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Bondek Synthetic Absorbable Surgical Suture is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular and neurological procedures.

Bondek Synthetic Absorbable Surgical Suture is a sterile, absorbable, braided multifilament suture composed of a homopolymer of glycolic acid, polyglycolic acid. The suture material is coated with a polycaprolactone-glycerol monostearate solution.

This document is a 510(k) summary for the Bondek® Synthetic Absorbable Surgical Suture. It establishes substantial equivalence to previously marketed devices and outlines the indications for use and device description. It does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of device performance metrics like sensitivity, specificity, or reader improvement with AI.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and the reported device performance
• Sample sized used for the test set and the data provenance
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts
• Adjudication method for the test set
• If a multi reader multi case (MRMC) comparative effectiveness study was done, and the effect size
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
• The type of ground truth used (expert consensus, pathology, outcomes data, etc)
• The sample size for the training set
• How the ground truth for the training set was established

This type of information is typically found in submissions for devices that involve diagnostic or AI components, where performance is measured against a ground truth. For sutures, the "performance" is generally related to material properties, biological compatibility, and mechanical strength, which are assessed through conformance to standards (e.g., USP, ISO 10993-1) as mentioned in the document. The document states:

"The determination of substantial equivalence for this device was based on a detailed device description, performance testing and conformance with voluntary performance standards, e.g. ISO 10993-1 Biological Evaluation of Medical Deices, U.S.P. Section 1475 - Absorbable Surgical Sutures, and the FDA Guidance Document "Alternate Suture Labeling Resulting from January 11, 1993 Meeting with HIMA"."

This indicates that the "acceptance criteria" were compliance with these established standards, and the "study" was the performance testing conducted to demonstrate this compliance. However, the specific data from these tests is not provided in this summary.

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