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The LeMaitre Vascular Disposable Vein Stripper is designed for the removal of the long saphenous vein (LSV) by invagination stripping from the knee to the groin, without a distal incision for the treatment of varicose veins.

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I apologize, but the provided text from the FDA 510(k) approval letter for the LeMaitre Vascular Disposable Vein Stripper does not contain the specific information needed to answer your request regarding acceptance criteria and a study proving the device meets those criteria.

This document is a letter confirming the substantial equivalence of the device to a predicate device, allowing it to be marketed. It focuses on regulatory classification, general controls, and compliance requirements.

The document does NOT include the following information you requested:

• A table of acceptance criteria and the reported device performance.
• Sample size used for the test set and the data provenance.
• Number of experts used to establish the ground truth for the test set and their qualifications.
• Adjudication method for the test set.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size.
• If a standalone (algorithm only) performance study was done.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
• The sample size for the training set.
• How the ground truth for the training set was established.

Medical device clearance letters like this typically refer to information provided in the 510(k) submission, but they do not reproduce the detailed study results or performance data within the letter itself. To find the information you're looking for, you would generally need to consult the full 510(k) submission document, which is often not publicly available in its entirety in an easily searchable format.

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