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Surgisorb is indicated for use in general tissue approximation and or ligation, including use in ophthalmic procedures but not for use in cardiac or neurological procedures.

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I am unable to provide a description of acceptance criteria and study details based on the provided text. The document is an FDA clearance letter for a medical device (Surgisorb Surgical Suture) from 1999. It states that the device is "substantially equivalent" to previously regulated devices and outlines limitations and regulatory requirements.

However, the provided text does not contain any information about:

• Specific acceptance criteria for device performance.
• Details of any study that proves the device meets acceptance criteria (e.g., performance metrics, statistical results).
• Sample sizes, data provenance, ground truth establishment, expert qualifications, or adjudication methods for any test or training sets.
• Information on MRMC comparative effectiveness studies or standalone algorithm performance.

The letter focuses on regulatory approval and classification based on substantial equivalence, not on the detailed results of a performance study.

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