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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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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.

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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