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The VARI-LASE procedure kit is indicated for the treatment of varicose veins and varicosities associated with superficial reflux of the Greater Saphenous Vein

The VARI-LASE procedure kit contains a 600um fiber and the following accessories used to gain endovascular access: 0.035" / 150cm stainless steel guide wire 5Fr/45cm introducer sheath 19 Gauge/7cm Percutaneous Entry Needle

The provided text is a 510(k) Summary for a medical device (Vari-Lase Endovenous Laser Procedure Kit) and the FDA's clearance letter. This type of regulatory submission typically focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through extensive clinical studies.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria. The reasons are as follows:

• No specific acceptance criteria are listed for device performance. The submission relies on comparing the device's characteristics and intended use to an already cleared (predicate) device.
• No detailed study is described to demonstrate performance against acceptance criteria. The "Summary of Non-Clinical Testing" mentions tests for integrity and biocompatibility of marker bands, but these are general safety and materials tests, not performance studies as typically envisioned for clinical efficacy.
• There is no mention of a test set, ground truth, experts, or adjudication methods. These are elements of a clinical trial designed to prove effectiveness, which is not the primary purpose of a 510(k) submission focused on substantial equivalence.
• No information on MRMC studies or standalone algorithm performance is present, as this device is a physical instrument, not an AI or imaging diagnostic tool.
• No sample size for training or establishment of ground truth for a training set is applicable here, again because it's not an AI or algorithm-driven device.

In summary, the provided document is a regulatory submission for substantial equivalence, not a performance study report. It shows that the device is considered safe and effective because it is very similar to other devices already on the market, not through a head-to-head performance study against derived acceptance criteria.

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