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REXSIN is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular or neural tissue.

Synthetic Absorbable PGA Suture With or Without Needle (REXSIN) are produced and provided by SM ENG Co., Ltd. REXSIN is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular or neural tissue. Suture of REXSIN is Trisorb manufactured by SAMY ANG Biopharmaceuticals Corporation. SM Eng is receiving bulk Trisorb from Samyang, and then go through cutting, adhesion of need and thread, winding and sterilization process according to SM Eng procedure, which becomes REXSIN suture. REXSIN is a sterilized medical device composed with absorbable, braided, coated suture with needle, stainless steel SUS 304. REXSIN Suture is a synthetic absorbable, braided, coated suture composed of a Polyglycolic acid (PGA). The suture is available undyed (natural) or dyed (D&C Violet No.2). Approximately over 65% of tensile strength remain after 2week. Complete absorption in tissues takes around 90 days. REXSIN Sutures meets requirements established by the United States Pharmacopoeia (USP) for Absorbable Surgical Sutures. REXSIN Sutures is available in 8-0, 7-0, 6-0, 5-0, 2-0, 0, 1 and 2, which are the sizes identified in the currently recognized United States.

The provided text is related to a 510(k) Pre-market Notification for a medical device (surgical suture). It describes the device, its intended use, and non-clinical tests conducted to demonstrate substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria for an AI/ML powered device, a study proving device performance against such criteria, or details regarding ground truth, expert consensus, or specific effect sizes for human readers with AI assistance.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and reported device performance.
• Sample size used for the test set and data provenance.
• Number of experts used to establish ground truth and their qualifications.
• Adjudication method.
• MRMC comparative effectiveness study results or effect sizes.
• Standalone algorithm performance.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

This document describes a traditional medical device (suture) and its non-clinical testing for substantial equivalence, not an AI/ML-powered diagnostic or decision-support system.

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