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Indicated for use in treatment of varicose veins and varicosities associated with superficial reflux of the greater saphenous vein.

The Ceralas D810 Diode Laser and the predicate devices operate with a power range of 1-60W in the CW or pulsed mode. The Ceralas D180 contains an ELVeS kit for gaining access to the vasculature to treat varicose veins and varicosities associated with superficial reflux of the greater saphenous vein.

This document is a 510(k) premarket notification for the Ceralas Diode Laser System and does not contain the detailed information required to answer your request. The provided text acts as a summary for the FDA's decision regarding substantial equivalence to predicate devices, rather than a full study report with acceptance criteria and performance data.

Here's why the requested information cannot be extracted from this document:

• No Acceptance Criteria or Device Performance Data: The document states the intended use and compares the new device's technological characteristics to predicate devices, but it does not define specific performance metrics, acceptance criteria, or present data from a study demonstrating the device meets those criteria.
• No Clinical Study Details: There is no mention of a specific clinical study conducted for this 510(k) submission. The document focuses on demonstrating substantial equivalence based on intended use and technological characteristics aligning with already cleared predicate devices. This type of submission often relies on design and performance testing, which is summarized as "technical differences... do not raise the question of safety or effectiveness," rather than a detailed clinical trial.
• No Information on Sample Sizes, Ground Truth, Experts, or Adjudication: Because a detailed clinical study is not presented, there is no information regarding sample sizes (test or training sets), data provenance, number or qualifications of experts, adjudication methods, or how ground truth was established.
• No MRMC or Standalone Performance Data: The document does not discuss any multi-reader multi-case comparative effectiveness studies or standalone algorithm performance, as these would typically be part of a more extensive clinical evaluation, which is not detailed here.

In summary, this 510(k) submission establishes substantial equivalence to existing devices based on device specifications and intended use, rather than through a new, full-scale clinical performance study with defined acceptance criteria and detailed results.

To answer your request, a document that describes a specific performance study (clinical or non-clinical) with predefined acceptance criteria and reported results would be needed.

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