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The nonabsorbable sutures (Monofilament Nylon, Polypropylene and Silk) are indicated for use in soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.

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This document is a 510(k) clearance letter from the FDA for a medical device, specifically nonabsorbable surgical sutures. It confirms that the device is substantially equivalent to a legally marketed predicate device.

The provided text does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria. The letter is an administrative clearance based on substantial equivalence to existing devices, not a detailed report of performance testing or clinical trials.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them, as this information is not present in the provided document.

To answer your request, I would need a document such as:

• A performance testing report.
• A clinical study report.
• The 510(k) summary or premarket notification submission itself, which would typically contain such information for device clearance.

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