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The AngioDynamics, Inc. NeverTouch II Fiber is indicated for endovascular coagulation of the great saphenous vein in patients with superficial vein reflux, for the treatment of variose veins and varicosties associated with superficial reflux of the great saphenous vein, and for the treatment of incomprence and reflux of superficial veins of the lower extremity.

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The provided document is a 510(k) premarket notification for a device modification, specifically for the "AngioDynamics, Inc. NeverTouch II 400µm Fiber and VenaCure Procedure Kit." This is not a study or research paper describing acceptance criteria and a study to prove a device meets those criteria. Instead, it's a regulatory submission affirming substantial equivalence to a legally marketed predicate device.

Therefore, the document does not contain the information requested in points 1-9 regarding acceptance criteria, device performance results, sample sizes for test/training sets, data provenance, expert qualifications, ground truth establishment, or any comparative effectiveness studies.

Here's why each point cannot be addressed from the given text:

1. A table of acceptance criteria and the reported device performance: The document states "Performance Standards: None Established" in section (j). It doesn't present any specific acceptance criteria (e.g., minimum accuracy, sensitivity, specificity) for the modified device or report performance metrics against such criteria. The submission is based on substantial equivalence, implying that if the modified device is substantially similar to the predicate and doesn't introduce new risks, specific performance testing against novel criteria isn't always required in the same way a de novo device might.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No test set, sample size, or data provenance is mentioned. This is a regulatory filing, not a clinical study report.
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): No mention of experts or ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable as there's no test set or study 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: Not applicable. This device is a surgical fiber, not an AI-powered diagnostic tool, and no MRMC study or AI assistance is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable. No ground truth is mentioned.
8. The sample size for the training set: Not applicable. No training set is mentioned.
9. How the ground truth for the training set was established: Not applicable. No training set or ground truth is mentioned.

The document is a communication from the FDA granting clearance for a modified medical device based on its substantial equivalence to previously cleared predicate devices, without detailed performance studies being explicitly presented within this particular submission.

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