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PTFE SURGICAL SUTURE is indicated for use in all types of soft tissue approximation and/or ligation, including dental and general surgeries. The device is not indicated for use in cardiovascular surgery, ophthalmic surgery, and neural tissue.

PTFE SURGICAL SUTURE

I am sorry, but the provided text does not contain information about acceptance criteria or a study proving a device meets those criteria. The document is an FDA 510(k) clearance letter for a "PTFE Surgical Suture," which confirms its substantial equivalence to a predicate device.

The letter lists the device's name, regulation number, regulatory class, product code, and indications for use. However, it does not detail any specific performance acceptance criteria or describe a study that was conducted to demonstrate the device meets such criteria. Therefore, I cannot construct the table or answer the specific questions outlined in your request.

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PTFE Surgical Suture is indicated for use in all types of soft tissue approximation and/or ligation, including dental and general surgenes. The device is not in cardiovascular surgery, ophthalmic surgery, microsurgery, and neural tissue.

PTFE Surgical Suture

The provided document is a 510(k) premarket notification letter from the FDA for a PTFE Surgical Suture. It confirms the substantial equivalence of the device to a legally marketed predicate. However, it does not include information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications as typically found in a clinical study report or a more detailed submission.

Therefore, I cannot provide the requested information based on this document. The document primarily focuses on regulatory approval based on substantial equivalence to an existing device, rather than presenting a detailed performance study as would be done for an AI/ML medical device.

Ask a specific question about this device