Search Results

The absorbable sutures (Polydioxanone, Polyglactin and Polyglycolic Acid) are indicated for use in soft tissue approximation, including use in ophthalmic procedures, but not for use in cardiovascular and neurological procedures.

The absorbable sutures (Polyglecaprone) are indicated for use in soft tissue approximation, but not for use in ophthalmic procedures, cardiovascular and neurological procedures.

Not Found

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study proving that a device meets those criteria. The document is a 510(k) premarket notification letter from the FDA to Unilene, S.A.C. regarding their "VITAL SUTURES, SUTUREX, CIRUGIA PERUANA" device (absorbable polydioxanone surgical suture).

The letter primarily:

• States that the FDA has reviewed the 510(k) and determined the device is substantially equivalent to legally marketed predicate devices.
• Informs the company that they can market the device subject to general controls of the Act.
• Details the general controls and other FDA regulations that apply to the device.
• Provides contact information for further inquiries.

The "Indications for Use" section (page 2) describes the intended applications of the sutures but does not present any performance metrics, study results, or acceptance criteria.

Therefore, I cannot fulfill your request for information regarding acceptance criteria, device performance, study details, sample sizes, expert qualifications, or ground truth establishment based on the provided text.

Ask a specific question about this device