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The LeMaitre Occlusion Catheter is indicated for temporary vessel occlusion.

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I am sorry, but this document contains a letter from the FDA to a medical device manufacturer concerning the clearance of a "LeMaitre Occlusion Catheter." It does not contain information about acceptance criteria, device performance tables, sample sizes, expert qualifications, study designs (MRMC, standalone), or ground truth establishment relevant to an AI/ML device.

Therefore, I cannot provide the requested information based on the provided text.

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The LeMaitre Irrigation Catheters are used to irrigate arteries after thrombo-embolectomy, veins after thrombectomy, and the biliary tree after intraductal stone removal.

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The provided document is a 510(k) clearance letter from the FDA for the LeMaitre Irrigation Catheter. It states the device's substantial equivalence to a legally marketed predicate device for its indicated uses. However, this type of regulatory document does not contain the detailed information required to answer your request about acceptance criteria and a study proving device performance.

Specifically, the document does not include:

• A table of acceptance criteria and reported device performance.
• Information on a test set (sample size, data provenance).
• Number or qualifications of experts for ground truth.
• Adjudication method.
• Results from a multi-reader multi-case (MRMC) comparative effectiveness study.
• Results from a standalone algorithm performance study.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

This document is solely a regulatory approval based on the comparison to a predicate device, not a performance study report. To obtain the kind of information you are looking for, one would typically need access to the technical documentation submitted to the FDA, such as preclinical or clinical study reports, which are not usually made public in this format.

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The LeMaitre Venous Thrombectomy Catheter is indicated for the removal of venous thrombi.

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The provided text is a letter from the FDA regarding a 510(k) premarket notification for a medical device called the "LeMaitre Venous Thrombectomy Catheter". The letter primarily addresses the substantial equivalence of the device to legally marketed predicate devices and grants permission to market the device. It does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement as requested.

Therefore, I cannot provide the requested information based on the given text. The document is a regulatory approval letter, not a study report.

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The LeMaitre Balloon Catheter with Irrigation is indicated for the extraction of emboli and thrombi from the peripheral arterial system and also may be used for infusion of fluids.

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I am sorry, but the provided text does not contain information about acceptance criteria or a study that proves a device meets such criteria. The document is a 510(k) clearance letter from the FDA to a medical device manufacturer for a LeMaitre Balloon Catheter with Irrigation, stating that the device is substantially equivalent to legally marketed predicate devices. It outlines the indications for use but does not present any performance study data, acceptance criteria, sample sizes, expert qualifications, or other details typically found in a clinical or performance study report.

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The LeMaitre Biliary Catheter is indicated for the removal of stones and ductal debris.

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This document is correspondence from the FDA regarding a 510(k) premarket notification for the "LeMaitre Biliary Catheter." It is NOT a study report or a document describing acceptance criteria and device performance.

Therefore, I cannot provide the requested information about acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, or MRMC studies for this device based on the provided text. The document only states that the device is deemed "substantially equivalent" to legally marketed predicate devices for its stated indications for use (removal of stones and ductal debris).

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The LeMaitre Embolectomy Catheter is indicated for the removal of arterial emboli and thrombi.

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This looks like a 510(k) clearance letter from the FDA for a medical device called the "LeMaitre Embolectomy Catheter." This type of document does not contain the information requested about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert details for AI/device performance evaluation.

510(k) clearances are primarily based on demonstrating substantial equivalence to a predicate device, meaning the new device is as safe and effective as a legally marketed device. While manufacturers submit data to support their claims, the detailed study information as requested is not typically included in the final clearance letter itself. These letters acknowledge the submission and state the FDA's finding of substantial equivalence.

Therefore, I cannot provide the requested information from the provided text.

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Cuts saphenous vein valves during in situ bypass procedure in lower extremities.

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I am sorry, but based on the text provided, I cannot answer any of the questions regarding acceptance criteria or a study proving device performance. The document is an FDA 510(k) clearance letter for a medical device (2.0mm Expandable Lemaitre Valvulotome), which only confirms that the device is substantially equivalent to legally marketed predicate devices. It does not contain information about specific acceptance criteria, study details, sample sizes, expert qualifications, or ground truth methods.

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