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The Opus SmartStitch Suture Device is indicated for use for placement of #2 Braided Polyester Suture (such as Genzyme Polydek®) through soft tissue in endoscopic and other limited access procedures.

SmartStitch® Suture Device

I am sorry, but the provided text is a 510(k) clearance letter for the SmartStitch® Suture Device. It primarily focuses on regulatory approval and does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets those criteria.

Specifically, the document does not include:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets or data provenance.
• Information on experts used to establish ground truth.
• Adjudication methods.
• Results from multi-reader multi-case comparative effectiveness studies or standalone algorithm performance.
• Details about the type of ground truth used.
• Information regarding the training set size or how its ground truth was established.

The letter confirms that the device is "substantially equivalent" to a legally marketed predicate device, but it does not provide the technical performance study details that would typically be found in a 510(k) summary or an extensive clinical study report.

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