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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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Diotech Laser Fibers (400um, 600um) is indicated for endovascular coagulation of the great saphenous vein in patients with superficial vein reflux, for the treatment of varicose veins and varicosties 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 Diotech Laser Fibers (400um, 600um) may be used with CW laser with wavelength range 810-1470mm, a power range 5-15W, using an SMA905 connector.

Diotech Laser Fiber is free- beam delivery device that transits laser energy into intended direction. Fiber length is 2.9mters. And catheter tube length is 0.85meters. Catheter tube marked on per 10mm. This device can be connected with SMA905 connector and deliver to 810~1470m. This device can be connected with cleared surgical use laser diode. This device is single use only and sterilized by EO gas.

This document is a 510(k) premarket notification for the Diotech Laser Fiber, seeking substantial equivalence to a predicate device. It primarily focuses on comparing the new device's technical characteristics and intended use to a previously cleared device. Therefore, it does not contain the detailed clinical study information typically found in a post-market study or a full PMA application.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in the typical sense of quantitative thresholds for clinical performance. Instead, it relies on demonstrating substantial equivalence to a predicate device (AngioDynamics, Inc. NeverTouch 600mm Fiber) based on intended use, technological characteristics, and performance. The performance section mentions "bench tests," but only broadly states they demonstrated safety, effectiveness, and substantial equivalence. No specific quantitative performance metrics are provided for the Diotech Laser Fiber (e.g., success rates, complication rates).

The table below summarizes the comparison of key characteristics, implying that "performance" for this submission is met by being similar to the predicate.

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 mentions "Bench tests were performed," but does not specify any sample size for these tests. There is no information regarding the data provenance (country of origin, retrospective or prospective) as it was a bench study, not a clinical trial.

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 provided in the document as it describes bench testing, not clinical studies involving expert interpretation or ground truth establishment in a clinical context.

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

This information is not applicable and not provided as there was no clinical study with expert adjudication 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

No MRMC comparative effectiveness study was done or reported in this document. This submission is for a medical device (laser fiber) and not an AI-powered diagnostic or assistive tool.

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

This information is not applicable and not provided as the device is a physical medical instrument (laser fiber), not an algorithm or software.

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

The document mentions "Bench tests," which typically involve engineering assessments and material characterization. The "ground truth" for these tests would be the established scientific and engineering principles and standards (e.g., ISO10993 for biocompatibility) against which the device's physical properties and performance characteristics are measured. No clinical ground truth (like pathology or outcomes data) is mentioned as no clinical study was presented.

8. The sample size for the training set

The document describes bench testing and a comparison to a predicate device, not a machine learning model or algorithm. Therefore, there is no concept of a "training set" for this submission, and no sample size is applicable or provided.

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

As there is no training set for a machine learning model, this information is not applicable and not provided.

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