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Absorbable Synthetic Suture with Needle Attachment (PGA BRAIDED) is indicated for use in general soft tissue approximation including ophthalmic surgery. Absorbable Synthetic Suture with Needle Attachment (PGA BRAIDED) is not indicated for cardiovascular and neurological tissue approximation.

Absorbable Synthetic Suture with Needle Attachment (PGA BRAIDED) is a synthetic absorbable suture based on Polyglycolic acid. Absorbable Synthetic Suture with Needle Attachment (PGA BRAIDED) coated with polycaprolactone and calcium stearate, has been found to be inert, non-antigenic and nonpyrogenic. Absorbable Synthetic Suture with Needle Attachment (PGA BRAIDED) are available dyed (violet) and undyed. Absorbable Synthetic Suture with Needle Attachment (PGA BRAIDED) complies with the requirements of USP and EP.

This document is a 510(k) summary for an Absorbable Synthetic Suture with Needle Attachment (PGA BRAIDED). It does not contain information about a study proving device performance against acceptance criteria in the context of an AI/ML medical device. Instead, it describes a traditional medical device (suture) and its substantial equivalence to predicate devices.

Therefore, I cannot provide the requested information as it pertains to AI/ML device studies. The document only covers:

• Acceptance Criteria and Reported Device Performance: Not applicable in the context of an AI/ML medical device performance study. The document states the suture "complies with the requirements of USP and EP," which are general standards for medical devices, not specific performance metrics in the way you might define them for an AI algorithm.
• Sample size used for the test set and the data provenance: Not applicable.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
• Adjudication method: Not applicable.
• MRMC comparative effectiveness study: Not applicable.
• Standalone performance: Not applicable.
• Type of ground truth used: Not applicable.
• Sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

This document is a regulatory submission demonstrating substantial equivalence for a medical suture, not a study evaluating an AI/ML device.

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