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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 LASER THERMAL THERAPY KIT used to direct laser energy to soft tissue, to necrotize or coagulate soft tissue through interstitial irradiation in medicine and surgery in cardiovascular thoracic surgery (excluding the heart and the vessels in the perical sac), dermatology, ear-nose-throat surgery, gastroenterology, general surgery, gynecology, head and neck surgery, orthopedics, pulmonology, radiology, and urology, at a wavelength of 1064nm.

The LASER THERMAL THERAPY KIT is used to transfer laser energy from the laser unit to the tissue site for the treatment. The LASER THERMAL THERAPY KIT consist of a Fiber Optic for PLA (272μm core quartz fiber with distal end outer diameter 420um and NA 0.2) and an introducer needle (21G). The device is sterile and single use.

The provided text describes a 510(k) summary for the "LASER THERMAL THERAPY KIT" by Elesta SpA. This document outlines the device's technical characteristics and claims substantial equivalence to existing predicate devices. However, it does not contain details about specific acceptance criteria and a study proving the device meets those criteria in terms of clinical performance or diagnostic accuracy.

The non-clinical performance tests mentioned focus on engineering aspects like laser light transmission, power loss, mechanical and optical functionalities, sterilization, shelf-life, and biocompatibility. These are essential for device safety and basic functionality but do not relate to clinical effectiveness or user performance against predefined clinical criteria.

Therefore, I cannot provide the requested information regarding clinical acceptance criteria and a study demonstrating the device meets them from the given text.

Here's a breakdown of what can be extracted and what cannot:

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

• Cannot be provided. The document does not define clinical acceptance criteria for the device's performance in terms of treatment outcomes or diagnostic accuracy. The "reported device performance" referred to in the text relates to engineering tests (e.g., effectiveness and efficiency of laser light transmission, power loss, mechanical/optical functionalities, sterilization, shelf-life, biocompatibility).

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

• Cannot be provided. No clinical test set or data provenance is mentioned in the document. The tests described are engineering and laboratory-based.

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):

• Cannot be provided. No clinical test set, ground truth, or expert involvement is described.

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

• Cannot be provided. No clinical test set or adjudication method 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:

• Cannot be provided. This device is a laser thermal therapy kit, not an AI diagnostic or assistance tool for human readers. Therefore, an MRMC study is not applicable to its stated function, and no such study is mentioned.

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

• Cannot be provided. This device is a hardware component (fiber optic and introducer needle) for delivering laser energy, not a standalone algorithm.

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

• Cannot be provided. No clinical ground truth is discussed. The "ground truth" for the non-clinical tests would be the established engineering specifications and standards (e.g., power output measurements, ISO standards for sterilization).

8. The sample size for the training set:

• Cannot be provided. No training set for an algorithm is mentioned as this is a medical device hardware component.

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

• Cannot be provided. As above, no training set for an algorithm is mentioned.

In summary, the provided document focuses on substantiating equivalence to predicate devices based on design, intended use, technological characteristics, and non-clinical engineering and bench testing. It does not include information about clinical performance studies or specific acceptance criteria for treatment efficacy or diagnostic accuracy.

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The Fibers are indicated for use in general surgical applications for incision, vaporization, ablation, hemostasis or coagulation of soft tissue. It is also indicated for use in open or closed endoscopic applications including excision,tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors or lesions, tissue vaporization, hemostasis and or coagulation may be indicated.

The Adler MicroMed Laser Surgery Fibers have a wavelength range of 450 nm to 2100 nm, can be used in contact and non-contact mode and are indicated for use in general surgery, urology, gastroenterology, gynecology, gynecology, drmnology, vascular surgery, neurosurgery, plastic surgery, ENT and endovenous occlusion of the greater saphenous veni in the patient with superficial vein reflux and laser assisted lipolysis with a cleared compatible laser marketed for the mononed intended uses and using an SMA 905 connector.

The Adler MicroMed Laser Surgery Fibers are single use laser delivery devices provided sterile and intended for medical applications in various fields of laser surgerv.

The devices are based on a silica quartz glass core, have a length range of 6.5 feet (2 meters) to 9.8 feet (3 meters) and a wavelength range between 450 and 2100nm. The proximal end of the fibers is connected to a cleared laser system via an SMA 905 connector, while the distal end delivers the laser energy to the target tissue inn pulsed and continuous wave mode.

The distal end may have a rounded or conical silica cap, or non-capped tips, which may be flat, spherical, ball, conical or bended for the various intended uses and effects.

The Adler MicroMed Laser Surgery Fibers are medical devices designed for various surgical applications. The provided document, a 510(k) summary, focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove a device meets specific acceptance criteria based on performance metrics such as accuracy or efficacy in diagnosing conditions.

Therefore, many of the requested details about acceptance criteria, test set characteristics, expert involvement, and statistical comparisons (like MRMC studies) are not applicable or extractable from this document. The document describes non-clinical performance data conducted to establish that the device is as safe and effective as a predicate device, which is a different type of evaluation.

Here's an attempt to answer the questions based on the provided text, indicating when information is not available:

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

The document does not specify quantitative acceptance criteria or reported device performance in the typical sense of a clinical study measuring diagnostic accuracy or treatment efficacy against a predefined benchmark. Instead, it lists non-clinical performance tests conducted to demonstrate equivalence to a predicate device. The "performance" here refers to meeting safety and functional requirements rather than medical outcome metrics.

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

This information is not provided in the document. The listed "performance tests" are non-clinical (e.g., lab tests for sterilization, packaging, shelf-life, biocompatibility, and functional aspects). No "test set" in the context of patient data for a clinical performance study is mentioned.

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. The document does not describe a clinical study where experts would establish ground truth for a test set.

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

Not applicable. No clinical test set or adjudication method is mentioned.

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 surgery fiber, not an AI-assisted diagnostic tool. No MRMC comparative effectiveness study was performed or is relevant to this type of device based on the provided document.

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

Not applicable. This device is a laser surgery fiber and does not involve algorithms or human-in-the-loop performance in the context of diagnostic or interpretive tasks. The "functional" performance tests likely assessed the physical and operational characteristics of the fibers themselves.

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

Not applicable. The non-clinical performance tests for this device rely on established industry standards and methods for validating sterilization, packaging, shelf-life, biocompatibility, and functional energy transmission, rather than "ground truth" derived from patient outcomes or expert consensus in a clinical diagnostic setting.

8. The sample size for the training set

Not applicable. No training set is mentioned as this is not a machine learning or AI-based device.

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

Not applicable. There is no training set for this device.

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