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UniCryl is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular procedures and neurological procedures.

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The document provided is a 510(k) premarket notification letter from the FDA for a device called "UniCryl," which is an absorbable poly(glycolide/L-lactide) surgical suture.

This type of FDA letter confirms substantial equivalence to a predicate device and permits marketing. It is not a study report or clinical trial document. Therefore, the provided document does not contain any of the requested information regarding acceptance criteria, device performance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.

The 510(k) process for devices like sutures primarily relies on demonstrating substantial equivalence to a legally marketed predicate device, often through material characterization, mechanical testing, and sometimes biocompatibility testing. It generally does not involve clinical studies with human readers or AI algorithms as would be the case for diagnostic imaging AI.

To answer your request, a different type of document, such as a clinical study report or a detailed 510(k) summary (which might include performance data if specifically required for a novel aspect), would be necessary.

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UniCryl M is indicated for use in general soft tissue approximation and/or ligation, including use in pediatric cardiovascular tissue where growth is expected to occur, and ophthalmic surgery but not for use in cardiovascular, neurological procedures, or microsurgery.

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The provided text is a 510(k) clearance letter from the FDA for a medical device called "UniCryl M," which is an absorbable polydioxanone surgical suture. It is a regulatory document and does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or any of the other technical details requested in your prompt.

Therefore, I cannot extract the requested information from this document. The document primarily focuses on the regulatory approval process and the determination of substantial equivalence to a predicate device.

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