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UniPlain & UniChrom are 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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I am sorry, but the provided text is a 510(k) clearance letter for a medical device (surgical sutures) and does not contain any information about acceptance criteria, study details, or performance data for an AI/ML device. Therefore, I cannot generate the requested table and accompanying details based on the given input.

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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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UniMide is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.

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The provided text is a Food and Drug Administration (FDA) 510(k) clearance letter for a medical device called UniMide, which is a nonabsorbable polyamide surgical suture.

This document does not include information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment. The letter primarily focuses on the FDA's determination of substantial equivalence to a predicate device, allowing the manufacturer to market UniMide.

Therefore, I cannot fulfill your request for details on acceptance criteria and study information.

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UniEster C is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic and neurological cardiovascular, procedures.

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I apologize, but the provided text is a letter from the FDA regarding the 510(k) clearance of the UniEster C surgical suture. It does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth methods. Therefore, I cannot generate the requested table and study details based on this input.

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UniPro is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.

Nonabsorbable ploypropylene surgical suture

I am sorry, but based on the provided document, I cannot describe the acceptance criteria and the study that proves the device meets those criteria. The document is a 510(k) clearance letter from the FDA for a device called "UniPro", which is a nonabsorbable polypropylene surgical suture.

This type of document primarily confirms that the device is substantially equivalent to a legally marketed predicate device and outlines the regulatory framework. It does not contain information about:

• Specific acceptance criteria for device performance.
• The details of any studies (clinical or benchtop) conducted to demonstrate performance.
• Sample sizes for test or training sets.
• Ground truth establishment or expert qualifications.
• Adjudication methods.
• Multi-reader multi-case (MRMC) studies or standalone algorithm performance.

The document states the "Indications for Use" but does not delve into the technical performance metrics or the studies supporting them. These details would typically be found in the 510(k) submission itself, which is not provided here.

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UniSilk is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.

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The provided text is a 510(k) premarket notification letter from the FDA regarding the UniSilk surgical suture. It establishes substantial equivalence but does not contain any information about acceptance criteria, device performance metrics, study design, sample sizes, expert qualifications, or ground truth establishment relevant to AI/ML device evaluation.

Therefore, I cannot fulfill your request for the detailed information about acceptance criteria and the study that proves the device meets them, as none of that information is present in the provided document. The document pertains to a traditional medical device (suture) and its regulatory clearance, not an AI/ML diagnostic or prognostic tool.

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