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The BWF-5 Medical Laser Series (810nm, 930nm, 1080nm and 1320nm) are intended for delivery of laser light to soft tissue in the contact or non-contact mode during surgical procedures, including via endoscopes, introducers, or catheters. The BWF-5 Medical Laser Series are generally indicated for incision, excision, vaporization, ablation, hemostasis or coagulation of soft tissue in ear, nose and throat and oral surgery (otolary). And and procedures, arthroscopy, gastroenterology, general surgery, dermatology, glastic, sugery, podiatry, urology, gynecology, neurosurgery (peripheral nervous system), pulmonary surgery and thoracic surgery. The device is specifically indicated for use as follows:

LASER 980nm:
Indicated for use with the VARI-LASE Procedure Kit in the Endovascular coagulation of the Greater Saphenous Vein (GSV) of the thigh in patients with Superficial Vein Reflux.

LASER 1320mm:
Indicated for use with the VARI-LASE Procedure Kit in the treatment of reflux of great saphenous veins associated with varicose veins and varicosities.

LASER 810nm:
Indicated for use in the treatment of varicose veins and varicosities associated with superficial reflux of the Great Saphenous Vein and for treatment of incompetence and reflux of superficial veins in the lower extremity.

Not Found

The provided document is a 510(k) clearance letter from the FDA for the BWF-5 Medical Laser Series. It does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or any details related to AI or MRMC studies.

Therefore, I cannot provide the requested information based on the given text. This document is a regulatory approval notice, not a study report.

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The BWF-5 Medical Laser Series (810nm, 930nm, 980nm, 1080nm and 1320nm) are intended for delivery of laser light to soft tissue in the contact or non-contact mode during surgical procedures, including via endoscopes, introducers, or catheters. The BWF-5 Medical Laser Series are generally indicated for incision, excision, vaporization, ablation, hemostasis or coagulation of soft tissue in ear, nose and throat and oral surgery (otolaryngology), dental procedures, arthroscopy, gastroenterology, general surgery, dermatology, plastic surgery, podiatry, urology, gynecology, neurosurgery (peripheral nervous system), pulmonary surgery and thoracic surgery.

The device is specifically indicated for use as follows:

LASER 980nm:
Indicated for use with the VARI-LASE Procedure Kit in the Endovascular coagulation of the Greater Saphenous Vein (GSV) of the thigh in patients with Superficial Vein Reflux.

LASER 1320nm:
Indicated for use with the VARI-LASE Procedure Kit in the treatment of reflux of great saphenous veins associated with varicose veins and varicosities.

BWF-5 Medical Laser Series are compact medical laser systems. The laser light delivery system consists of a flexible optical fiber. Activation occurs when the operator enables the laser and presses the foot switch. Release the foot switch to deactivate the laser. Depending on laser system configuration, the foot switch can function as on/off switch. A touch-screen display panel allows the operator to adjust or set laser output level. The laser can operate in continuous wave mode or controlled pulse mode.

Here's an analysis of the provided text regarding the LiteCure, LLC BWF-5 Medical Laser Series, focusing on acceptance criteria and study details.

Based solely on the provided text, there is no information available about a separate study that proves the device meets specific acceptance criteria in terms of clinical performance, diagnostic accuracy, or comparative effectiveness with human readers.

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices, not on proving device performance through a clinical study with detailed acceptance criteria.

Therefore, many of your requested items cannot be fulfilled from this document. However, I can provide what is available.

Acceptance Criteria and Reported Device Performance

The concept of "acceptance criteria" in this 510(k) document refers to the device's compliance with safety and technical standards, and its substantial equivalence to predicate devices, rather than clinical performance metrics. The "reported device performance" is essentially that it meets these standards and is equivalent.

Study Information (Based on Available Text)

Unfortunately, the provided document does not describe a clinical study or performance study that would typically involve a test set, experts, ground truth, or comparative effectiveness measurements for an AI/device performance. The 510(k) summary focuses on demonstrating substantial equivalence to existing, legally marketed predicate devices, primarily through engineering specifications and adherence to recognized standards.

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

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

   • Not applicable / Not provided. The document does not describe a clinical performance study with a test set.

2. 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 / Not provided. This information would be relevant to a performance study, which is not described here.

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

   • Not applicable / Not provided. This is relevant for studies involving human interpretation or performance evaluation, which is not described.

4. 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:

   • No. The document does not describe an MRMC study. This device is a laser system, not an AI-assisted diagnostic or interpretive tool that would typically involve comparing human reader performance with and without AI.

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

   • Not applicable / Not provided. Given that this is a surgical laser device, "standalone algorithm performance" is not a relevant concept in the context of this 510(k). The device performs physical actions (laser light delivery for incision, excision, etc.), not algorithmic analysis.

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

   • Not applicable / Not provided. There is no described performance study requiring a ground truth for clinical outcomes. The "ground truth" for the 510(k) process is essentially compliance with engineering standards and demonstration of substantial equivalence.

7. The sample size for the training set:

   • Not applicable / Not provided. This device is a laser hardware system, not an AI/machine learning algorithm that requires a "training set."

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

   • Not applicable / Not provided. As there is no training set for an algorithm, this question is not relevant to the information provided.

Conclusion:

The provided 510(k) summary for the LiteCure, LLC BWF-5 Medical Laser Series primarily demonstrates the device's substantial equivalence to predicate devices and adherence to relevant safety and performance standards (like IEC and CFR). It does not contain information about a clinical performance study with detailed acceptance criteria, test sets, expert adjudication, or AI performance metrics as these are not typically required for a device of this nature to achieve 510(k) clearance by demonstrating substantial equivalence.

Ask a specific question about this device

The BWF-5 Medical Laser Series are intended for delivery of laser light to soft tissue in the contact or non-contact mode during surgical procedures, including via endoscopes, introducers, or catheters. The BWF-5 Medical Laser Series are generally indicated for incision, excision, vaporization, ablation, hemostasis or coagulation of soft tissue in ear, nose and throat and oral surgery (otolaryngology), dental procedures, arthroscopy, gastroenterology, general surgery, dermatology, plastic surgery, podiatry, urology, gynecology, neurosurgery (peripheral nervous system), pulmonary surgery and thoracic surgery.

BWF-5 Solid-State Medical Laser Series are highly reliable, compact and easy to operate medical laser systems. The cutting edge control technology provides user a high reliable and maintenance free system. The laser light delivery system consists of a flexible optical fiber threaded through a lightweight hand piece. Activation occurs when the operator enables the laser and presses the foot switch. Release the foot switch to deactivate the laser. Depending on laser system configuration, the foot switch can function as on/off switch. A convenient and easy-to-use touch-screen display panel allows the operator to adjust or set laser output level with minimal effort. The laser can operate in continuous wave mode or controlled pulse mode. The device features multiple user-programmable presets for storing frequently used treatment parameters.

The provided text is a 510(k) summary for a BWF-5 Medical Laser Series. It details the device's technical characteristics, intended use, and substantial equivalence to predicate devices. However, it does not contain any information about acceptance criteria, device performance metrics, or any studies proving the device meets acceptance criteria.

The document primarily focuses on:

• Identifying the applicant and device.
• Classifying the device and listing predicate devices.
• Describing the device's function and intended use.
• Listing warnings and cautions for its use.
• Stating that the device has the "same intended use and the same technological characteristics as the predicate devices" and that identified differences are "minor and are each within the specifications listed by the predicate device and does not raise any concerns regarding the overall safety and effectiveness of the device."
• Mentioning compliance with voluntary consensus standards (e.g., 21 C.F.R. § 1040.10 & 1040.11; IEC 60601 series; IEC 61000 series; IEC 60825-1).

Since the document does not include the requested information about acceptance criteria or a study proving device performance against such criteria, I cannot complete the table or answer the specific questions about sample sizes, ground truth, expert qualifications, or MRMC studies.

Therefore, the response is:

The provided document does not contain information about acceptance criteria or specific study data to prove the device meets acceptance criteria regarding clinical or analytical performance.

The document states that the device is substantially equivalent to predicate devices, implying that its safety and effectiveness are established through this comparison, rather than through new performance studies detailed in this summary. The "Technological Characteristics" section lists compliance with various voluntary consensus standards, which typically involve testing for electrical safety, electromagnetic compatibility, and laser safety, but these are not presented as performance criteria with specific results in this summary.

In summary, none of the requested information (points 1-9) regarding acceptance criteria and performance study details can be extracted from the provided text.

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