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ATOVEN-Reusable Laser Fiber is indicated for endovascular coagulation of the great saphenous vein in patients with superficial vein reflux. for the treatment of varicose veins and varicosities associated with superficial reflux of the great saphenous vein, and for the treatment of incompetence and reflux of superficial veins of the lower extremity.

The ATOVEN-Reusable Laser Fiber may be used with CW laser with wavelength range 810-1470 mm, a power range 5-15W, using an SMA905 connector.

ATOVEN-Reusable Laser Fiber is free-beam delivery device that transits laser energy into intended direction. Fiber length is 2.9mters. This device can be connected with SMA905 connector and deliver to 810~1470;m. This device can be connected with cleared surgical use laser diode.

ATOVEN-Reusable Laser Fiber consists of optic fiber. The optic fiber also consists of connector, optical fiber. Fiber cable is made of the optical fiber that delivers the laser beam. And the fiber may be used any laser wavelength between 810~1470 m that have been cleared for surgical use diode laser. Outer diameter of fiber cable is 0.6mm and length is 2900 mm.

The fiber core and cladding for the subject device are made from silica which is the same material used in the predicate device. This device can be connected with SMA905 connector.

This document is a 510(k) summary for the ATOVEN-Reusable Laser Fiber, a medical device used for endovascular coagulation of varicose veins. It doesn't contain the typical acceptance criteria and study design found in a clinical trial for an AI/CADe device. Instead, it details bench tests and biocompatibility tests conducted to demonstrate substantial equivalence to predicate devices.

Therefore, many of the requested fields cannot be directly extracted from this document, as they pertain to clinical performance studies of AI algorithms, which are not relevant to this type of device submission.

Here's a breakdown of what can be extracted and what cannot, based on the provided text:

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

The document lists various bench tests and biocompatibility tests performed. It states "The tests demonstrated that the device is as safe, as effective and performs in a substantially equivalent manner to the predicate device." However, it does not provide specific numerical acceptance criteria or quantitative performance results in a table format. The performance is broadly stated as meeting the standard for substantial equivalence.

Types of Tests Performed (Not acceptance criteria/performance in a table):

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

This document details bench tests and biocompatibility tests, not clinical studies with a test set of patient data. Therefore, information about a "test set" in the context of patient data, sample size for such a set, and data provenance (country, retrospective/prospective) is not applicable and not provided.

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)

This information is not applicable and not provided as there was no clinical test set requiring expert ground truth establishment for an AI/CADe device.

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

This information is not applicable and not provided for the same reason as above.

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

There was no MRMC comparative effectiveness study and thus no effect size for human readers with/without AI assistance, as this is not an AI/CADe device.

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

This is not an AI algorithm, so no standalone algorithm performance study was done.

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

Ground truth in the context of an AI/CADe device is not applicable. For the physical device, the "ground truth" for the bench and biocompatibility tests would be established by validated measurement standards and laboratory procedures.

8. The sample size for the training set

This is not an AI device, so there is no concept of a "training set" in the machine learning sense. The device is evaluated based on its physical properties and biocompatibility.

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

This is not applicable as there is no training set for an AI model.

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ATOVEN is a diode laser system designed to delivery of laser light to soft tissue during general surgery procedures. This device intended for treatment of reflux of the saphenous veins associated with varicose veins and varicosities. Non-Contact mode
ATOVEN is a diode laser system designed to delivery of laser light to soft tissue during general surgery procedures. This device intended for treatment of reflux of the saphenous veins of thigh associated with varicose veins and variosities. Non-Contact mode

ATOVEN Diode laser systems are Laser Surgery Systems that use optical energy radiated from semiconductor laser in order to cure varices. with Wave Length 1,470mm, and consists of CPU, LCD monitor, Cooling Systems, laser controller, Fiber optic pullback device included foot pedal switch. LED monitor are displaying various graphic to shows Operating Parameter, Mode, Time function, system status to user.

The provided text describes a 510(k) premarket notification for a medical device (ATOVEN) and does not contain information about a study proving the device meets specific acceptance criteria.

Instead, it focuses on demonstrating substantial equivalence to a predicate device based on common intended use, function, technology, operational principles, and performance. The document explicitly states: "No clinical standards have been established for Diode Laser, but did Safety and Performance test in accordance with below Standard." followed by a list of non-clinical safety and performance standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-1-2-22, IEC60825_1).

Therefore, I cannot provide a table of acceptance criteria and reported device performance directly from this document, nor can I answer questions related to sample sizes, expert qualifications, or comparative effectiveness studies, as these types of studies were not conducted or reported for this submission.

Here's a breakdown of what can be extracted and addressed:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document only states that these tests were "did" (performed) and that the device is substantially equivalent, implying that it met the requirements of these standards. Specific numerical performance data or pass/fail criteria for each standard are not provided.

Regarding the other requested information:

• 2. Sample sized 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 submission relies on non-clinical safety and performance tests to standards, not a clinical test set with a sample size of patients.

• 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 / Not provided. No clinical ground truth was established by experts for performance evaluation as part of this submission. The ground truth for proving safety and performance was adherence to the listed international safety standards.

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

  • Not applicable / Not provided. No clinical test set or adjudication was performed.

• 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 / Not provided. This device is a diode laser system, not an AI-assisted diagnostic tool, and no MRMC study was conducted or reported.

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

  • Not applicable / Not provided. This is not an algorithm; it's a medical device (laser system). Its performance is inherent in its design and manufacturing, verified against safety standards.

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

  • For the non-clinical tests, the "ground truth" was compliance with the specified international safety and performance standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-1-2-22, IEC 60825-1).

• 8. The sample size for the training set

  • Not applicable / Not provided. There is no "training set" as this is not a machine learning or AI device.

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

  • Not applicable / Not provided. As there is no training set, this question is not relevant.

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