the laser beam can be coupled efficiently into the handpiece.

When the THEIA808 works, the thermoelectric cooler cools the light outlet, and the main device measures the working temperature of the light outlet through the NTC temperature measuring resistor.

When the temperature reaches the minimum temperature, the TEC is controlled to stop working. The heat generated by thermoelectric cooler is conducted away by the water flow in the cooling module.

The energy of the laser is preferentially absorbed by the melanin in the hair, so that the hair follicle produces high heat. Thereby destroying the structure of the hair follicle, making the hair lose the ability to regenerate, and achieving the purpose of hair removal. The light outlet (treatment head) adopts a uniquely designed dynamic cooling device.

During the hair removal process, it can ensure that the epidermis will not be burned, so that the laser heat is limited to damage the hair follicles, while allowing the heat to diffuse from the epidermis, so that the epidermis can be anesthetized in a short time. The skin will not reach the damage threshold and can be protected from heat damage, thus ensuring a painless, fast and permanent hair removal effect.

This document is a 510(k) clearance letter for the Medical Diode Laser Systems (THEIA808). It does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria related to AI or algorithm performance.

The document specifically states:

• "No clinical study is included in this submission." This means there are no clinical trials proving efficacy or performance based on patient outcomes related to hair removal or reduction using this specific device.
• The clearance is based on "Substantial Equivalence" to a predicate device (K162659 Diode Laser Hair Removal System). This means the FDA determined the new device is as safe and effective as a legally marketed predicate device, primarily through non-clinical testing and comparison of specifications (e.g., wavelength, power, cooling methods).
• The non-clinical tests conducted verified compliance with electrical safety, EMC, laser safety, and biocompatibility standards. These are not performance metrics for hair removal efficacy or AI assistance.

Therefore, I cannot provide the requested information regarding acceptance criteria and study details for AI or algorithm performance because the provided text does not contain any such details. The device itself is a laser system, not an AI or algorithmic diagnostic/assistive device.

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(1) The Medical Diode Laser Systems, model: GBOX-6H, VELAS II-6H is indicated for use in surgical applications requiring the vaporization, excision, ablation, cutting and hemostasis, or coaqulation of soft tissue in conjunction with endoscopic equipment for medical specialist including: Urology, Thoracic Surgery, Plastic Surgery and Dermatology, General Surgery, Ophthalmology, Orthopedics, Podiatry, Arthroscopy, Spinal Surgery, Gynecology, Pulmonary Surgery, Neurosurgery, Gastroenterology, Head/neck/ENT and Radiology, Oral Surgery and Dental procedures. The output wavelength of model GBOX-6H and VELAS II -6H is 1940nm.

(2) The Medical Diode Laser Systems, model: GBOX-10D, GBOX-12D is indicated for use in surgical applications requiring the vaporization, excision, ablation, cutting and hemostasis, or coagulation of soft tissue in conjunction with endloscopic equipment for medical specialist including: Urology, Thoracic Surgery, Plastic Surgery and Dermatology, General Surgery, Ophthalmology, Orthopedics, Podiatry, Arthroscopy, Spinal Surgery, Gynecology, Pulmonary Surgery, Neurosurgery, Gastroenterology, Head/neck/ENT and Radiology, Oral Surgery and Dental procedures. The output wavelength of model GBOX-10D and GBOX-12D is 1470nm.

(3) The Medical Diode Laser Systems, model: GBOX-15D, VELAS II -15D is indicated for use in endovenous occlusion of the greater saphenous vein in patients with superficial vein reflux. The GBOX-15D, VELAS II - 15D is further indicated for laser assisted lipolysis. The output wavelength of model GBOX-15D and VELAS II -15D is 1470nm.

(4) The Medical Diode Laser Systems, model: VELAS Pro-30B15D is indicated for use in surgical applications requiring the vaporization, incision, ablation, cutting and hemostasis, or coagulation of soft tissue in conjunction with endoscopic equipment for medical specialist including: Urology, Thoracic Surgery, Plastic Surgery and Dermatology, General Surgery, Ophthalmology, Orthopedics, Podiatry, Arthroscopy, Spinal Surgery, Gynecology, Pulmonary Surgery, Neurosurgery, Gastroenterology, Head/neck/ENT and Radiology, Oral Surgery and Dental procedures, Endovascular coagulation and endovenous occlusion of the greater saphenous vein in patients with superficial vein reflux. Medical Diode Laser Systems, model: VELAS Pro-30B15D is further indicated for laser assisted lipolysis. The output wavelength of model VELAS Pro-30B15D is 980nm or 1470nm.

The "Medical Diode Laser Systems", include model: GBOX-6H, VELAS II -6H, GBOX-10D, GBOX-12D, GBOX-15D, VELAS II-15D, VELAS Pro-30B15D which consist of three main components: Main device; Foot switch; Accessories. Diode laser is a kind of laser with semiconductor as working material. It consists of working material, cavity resonator and power source. The diode laser for this unit is GaAlAs diode bar, and the wavelength is 1940nm for GBOX-6H, VELAS II -6H; 1470nm for GBOX-10D, GBOX-12D, GBOX-15D, VELAS III-15D; 980nm or 1470nm for VELAS Pro-30B15D. It features impact structure, high efficiency and long lifetime. Generally, the beam shall be emitted as the big beam divergence of the laser from the diode. With the unique fiber-coupling technology, the laser beam can be coupled efficiently into the fiber. MCU (Micro Controller Unit) is the control center of system. MCU controls the drive board and temperature system by changing operating current. The operating power supply is the power source of the whole system. It supplies power for MCU, diode laser module by DC-DC conversion module and temp system by temp-control circuit. MCU controls the drive current of diode laser module by adjusting the DC-DC module and current-control circuit. The MCU has three external input sources: footswitch, remote interlock connector and information input from the touch units, it has one external output unit: display terminal. The diode laser module provides laser power output by fiber with optical fiber coupling system.

The provided document is a 510(k) summary for Medical Diode Laser Systems. It focuses on establishing substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study demonstrating the device meets those criteria in terms of clinical performance. The document primarily discusses the similarity of the proposed device to predicate devices. Therefore, much of the requested information cannot be extracted directly from this type of regulatory submission.

Here's a breakdown of what can be inferred or explicitly stated:

1. A table of acceptance criteria and the reported device performance

The document does not present explicit acceptance criteria for clinical performance (e.g., specific efficacy rates or safety profiles) for the proposed device, nor does it report its performance against such criteria. Instead, it compares the technological characteristics of the proposed device to predicate devices. The "acceptance criteria" here are implicitly meeting the performance characteristics of the predicate devices to prove substantial equivalence.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document explicitly states: "Animal Study - It is not applicable." and "Clinical Studies - It is not applicable." This indicates that no clinical "test set" (i.e., patient data for direct performance evaluation) was used for this 510(k) submission. The data provenance is therefore not relevant in this context.

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)

Since no clinical studies or test sets with patient data were conducted for this submission, there were no experts used to establish ground truth for such a test set. The submission relies on establishing equivalence to legally marketed predicate devices, implying their established safety and efficacy.

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

Not applicable, as no clinical test set was used.

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 laser system, not an AI-powered diagnostic tool, and no MRMC studies were mentioned.

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

Not applicable. This is a hardware medical device, not an algorithm.

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

Not applicable, as no clinical studies requiring a ground truth for performance evaluation were conducted. The "ground truth" in this context is the safety and efficacy profiles of the predicate devices as legally marketed.

8. The sample size for the training set

Not applicable, as this is a hardware medical device, not an AI/ML algorithm requiring a training set.

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

Not applicable, as this is a hardware medical device.

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The intended use of the "CHARISMA" is:
-Dermatological procedures requiring coagulation of soft tissue and skin resurfacing procedures. further indicated for treatment of benign pigmented lesions, such as, but not limited to lentigines (age spots), solar lentigos (sun spots), melasma, dyschromia, and for treatment of facial wrinkles and fine lines.
-Incision, excision, ablation, vaporization, hemostasis and/or coagulation of soft tissue
-Endovascular coagulation and endovenous occlusion of the greatest saphenous vein in patients with superficial vein reflux
-Further indicated for laser assisted lipolysis.

The intended use of the "REGAL" is:
-Incision, excision, ablation, vaporization, hemostasis and/or coagulation of soft tissue
-Endovascular coagulation and endovenous occlusion of the greatest saphenous vein in patients with superficial vein reflux
-Further indicated for laser assisted lipolysis.

Diode laser is a kind of laser with semiconductor as working material. It consists of working material, cavity resonator and power source. The diode laser for this unit is GaAlAs diode bar, and the wavelength is 1470nm. It features impact structure, high efficiency and long lifetime. Generally, the beam shall be emitted as the big beam divergence of the laser from the diode. With the GIGAA'S unique fiber-coupling technology, the laser beam can be coupled efficiently into the fiber. MCU (Micro Controller Unit) is the control center of system. MCU controls the drive board and temperature system by changing operating current. The operating power supply is the power source of the whole system, it supplies power for MCU, diode laser module by DC-DC conversion module and temp-control circuit. MCU controls the drive current of diode laser module by adjusting the DC-DC module and current-control circuit. The MCU has three external input sources: footswitch, remote interlock connector and information input from the touch units, it has one external output unit: display terminal. The diode laser module provides laser power output by fiber with optical fiber coupling system.

The document provided is a 510(k) premarket notification for two medical diode laser systems, CHARISMA and REGAL. It aims to demonstrate substantial equivalence to legally marketed predicate devices, not to prove the device meets specific acceptance criteria through a clinical study. Therefore, much of the requested information regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth cannot be extracted from this document in the typical sense of a clinical performance study for an AI/software device.

However, I can provide information on the non-clinical tests performed to demonstrate safety and performance equivalence, as these serve as the "acceptance criteria" for this type of submission.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

For this 510(k) submission, the "acceptance criteria" are compliance with established electrical safety, EMC, and laser safety standards, as well as satisfactory software verification and validation. The "reported device performance" is the demonstration of compliance through non-clinical testing.

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

• Sample Size: Not applicable. The testing described is non-clinical, involving the physical device and its software being tested against engineering and safety standards, rather than a "test set" of patient data or samples.
• Data Provenance: Not applicable. The testing involves the device itself and its components, not patient data.

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

Not applicable. This is a non-clinical submission. Ground truth, in the context of clinical studies for AI/software, refers to definitive diagnoses or measurements. Here, the "ground truth" is compliance with international safety and performance standards. The "experts" involved would be the engineers and quality assurance personnel conducting and verifying the tests, but their specific number and qualifications are not detailed in this document.

4. Adjudication Method for the Test Set

Not applicable. There is no "adjudication method" in the sense of resolving discrepancies in expert opinions on patient data. Compliance with standards is typically determined by objective measurements and verification protocols.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document explicitly states under "VIII Clinical Testing" that it "is not applicable." This type of study is usually performed for diagnostic AI devices where human performance with and without AI assistance is being compared.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

No, a standalone performance study in the context of AI/software algorithm only was not done. The device is a physical medical laser system, and the non-clinical tests assess the safety and performance of the hardware and integrated software, not a standalone algorithm.

7. The Type of Ground Truth Used

As this is a non-clinical submission, the "ground truth" is compliance with recognized international safety and performance standards (IEC 60601-1, IEC 60601-1-2, IEC 60825-1, IEC 60601-2-22) and FDA guidance for software. These standards define the acceptable limits and behaviors for medical electrical equipment, laser products, and software.

8. The Sample Size for the Training Set

Not applicable. This document describes a medical device's safety and performance testing for regulatory clearance, not the development or training of an AI algorithm. Therefore, there is no "training set" in the context of machine learning.

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

Not applicable, as there is no training set mentioned or implied in this regulatory submission.

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Medical Diode Laser Systems are intended for intra- and extra-oral surgery including incision, excision, hemostasis, coagulation and vaporization of soft tissue including marginal and epithelial lining of free gingiva and are indicated for: frenectomy; frenotomy; biopsy; operculectomy; implant recovery; gingivoplasty; gingivoplasty; gingival troughing; crown lengthening; hemostasis of donor site; removal of granulation tissue; laser assisted flap surgery;debridement of diseased epithelial lining; incisions and draining of abscesses; tissue retraction for impressions;papillectorny; vestibuloplasty ; excision of lesions; exposure of unerupted partially erupted teeth; removal of hyperplastic tissues; treatment of aphthous ulcers; leukoplakia; laser removal of diseased, inflamed and necrosed soft tissue within the periodontal pocket; sulcular debridement (removal of diseased, inflamed and necrosed soft tissue in the periodontal pocket to improve clinical indices including gingival bleeding index, probe depth, attachment loss and tooth inability); pulpotomy; pulpotomy as adjunct to root canal therapy; fibroma removal; gingival incision and excision; treatment of canker sores; herpetic ulcers of the oral mucosa; laser soft tissue curettage; reduction of gingival hypertrophy.

Whitening: Medical Diode Laser Systems are indicated for light activation materials for teeth whitening and for laser-assisted whitening/bleaching of teeth.

Low Level Laser Therapy: Medical Diode Laser Systems are intended to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffins pain, or muscle spasm, and for the temporary increase in local blood circulation and/or temporary relaxation of muscles.

The Medical Diode Laser System is a compact, air-cooled unit. It is a complete self-contained instrument, which includes a high efficiency power supply, a microprocessor controlled, adjustable light output with automatic power stabilization, (fan cooled), as well as a switch panel and LCD screen display panel designed to be user friendly. The system includes high power lasers, safety features and an SMA fiber output connector. The system includes a Lithium battery, it can work 1hour when not external power input at maximum power output in pulse or CW but intermittent mode. The diodes are made from GaAlAs semiconductor material for high output and superior reliability. The diode lasers are enclosed in a rugged, factory-aligned, replaceable, environmentally protective module. High-capacity fans eliminate the need for water-cooling, and assure low maintenance and reliable laser operation. The diodes convert electric energy into coherent laser radiation with a wavelength of 810nm or 980nm+/-10nm (pilot beam: 650nm+/-10nm).

This document is a 510(k) premarket notification for a medical device (Medical Diode Laser Systems) and explicitly states that no clinical testing was performed. Therefore, the request for "acceptance criteria and the study that proves the device meets the acceptance criteria" cannot be fully answered as it pertains to clinical performance and AI integration.

The provided document focuses on demonstrating substantial equivalence to predicate devices primarily through non-clinical testing (electrical safety, EMC, laser safety standards, and software verification). There is no mention of AI/ML, human-in-the-loop performance studies, or ground truth establishment based on expert consensus, pathology, or outcomes data, which are typical requirements for AI/ML device clearances.

Based on the provided text, here's what can be inferred/extracted and what cannot be answered:

1. Table of acceptance criteria and the reported device performance:

Since no clinical or AI performance study was presented, the "acceptance criteria" here refer to conformance with established safety and performance standards for laser medical devices.

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The "CHERYLAS-15N and CHERYLAS-20N" are indicated for the treatment of reflux of the saphenous veins associated with varicose veins and varicosities.

Diode laser is a kind of laser with semiconductor as working material. It consists of working material, cavity resonator and power source.The diode laser for this unit is GaAlAs diode bar, and the wavelength is 1470mm. It features impact structure, high efficiency and long lifetime. Generally the beam shall be shamed as the big beam divergence of the laser from the diode. When the coaxiality of laser and fiber meet the requirements, the laser beam can be coupled efficiently into the fiber.

The block diagram shows how the diode laser system works. MCU (Micro Controller Unit) is the control center of system. MCU controls the drive board and temperature system by changing operating current. The operating power supply is the power source of the whole system, it supplies power for MCU, diode laser module by DC-DC conversion module and temp system by temp-control circuit. MCU controls the drive current of diode laser module by adjusting the DC-DC module and current-control circuit. The MCU has three external input sources: footswitch, remote interlock and information input from the touch units, it has one external output unit: display terminal. The diode laser module provides laser power output by fiber with optical fiber coupling system. The system can test and calibrate power by the calibration and feedback unit.

The provided document is a 510(k) premarket notification for a medical device (Medical Diode Laser Systems) and primarily focuses on proving substantial equivalence to a predicate device based on technical characteristics and adherence to safety standards. It explicitly states "Clinical data: Not applicable." Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving a device meets those criteria, specifically concerning performance metrics like sensitivity, specificity, or the improvement of human readers with AI assistance.

The information provided pertains to the device's technical specifications, intended use, and comparison to a predicate device, focusing on safety and technological equivalence rather than AI/algorithm performance.

To answer your request, the document would need to include details about a clinical study or a robust non-clinical performance study with specific metrics, a test set, ground truth establishment, and statistical analysis, which is absent.

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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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