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USSC* POLYSORB* CSL** sutures and the existing USSC* POLYSORB* sutures are indicated for use in general soft tissue approximation and ophthalmic surgery but not use in cardiovascular or neural tissue.

USSC* POLYSORB* CSL** sutures and the existing USSC* POLYSORB* sutures are . composed of biosafe materials.

This document is a 510(k) Premarket Notification for a surgical suture (USSC POLYSORB CSL Suture). It is not a study describing the acceptance criteria and performance of an AI/ML-based medical device.

Therefore, I cannot provide the requested information, such as tables of acceptance criteria, device performance, sample sizes, expert qualifications, or details about AI/ML studies (MRMC, standalone).

The document's purpose is to demonstrate substantial equivalence to an already marketed device (USSC POLYSORB suture) based on:

• Biosafe materials
• Indications for use
• Manufacturing processes and controls
• Packaging processes and controls
• Sterilization processes and controls

It focuses on showing that the new suture is essentially the same as an existing one, not on providing performance metrics against specific acceptance criteria in the way an AI/ML device submission would.

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