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Absorbable Surgical Suture USP/EP is indicated for use in general soft tissue approximation and / or ligation in ophthalmic procedures. The safety and effectiveness of this suture in cardiovascular, neurological and micro surgery have not been established.

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Unfortunately, the provided document does not contain the specific information requested regarding "acceptance criteria and the study that proves the device meets the acceptance criteria." The document is a clearance letter from the FDA for a device called "Polycryl," an absorbable poly(glycolide/L-lactide) surgical suture.

While it mentions that the device is "substantially equivalent" to legally marketed predicate devices, it does not include:

• A table of acceptance criteria and reported device performance.
• Details about sample sizes, data provenance, or the number/qualifications of experts for a test set.
• Information on adjudication methods, MRMC studies, standalone performance, or the type of ground truth used.
• Details about the training set size or how its ground truth was established.

The document is purely an FDA clearance letter confirming substantial equivalence under a 510(k) pathway, and therefore does not delve into the detailed study results or performance metrics associated with acceptance criteria that would typically be found in a clinical study report or a more comprehensive FDA submission summary.

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