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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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